| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| An Open-label, Randomized Study to Assess the Relative Bioavailability (BA) and Bioequivalence (BE) of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer [NCT04577833] | Phase 1 | 136 participants (Actual) | Interventional | 2020-11-13 | Active, not recruiting |
| A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Re [NCT04497844] | Phase 3 | 696 participants (Actual) | Interventional | 2020-09-23 | Active, not recruiting |
| A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study) [NCT03732820] | Phase 3 | 796 participants (Actual) | Interventional | 2018-10-31 | Active, not recruiting |
| ANZadapt: Phase II Randomised Controlled Trial of Patient-specific Adaptive Versus Continuous Abiraterone or eNZalutamide in Metastatic Castration-resistant Prostate Cancer [NCT05393791] | Phase 2 | 168 participants (Anticipated) | Interventional | 2022-11-10 | Recruiting |
| A Phase 1b Clinical Trial of Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial) [NCT04477512] | Phase 1 | 18 participants (Actual) | Interventional | 2021-02-19 | Active, not recruiting |
| Phase 1, Open-Label, Single-Ascending Dose, Parallel Group Study to Determine the Pharmacokinetics, Safety, and Tolerability of ATRS-2002 Administered Subcutaneously in Healthy Adult Males [NCT04879589] | Phase 1 | 0 participants (Actual) | Interventional | 2022-09-01 | Withdrawn(stopped due to Study abandoned, no participants enrolled) |
| A Randomised, Double-Blind, Multicentre Phase Ⅲ Study to Evaluate Abiraterone Acetate Versus Placebo Combined With Prednisone in Subjects With Asymptomatic or Mild Symptoms Without Chemotherapy, Metastatic Castration Resistant Prostate Cancer. [NCT04056754] | Phase 3 | 268 participants (Actual) | Interventional | 2014-07-16 | Completed |
| An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy [NCT01217697] | | 0 participants | Expanded Access | | Approved for marketing |
| A Real-World Comparison of Clinical Outcomes in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer(mCRPC) Patients Who Initiated Enzalutamide vs. Abiraterone Acetate (Abiraterone) in Flatiron Electronic Health Record (EHR)Database [NCT05968599] | | 2,800 participants (Anticipated) | Observational | 2023-07-24 | Active, not recruiting |
| Effects of Metabolic Enzymes and Transporter Gene Polymorphisms on the Pharmacokinetics and Metabolism of Oral Abiraterone Acetate in Healthy Chinese Adults [NCT04735913] | Early Phase 1 | 81 participants (Anticipated) | Interventional | 2020-05-05 | Active, not recruiting |
| An Open-Label, Single-Arm, Multiple Center Extension Study to Evaluate One Year of Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With YONSA™ 500 mg (4 x 125 mg qd) With Methylprednisolone (4 mg Bid) [NCT02962284] | Phase 2 | 20 participants (Actual) | Interventional | 2016-11-30 | Completed |
| Randomized Phase-II Trial of Abiraterone Acetate Plus LHRH-therapy Versus Abiraterone Acetate Sparing LHRH-therapy in Patients With Progressive Chemotherapy-naïve Castration-resistant Prostate Cancer (SPARE) [NCT02077634] | Phase 2 | 68 participants (Actual) | Interventional | 2014-05-31 | Completed |
| A PHASE 4, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF CONTINUED ENZALUTAMIDE TREATMENT BEYOND PROGRESSION IN PATIENTS WITH CHEMOTHERAPY-NAÏVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER [NCT01995513] | Phase 4 | 509 participants (Actual) | Interventional | 2013-10-22 | Completed |
| A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy [NCT02159690] | Phase 2 | 0 participants (Actual) | Interventional | 2014-09-30 | Withdrawn(stopped due to loss of funding) |
| A Phase 3 Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer [NCT03009981] | Phase 3 | 504 participants (Anticipated) | Interventional | 2017-03-06 | Active, not recruiting |
| A Phase 2 Study Evaluating Activity of Zenocutuzumab (MCLA-128) in Patients With or Without Molecularly Defined Cancers [NCT05588609] | Phase 2 | 90 participants (Anticipated) | Interventional | 2022-11-17 | Recruiting |
| A Randomized Multicenter Phase III Trial Comparing Docetaxel or Hormone Therapy as Second Line Treatment in Patients With Asymptomatic or Oligosymptomatic Metastatic Castration-resistent Prostate Cancer (mCRPC) Progressing After Abiraterone or Enzalutamid [NCT04139772] | Phase 3 | 18 participants (Actual) | Interventional | 2019-09-01 | Active, not recruiting |
| A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy [NCT02405858] | Phase 4 | 51 participants (Actual) | Interventional | 2015-04-10 | Completed |
| A Single-Arm, Open-Label, Phase II Study of Systemic and Tumor Directed Therapy for Recurrent Oligometastatic M1 Prostate Cancer [NCT03902951] | Phase 2 | 28 participants (Actual) | Interventional | 2021-03-17 | Active, not recruiting |
| A Phase 3, Randomized, Open-Label, Controlled Study of Cabozantinib (XL184) in Combination With Atezolizumab vs Second Novel Hormonal Therapy (NHT) in Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT04446117] | Phase 3 | 575 participants (Actual) | Interventional | 2020-06-30 | Active, not recruiting |
| A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Abiraterone Acetate Coated Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Uncoated Tablet Formulation Under Fasted Condi [NCT02230046] | Phase 1 | 102 participants (Actual) | Interventional | 2014-10-31 | Completed |
| A Pilot Study of Adaptive Abiraterone Therapy for Metastatic Castration Resistant Prostate Cancer [NCT02415621] | Early Phase 1 | 19 participants (Actual) | Interventional | 2015-04-13 | Active, not recruiting |
| A Phase 1-2 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase Deficiency [NCT03548246] | Phase 2 | 0 participants (Actual) | Interventional | 2023-01-31 | Withdrawn(stopped due to This study plan has halted and was withdrawn from the IRB.) |
| A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA) [NCT05367440] | Phase 1/Phase 2 | 172 participants (Anticipated) | Interventional | 2022-06-02 | Recruiting |
| A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer [NCT03748641] | Phase 3 | 765 participants (Actual) | Interventional | 2019-01-25 | Active, not recruiting |
| A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer [NCT03431350] | Phase 1/Phase 2 | 136 participants (Actual) | Interventional | 2018-03-02 | Active, not recruiting |
| A Drug-Drug Interaction, Safety and Efficacy Study With JNJ-56021927 (ARN-509) and Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT02123758] | Phase 1 | 57 participants (Actual) | Interventional | 2014-07-09 | Active, not recruiting |
| Phase Ib, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN-509 in Combination With Abiraterone Acetate in Patients With Metastatic Castrate Resistant Prostate Cancer (CRPC [NCT01792687] | Phase 1 | 6 participants (Actual) | Interventional | 2013-02-05 | Active, not recruiting |
| A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease [NCT01314118] | Phase 2 | 131 participants (Actual) | Interventional | 2011-05-04 | Active, not recruiting |
| Phase Ib/II Clinical Study of TQB3616 Capsules in Combination With Abiraterone Acetate Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT05156450] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-01-01 | Not yet recruiting |
| A Phase II Study With a Lead-in Safety Phase of Abiraterone in Combination With PDMX1001/Niclosamide in Castration-Resistant Prostate Cancer (CRPC) [NCT02807805] | Phase 2 | 37 participants (Actual) | Interventional | 2016-10-31 | Active, not recruiting |
| The Evaluation of First-line Treatment Efficacy of Docetaxel and Abiraterone in Metastatic Castration-resistant Prostate Cancer Patients With Intraductal Carcinoma of the Prostate and the Exploration of the Genes Related to Treatment Effect [NCT03356444] | Phase 2 | 140 participants (Anticipated) | Interventional | 2017-11-30 | Not yet recruiting |
| A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (PROpel Study) [NCT05171816] | Phase 3 | 108 participants (Actual) | Interventional | 2021-06-24 | Active, not recruiting |
| A Single-Dose, Open-Label, Randomized, Crossover Study to Assess the Relative Bioavailability of Two Abiraterone Acetate Suspension Formulations Compared to the Abiraterone Acetate Tablet Formulation Under Fasted Condition in Healthy Adult Subjects [NCT01362764] | Phase 1 | 30 participants (Actual) | Interventional | 2011-05-31 | Completed |
| A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-Prostatectomy [NCT02849990] | Phase 2 | 22 participants (Actual) | Interventional | 2017-03-09 | Completed |
| Phase II Trial of Radiation With Androgen Deprivation: Abiraterone Acetate, Prednisone and Luteinizing Hormone Releasing Hormone Agonist Prior to Radiation Therapy [NCT01023061] | Phase 2 | 24 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer [NCT02949284] | Phase 2 | 90 participants (Anticipated) | Interventional | 2017-06-20 | Recruiting |
| A Study in Healthy Male Subjects Designed to Evaluate the Pharmacokinetic Profile of Abiraterone Following Administration of Immediate Release Formulations [NCT04295161] | Phase 1 | 33 participants (Actual) | Interventional | 2019-06-25 | Completed |
| A Phase 1 Study Evaluating the Efficacy and Safety of Sodium Selenite in Combination With Abiraterone in Patients With Castrate Resistant Prostate Cancer Progressing on Abiraterone [NCT04296578] | Phase 1 | 0 participants (Actual) | Interventional | 2020-10-31 | Withdrawn(stopped due to Study did not start) |
| Phase II Trial of Abiraterone Acetate in Patients With Relapsed and/or Metastatic, Castration Resistant Salivary Gland Cancers [NCT02867852] | Phase 2 | 24 participants (Actual) | Interventional | 2015-03-31 | Completed |
| A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Ascending Doses of AZD4635 Both as Monotherapy and in Combination in Patients With Advanced Solid Malignancies [NCT02740985] | Phase 1 | 313 participants (Actual) | Interventional | 2016-06-17 | Completed |
| A Phase 1b Study of EPI-7386 in Combination With Abiraterone Acetate Plus Prednisone or Apalutamide in mCRPC (ARES: Androgen Receptor Eradication Study) [NCT05295927] | Phase 1 | 3 participants (Actual) | Interventional | 2022-03-23 | Terminated(stopped due to Administrative Decision) |
| Advanced ChemoHormonal Therapy for Treatment Naïve Metastatic Prostate Cancer: Apalutamide and Abiraterone Acetate With Prednisone and Androgen Deprivation Therapy After Treatment With Docetaxel and Androgen Deprivation Therapy [NCT04267887] | Phase 2 | 7 participants (Actual) | Interventional | 2020-05-11 | Active, not recruiting |
| A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Chemotherapy-naive Metastatic Castration-resistant Prostate Cance [NCT02257736] | Phase 3 | 982 participants (Actual) | Interventional | 2014-11-30 | Active, not recruiting |
| A Randomized Study of Finite Androgen Ablation vs. Finite Androgen Ablation in Combination With Abiraterone Acetate and Prednisone in Patients With Prostate Cancer Who Have PSA Progression After Prostatectomy and/or Radiotherapy [NCT01786265] | Phase 2 | 310 participants (Anticipated) | Interventional | 2013-02-05 | Active, not recruiting |
| A Randomized Phase II Study of Sequencing Abiraterone Acetate and Enzalutamide in Metastatic Castration-Resistant Prostate Cancer [NCT02125357] | Phase 2 | 202 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Prostate Specific Membrane Antigen (PSMA) or Fluciclovine (FACBC) PET/CT Site-Directed Therapy of OLigometASTatic Prostate Cancer (P-Flu-BLAST-PC): A Multicenter Study [NCT04175431] | Phase 2 | 100 participants (Anticipated) | Interventional | 2020-09-30 | Recruiting |
| ACTION: Phase I/II Trial of Abiraterone Acetate in Combination With Tildrakizumab (Anti-IL23 Targeting Monoclonal Antibody) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC) [NCT04458311] | Phase 1/Phase 2 | 13 participants (Actual) | Interventional | 2020-12-01 | Active, not recruiting |
| A Multicenter, Randomized, Double-blind Phase Ib/III Clinical Study of Dalpiciclib Isethionate Tablets Combined With Abiraterone Acetate Tablets (I) and Prednisone Tablets (AA-P) Versus Placebo Combined With AA-P in Treatment of High-volume, Metastatic, H [NCT06099990] | Phase 1 | 660 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| An Open-label Phase 2 Multi-center Study of Enzalutamide and Abiraterone and Biomarkers of Androgen Response and Resistance During Rising PSA: BARRIER-P Trial [NCT02429193] | Phase 2 | 16 participants (Anticipated) | Interventional | 2016-03-31 | Completed |
| Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies [NCT01254864] | Phase 2 | 190 participants (Actual) | Interventional | 2011-03-16 | Completed |
| Long-term Effects of Enhanced Systemic Therapy and Tumor-directed Therapy for Newly Diagnosed Oligometastatic Prostate Cancer Confirmed by Conventional Imaging Modality: a Prospective, Single-arm Study. [NCT05212857] | Phase 2 | 160 participants (Anticipated) | Interventional | 2022-04-30 | Recruiting |
| An Observational Study of Continuous Oral Dosing of an Irreversible CYP17 Inhibitor, Abiraterone Acetate (CB7630), in Castration-Resistant Prostate Cancer Patients Evaluating Androgens and Steroid Metabolites in Bone Marrow Plasma [NCT00544440] | Phase 2 | 57 participants (Actual) | Interventional | 2007-10-31 | Completed |
| A Cancer Research UK Phase I/II Open Label Study to Evaluate the Safety, Endocrine Effects and Anti-tumour Activity of Abiraterone Acetate (CB7630) in Patients With Oestrogen (ER) or Androgen Receptor (AR) Positive Advanced or Metastatic Breast Carcinoma [NCT00755885] | Phase 1/Phase 2 | 77 participants (Actual) | Interventional | 2008-10-31 | Completed |
| An Abiraterone Acetate Plus Prednisone Drug-Drug Interaction Study With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01017939] | Phase 1 | 34 participants (Actual) | Interventional | 2010-01-31 | Completed |
| A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer [NCT00887198] | Phase 3 | 1,088 participants (Actual) | Interventional | 2009-04-28 | Completed |
| Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC-RP Trial): A Randomized, Open-label, Multi-centre Phase-2 Study Evaluating the Pathological Complete Response (pCR) Rate Following Neoadjuvant Therapy in Participants With [NCT02543255] | Phase 2 | 76 participants (Actual) | Interventional | 2016-09-30 | Completed |
| A QT/QTc and Multi-dose PK Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration- Resistant Prostate Cancer [NCT00910754] | Phase 1 | 33 participants (Actual) | Interventional | 2009-05-31 | Completed |
| A Phase 1 Study of Abemaciclib in Combination With Other Anti-Cancer Therapy in Japanese Patients With Advanced Cancer [NCT04071262] | Phase 1 | 6 participants (Actual) | Interventional | 2019-12-20 | Completed |
| A Randomized, Open-label, Four-sequence, Four-period, Crossover, Single Dosing, Phase 1 Clinical Trial to Compare the Safety, Tolerability, and Pharmacokinetics of SOL-804 and Zytiga in Healthy Male Subjects [NCT06014853] | Phase 1 | 48 participants (Anticipated) | Interventional | 2023-08-07 | Recruiting |
| A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib+Abiraterone Versus Placebo+Abiraterone as Treatment for Patients With DeNovo Metastatic Hormone-Sensitive Prostate Cancer Characterised by PTE [NCT04493853] | Phase 3 | 1,000 participants (Anticipated) | Interventional | 2020-07-13 | Recruiting |
| An Open-label Extension (OLE), Expanded Access Study, to Assess Long-term Safety of SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) With Methylprednisolone (4mg Bid) in Patients Who Completed Study Number CHL-AA-201 [NCT02887976] | Phase 3 | 2 participants (Actual) | Interventional | 2016-09-30 | Completed |
| An Open Label Biomarker Driven Phase II Clinical Trial of Abiraterone Acetate (AA) Re-Challenge in Patients With Metastatic Castration-Resistant Prostate Cancer and Prior Response to AA [NCT02656615] | Phase 2 | 4 participants (Actual) | Interventional | 2016-01-31 | Terminated(stopped due to Lack of Patient accrual) |
| A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-b [NCT06136624] | Phase 3 | 1,200 participants (Anticipated) | Interventional | 2023-12-22 | Not yet recruiting |
| A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone [NCT01685268] | Phase 1/Phase 2 | 49 participants (Actual) | Interventional | 2012-09-30 | Completed |
| ACADEMIC: A Randomized Phase II Clinical Trial of ADT Combined With Abiraterone or Docetaxel in Metastatic Hormone Sensitive Prostate Cancer [NCT03827473] | Phase 2 | 1 participants (Actual) | Interventional | 2019-02-08 | Terminated(stopped due to The trial was closed because the changing standard of care landscape, making this trial not impactful anymore.) |
| Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race [NCT03098836] | Phase 2 | 93 participants (Actual) | Interventional | 2017-07-10 | Active, not recruiting |
| Pharmacokinetic Food-effect Study of Abiraterone Acetate (A.A) in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) [NCT02730975] | Phase 1 | 42 participants (Actual) | Interventional | 2014-05-12 | Completed |
| An Open-Label Drug-Drug Interaction Study to Assess the Effect of Abiraterone (JNJ-589485) on the Pharmacokinetics of Pioglitazone Following Administration of Abiraterone Acetate (JNJ-212082) and Pioglitazone HCl Tablets in Healthy Male Subjects [NCT01873001] | Phase 1 | 16 participants (Actual) | Interventional | 2013-05-31 | Completed |
| Investigator-Initiated, Pilot Translational Study of Circulating Tumor Cells to Identify Predictive Factors of Response to Abiraterone Acetate in Men With Castration-Resistant Prostate Cancer [NCT01961843] | | 40 participants (Actual) | Interventional | 2013-10-31 | Active, not recruiting |
| Open-Label Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer [NCT01834209] | | 0 participants | Expanded Access | | No longer available |
| Phase II Clinical Trial of Abiraterone Acetate Without Exogenous Glucocorticoids in Men With Castration-resistant Prostate Cancer With Correlative Assessment of Hormone Intermediates. [NCT02025010] | Phase 2 | 60 participants (Actual) | Interventional | 2014-01-27 | Active, not recruiting |
| Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II [NCT01309672] | Phase 2 | 41 participants (Actual) | Interventional | 2011-08-09 | Active, not recruiting |
| A Phase II Open Label Study of CB7630 (Abiraterone Acetate) and Prednisone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy [NCT00485303] | Phase 2 | 58 participants (Actual) | Interventional | 2007-06-30 | Completed |
| A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting. The COSMiC Prospective Prostate Cancer Registry [NCT02364531] | | 194 participants (Actual) | Observational | 2014-09-30 | Completed |
| A Phase I, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of AZD8186 in Patients With Advanced Castration-resistant Prostate Cancer (CRPC), Squamous Non-Small Cell [NCT01884285] | Phase 1 | 147 participants (Actual) | Interventional | 2013-07-09 | Completed |
| A Phase I/II Open Label Study of the 17α-Hydroxylase/ C17,20 Lyase Inhibitor, Abiraterone Acetate in Patients With Prostate Cancer Who Have Failed Hormone Therapy [NCT00473512] | Phase 1/Phase 2 | 54 participants (Actual) | Interventional | 2005-11-30 | Completed |
| An Open-Label, Phase I, Randomized Pharmacokinetic Study of Dietary Effects on Abiraterone Acetate Drug Levels in Patients With Metastatic Castration-Resistant Prostate Cancer (DEAL) [NCT01913015] | Phase 1 | 3 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to After enrollment of the first 3 subjects, an interim assessment was conducted. Comparing DBS sampling to plasma PK levels yielded unconvincing results.) |
| An Evolutionary Double Bind Phase II Neoadjuvant Study of Abiraterone Acetate, Leuprolide Acetate, and Belzutifan in Men With Regional Prostate Cancer Eligible for Prostatectomy [NCT05574712] | Phase 2 | 30 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
| A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of AZD5305 in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01) [NCT06120491] | Phase 3 | 1,800 participants (Anticipated) | Interventional | 2023-11-21 | Recruiting |
| A Randomized Phase 2 Study of Cabozantinib (XL184) in Combination With Abiraterone in Chemotherapy Naïve Subjects With Bone-Metastatic Castration-Resistant Prostate Cancer [NCT01995058] | Phase 2 | 54 participants (Actual) | Interventional | 2013-12-31 | Terminated(stopped due to Study stopped after results of cabozantinib Phase 3 CRPC study XL184-307.) |
| A Phase 1 Single Dose Open-Label Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function [NCT02001571] | Phase 1 | 24 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Phase II Study of Talazoparib With Androgen Deprivation Therapy and Abiraterone in Castration Sensitive Prostate Cancer [NCT04734730] | Phase 2 | 70 participants (Anticipated) | Interventional | 2021-05-04 | Recruiting |
| A Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With Metastatic Castrate Resistant Prostate Cancer (mCRPC) [NCT02913196] | Phase 1 | 16 participants (Actual) | Interventional | 2016-12-30 | Active, not recruiting |
| A Phase 3, Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hor [NCT06136650] | Phase 3 | 1,500 participants (Anticipated) | Interventional | 2023-12-18 | Recruiting |
| A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone [NCT01088529] | Phase 2 | 66 participants (Actual) | Interventional | 2009-12-31 | Completed |
| A Phase II Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy [NCT00474383] | Phase 2 | 47 participants (Actual) | Interventional | 2006-11-30 | Completed |
| A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Relative Bioavailability of 3 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male [NCT01640093] | Phase 1 | 32 participants (Actual) | Interventional | 2012-05-31 | Completed |
| Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity, PSA Decline and Genetic Variation in Proteins Involved in Androgen Metabolism in Metastatic Hormone Naive Prostate Cancer [NCT03833921] | Phase 2 | 130 participants (Anticipated) | Interventional | 2019-05-23 | Recruiting |
| A Dynamic Allocation Modular Sequential Trial of Approved and Promising Therapies in Men With Metastatic Castrate Resistant Prostate Cancer [NCT02703623] | Phase 2 | 196 participants (Actual) | Interventional | 2016-05-18 | Active, not recruiting |
| A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy [NCT00638690] | Phase 3 | 1,195 participants (Actual) | Interventional | 2008-05-31 | Completed |
| A Phase 1 PK and Dose Escalation and Expansion Study of DST-2970 in Patients With Prostate Cancer With Rising PSA on Treatment With Abiraterone Acetate [NCT04291664] | Phase 1 | 54 participants (Anticipated) | Interventional | 2020-01-31 | Active, not recruiting |
| ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer [NCT03903835] | Phase 3 | 750 participants (Anticipated) | Interventional | 2019-02-01 | Recruiting |
| A Phase II Randomized Study of Enzalutamide+Leuprolide Versus Enzalutamide+Leuprolide+Abiraterone Acetate+Prednisone as Neoadjuvant Therapy for HIgh-Risk Prostate Cancer Undergoing Prostatectomy [NCT02268175] | Phase 2 | 75 participants (Actual) | Interventional | 2014-10-31 | Completed |
| A Multicenter, Open-Label, Parallel, Phase 1b/2a Study of PLX2853 in Combination With Abiraterone Acetate and Prednisone and Phase 1b/2a Study of PLX2853 in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) [NCT04556617] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2020-09-21 | Terminated(stopped due to study terminated due to business realignment) |
| Phase Ib/II Trial of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-365) [NCT02861573] | Phase 1/Phase 2 | 1,200 participants (Anticipated) | Interventional | 2016-11-17 | Recruiting |
| Phase Ib/II Clinical Study of TQB3823 Tablets Combined With Abiraterone Acetate Tablets and Prednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer [NCT05405439] | Phase 1/Phase 2 | 39 participants (Actual) | Interventional | 2022-08-25 | Terminated(stopped due to The sponsor voluntarily terminated the study) |
| Pharmacogenetic Study in Castration-resistant Prostate Cancer Patients Treated With Abiraterone Acetate [NCT01858441] | | 148 participants (Actual) | Interventional | 2013-04-30 | Completed |
| Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University [NCT04356430] | Phase 2 | 75 participants (Anticipated) | Interventional | 2019-04-01 | Active, not recruiting |
| A Pharmacokinetics Study to Assess the Oral Administration of CB7630 (Abiraterone Acetate) Capsule Formulation and Tablet Formulation in Patients With Prostate Cancer [NCT00600535] | Phase 1 | 31 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Intra-individual Dose Escalation of Abiraterone Acetate According to Its Plasma Concentration in Patients With Progressive Castration-resistant Metastatic Prostate Cancer [NCT03458247] | Phase 2 | 94 participants (Actual) | Interventional | 2018-06-22 | Completed |
| A Safety and Pharmacokinetics Study of Niraparib Plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate Plus Prednisone) in Men With Metastatic Castration-Resistant Prostate Cancer [NCT02924766] | Phase 1 | 34 participants (Actual) | Interventional | 2016-10-03 | Completed |
| A Phase 2 Randomized Study of YONSA® (Abiraterone Acetate), Enzalutamide or Apalutamide as First Line Therapy in Veterans With Castrate-sensitive Prostate Cancer [NCT05422911] | Phase 2 | 200 participants (Anticipated) | Interventional | 2022-06-30 | Not yet recruiting |
| A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects [NCT01678573] | Phase 1 | 15 participants (Actual) | Interventional | 2012-07-31 | Completed |
| A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer [NCT03587285] | Phase 1/Phase 2 | 11 participants (Actual) | Interventional | 2018-09-23 | Active, not recruiting |
| A Phase 2, Study of Apalutamide and Abiraterone Acetate in Castration-Resistant Metastatic Prostate Cancer Patients Evaluating a Predetermined Biomarker Signature [NCT03360721] | Phase 2 | 7 participants (Actual) | Interventional | 2018-03-06 | Active, not recruiting |
| Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer. [NCT03348670] | Phase 2/Phase 3 | 600 participants (Anticipated) | Interventional | 2023-08-18 | Active, not recruiting |
| An Exploratory Randomized Phase II Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer [NCT02218606] | Phase 2 | 80 participants (Actual) | Interventional | 2014-08-31 | Completed |
| A Phase 2 Course Determining Study for Men With Hormone-Naïve Metastatic Prostate Cancer (HNMPCa) [NCT03821792] | Phase 2 | 60 participants (Anticipated) | Interventional | 2019-07-22 | Active, not recruiting |
| A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study [NCT02960022] | Phase 2 | 900 participants (Anticipated) | Interventional | 2016-12-22 | Recruiting |
| A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal [NCT02987543] | Phase 3 | 387 participants (Actual) | Interventional | 2017-02-06 | Completed |
| A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC) [NCT01715285] | Phase 3 | 1,209 participants (Actual) | Interventional | 2013-02-12 | Completed |
| Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer [NCT04812366] | Phase 2 | 315 participants (Anticipated) | Interventional | 2021-09-21 | Recruiting |
| Phase I/II Open Label Dose Escalation Study of the 17α-Hydroxylase/ C17,20-Lyase Inhibitor, Abiraterone Acetate in Hormone Refractory Prostate Cancer [NCT00473746] | Phase 1/Phase 2 | 66 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Phase II Trial of Abiraterone Acetate Combined With Dutasteride With Correlative Assessment of Tumor Androgen Levels and Androgen Receptor Sequence and Signaling at Baseline and at Progression [NCT01393730] | Phase 2 | 40 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy [NCT01381874] | Phase 2 | 297 participants (Actual) | Interventional | 2011-08-24 | Completed |
| Durvalumab and Standard Chemotherapy for the Treatment of Lymph Node Positive Bladder Cancer [NCT05137262] | Phase 2 | 60 participants (Anticipated) | Interventional | 2021-10-13 | Recruiting |
| Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer. [NCT01845792] | Phase 2 | 7 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to Low accrual) |
| A Randomized, Open-Label, Active-Controlled, Multi-Center Study to Evaluate Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer: The STAAR STUDY [NCT02737332] | Phase 2 | 53 participants (Actual) | Interventional | 2016-03-21 | Completed |
| A Randomized Phase II Trial of Dasatinib Plus Abiraterone Compared to Abiraterone Alone for Metastatic, Castration-Resistant Prostate Cancer Prior to Chemotherapy [NCT01685125] | Phase 2 | 96 participants (Anticipated) | Interventional | 2012-09-30 | Active, not recruiting |
| A Phase 1, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral EPI-7386 in Patients With Castration-Resistant Prostate Cancer [NCT04421222] | Phase 1 | 99 participants (Anticipated) | Interventional | 2020-06-23 | Recruiting |
| An Open-Label, Multiple-Dose, Dose-Finding Study of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency [NCT01495910] | Phase 1 | 6 participants (Actual) | Interventional | 2011-12-31 | Completed |
| An Open-Label Drug-Drug Interaction Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects [NCT01655147] | Phase 1 | 19 participants (Actual) | Interventional | 2012-01-31 | Completed |
| An Expanded Access Open Label Study of CB7630 (Abiraterone Acetate) in Patients With Advanced Prostate Cancer Who Have Completed CB7630 Clinical Study COU-AA-001 [NCT01664728] | Phase 1 | 54 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Post-marketing Surveillance Study on the Safety and Effectiveness of Abiraterone Acetate Among Adult Filipino Male Patients With Metastatic Advanced Prostate Cancer [NCT01692483] | | 0 participants (Actual) | Observational | 2013-07-31 | Withdrawn(stopped due to Sponsor determined study is not required according to PFDA Circular 2013-004) |
| Phase II Single-arm Study Evaluating Neo-adjuvant (Pre-radical Radiotherapy) Abiraterone Acetate (Plus Prednisolone) and Gonadotropin-Releasing Hormone (GnRH) Agonist in High Risk Localised Prostate Carcinoma [NCT02160353] | Phase 2 | 45 participants (Actual) | Interventional | 2015-07-09 | Completed |
| A Phase 1 Single Dose Open-Label Reduced/Staged Pharmacokinetic Study of Abiraterone Acetate in Male Subjects With Impaired Renal Function Compared to Matched Control Subjects With Normal Renal Function [NCT01715259] | Phase 1 | 16 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Erdafitinib Plus Abiraterone Acetate or Enzalutamide in Double Negative Prostate Cancer [NCT03999515] | Phase 2 | 3 participants (Actual) | Interventional | 2020-04-27 | Terminated(stopped due to Terminated due to slow accrual) |
| Pre-operative Assessment of the Anti-Proliferative Effects and Genomic Alterations of 2 Weeks of Abiraterone Acetate Compared to 2 Weeks of an Aromatase Inhibitor in Post-menopausal Hormone Receptor Positive Operable Breast Cancer [NCT01814865] | Phase 2 | 0 participants (Actual) | Interventional | 2013-05-31 | Withdrawn(stopped due to Funding was not acquired) |
| A Phase II Trial Evaluating the Activity of Abiraterone Acetate Plus Prednisone in Patients With a Molecular Apocrine HER2-negative Locally Advanced or Metastatic Breast Cancer [NCT01842321] | Phase 2 | 34 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Phase II, Randomized, Open-label, Multicenter Study in Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Who Have PRIMary Resistance to Abiraterone Acetate or Enzalutamide Treatment Comparing the Anti-tumor Effect of CABa [NCT02379390] | Phase 2 | 8 participants (Actual) | Interventional | 2015-06-17 | Terminated(stopped due to Unsatisfactory patient accrual) |
| A Multicenter Phase I/II Trial of Abiraterone Acetate + BEZ235 in Metastatic, Castration-Resistant Prostate Cancer [NCT01717898] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2013-01-31 | Terminated(stopped due to Dose limiting toxicities on lowest dose level) |
| A Prospective Randomized Pilot Study Evaluating the Food Effect on the Pharmacokinetics and Pharmacodynamics of Abiraterone Acetate in Men With Castrate Resistant Prostate Cancer [NCT01543776] | Phase 2 | 72 participants (Actual) | Interventional | 2012-01-31 | Completed |
| A Phase 3b Multicenter, Open-label Abiraterone Acetate Long-term Safety Study [NCT01517802] | Phase 3 | 32 participants (Actual) | Interventional | 2012-03-28 | Completed |
| A Phase II Open-label, Parallel Group Study of Abiraterone Acetate Plus Prednisone in African American and Caucasian Men With Metastatic Castrate-resistant Prostate Cancer [NCT01940276] | Phase 2 | 100 participants (Actual) | Interventional | 2013-10-31 | Completed |
| Pre-Approval Access Single Patient Request for Niraparib / Abiraterone Acetate Combination (Nira/AA Combination) [NCT05401214] | | 0 participants | Expanded Access | | Approved for marketing |
| An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination, in Patients With Advanced Solid/Metastatic Tumours. [NCT03568656] | Phase 1/Phase 2 | 350 participants (Anticipated) | Interventional | 2018-07-23 | Recruiting |
| A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy [NCT03777982] | Phase 3 | 400 participants (Anticipated) | Interventional | 2020-04-20 | Active, not recruiting |
| A Single-center, Single-arm, Prospective Study to Investigate the Efficacy and Safety of Olaparib Combined With Abiraterone and Prednisone in mHSPC Patients With HRR Gene Mutation [NCT05167175] | Phase 2 | 30 participants (Anticipated) | Interventional | 2022-03-01 | Recruiting |
| Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer [NCT03565835] | Phase 2 | 32 participants (Actual) | Interventional | 2018-06-13 | Active, not recruiting |
| A Phase II Trial of Abiraterone Acetate, Radiotherapy and Short-Term Androgen Deprivation in Men With Unfavorable Risk Localized Prostate Cancer [NCT01717053] | Phase 2 | 37 participants (Actual) | Interventional | 2014-01-17 | Completed |
| A Phase 2, Randomized, 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical [NCT01751451] | Phase 2 | 124 participants (Actual) | Interventional | 2012-12-18 | Completed |
| The Pacific Clinical Trial: A Randomized Phase II Study Evaluating OGX-427 in Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC)Who Have Prostate-Specific Antigen (PSA) Progression While Receiving Abiraterone: Hoosier Oncology Group GU12- [NCT01681433] | Phase 2 | 72 participants (Actual) | Interventional | 2012-12-31 | Terminated(stopped due to lack of accrual) |
| Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer [NCT03016741] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-03-31 | Recruiting |
| A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01591122] | Phase 3 | 313 participants (Actual) | Interventional | 2012-03-27 | Completed |
| A Phase II Study of Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) and Prior Therapy With Ketoconazole [NCT01199146] | Phase 2 | 42 participants (Actual) | Interventional | 2010-09-10 | Completed |
| A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer [NCT03706365] | Phase 2/Phase 3 | 350 participants (Anticipated) | Interventional | 2018-11-26 | Active, not recruiting |
| A Randomized Open-label Phase IIa Study Evaluating Quantified Bone Scan Response Following Treatment With Radium-223 Dichloride Alone or in Combination With Abiraterone Acetate or Enzalutamide in Subjects With Castration-resistant Prostate Cancer Who Have [NCT02034552] | Phase 2 | 68 participants (Actual) | Interventional | 2014-03-07 | Completed |
| A Randomized, Open Label, Multicenter Study of Cabazitaxel Versus an Androgen Receptor (AR)-Targeted Agent (Abiraterone or Enzalutamide) in mCRPC Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent (CARD) [NCT02485691] | Phase 4 | 255 participants (Actual) | Interventional | 2015-11-09 | Completed |
| Phase 3 Study Investigating the Efficacy and Safety of TAVT-45 (Abiraterone Acetate) Granules for Oral Suspension (Novel Abiraterone Acetate Formulation) Relative to a Reference Abiraterone Acetate Formulation in Patients With mCSPC & mCRPC [NCT04887506] | Phase 3 | 107 participants (Actual) | Interventional | 2021-04-14 | Completed |
| A Phase I/II Study of Alisertib in Combination With Abiraterone and Prednisone for Patients With Castration-Resistant Prostate Cancer After Progression on Abiraterone [NCT01848067] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2013-08-14 | Completed |
| A Real-World Comparison of Clinical Outcomes in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Initiated Enzalutamide vs. Abiraterone Acetate (Abiraterone) in the 100% Medicare Fee-For-Service (FFS) Data (2009-2020 [NCT05520138] | | 5,506 participants (Actual) | Observational | 2022-08-29 | Completed |
| Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma [NCT03436654] | Phase 2 | 112 participants (Anticipated) | Interventional | 2018-06-21 | Recruiting |
| A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer After Prostatectomy [NCT03043807] | Phase 2 | 26 participants (Actual) | Interventional | 2017-02-22 | Completed |
| A Single-center, Phase II Neoadjuvant Study of Abiraterone Acetate in the Treatment of Intraductal Carcinoma of the Prostate [NCT04736108] | Phase 2 | 50 participants (Anticipated) | Interventional | 2021-05-31 | Not yet recruiting |
| Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses [NCT03649841] | Phase 2 | 10 participants (Actual) | Interventional | 2020-06-29 | Terminated(stopped due to Terminated due to low accrual.) |
| A Randomized, Open-label, Phase 2 Trial of Sipuleucel-T With Concurrent Versus Sequential Administration of Abiraterone Acetate Plus Prednisone in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC) [NCT01487863] | Phase 2 | 69 participants (Actual) | Interventional | 2011-12-31 | Completed |
| Open Label Pharmacodynamic Study of Abiraterone Acetate in the Treatment of Metastatic, Castration Resistant Prostate Cancer [NCT01503229] | Phase 2 | 32 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Bioequivalence of Abiraterone Acetate in Healthy Chinese Volunteers: an Open, Randomized, Single-dose, Three-cycle, Three-sequence Crossover Study [NCT04863105] | Phase 1 | 36 participants (Actual) | Interventional | 2017-11-24 | Completed |
| A Randomized, Open-Label, Multi-Center, Parallel Controlled Study Comparing the Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer After Oral Administration of Abiraterone Acetate Tablets (I) or ZYTIGA® [NCT04862091] | Phase 2 | 69 participants (Actual) | Interventional | 2021-04-23 | Completed |
| Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC [NCT02426333] | | 56 participants (Actual) | Observational | 2016-01-31 | Completed |
| PEAX: Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge®), Abiraterone Acetate (Zytiga®) or Enzalutamide (Xtandi®) Undergoing Cardiopulmonary EXercise Testing [NCT02353715] | | 38 participants (Actual) | Observational | 2015-07-07 | Completed |
| A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone With or Without ABT-888 for Patients With Metastatic Castration-Resistant Prostate Cancer [NCT01576172] | Phase 2 | 159 participants (Actual) | Interventional | 2012-03-30 | Completed |
| A Phase II Study of Dovitinib (TKI258) Combined With Abiraterone Acetate in Patients With Metastatic Castrate-Resistant Prostate Cancer Evaluating Markers of FGF and AR Signaling in Bone Marrow and Plasma [NCT01994590] | Phase 2 | 4 participants (Actual) | Interventional | 2014-05-19 | Terminated(stopped due to Sponsor stopped supplying study drug) |
| TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency [NCT02975934] | Phase 3 | 405 participants (Actual) | Interventional | 2017-06-13 | Active, not recruiting |
| Cabazitaxel With Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial [NCT03419234] | Phase 2 | 223 participants (Actual) | Interventional | 2018-04-26 | Active, not recruiting |
| Activity of Abiraterone Acetate in the Management of Cushing's Syndrome in Patients With Adrenocortical Carcinoma [NCT03145285] | Phase 2 | 10 participants (Anticipated) | Interventional | 2017-04-18 | Active, not recruiting |
| A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy [NCT01695135] | Phase 3 | 214 participants (Actual) | Interventional | 2012-08-09 | Completed |
| A Pre-Operative Study to Assess the Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence [NCT03279250] | Phase 2 | 86 participants (Actual) | Interventional | 2017-10-13 | Completed |
| Phase 2 Trial Pembrolizumab or Pembrolizumab in Combination With Intratumoral SD-101 Therapy in Patients With Hormone-Naïve Oligometastatic Prostate Cancer Receiving Stereotactic Body Radiation Therapy and Intermittent Androgen Deprivation Therapy [NCT03007732] | Phase 2 | 23 participants (Actual) | Interventional | 2017-05-17 | Active, not recruiting |
| Phase II Randomized Study Of Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide For Intermediate-High Risk Prostate Cancer Undergoing Prostatectomy [NCT02903368] | Phase 2 | 118 participants (Actual) | Interventional | 2016-10-19 | Active, not recruiting |
| BRCAAway: A Randomized Phase II Trial of Abiraterone, Olaparib, or Abiraterone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects [NCT03012321] | Phase 2 | 70 participants (Anticipated) | Interventional | 2017-01-12 | Active, not recruiting |
| A Pre-Operative Study to Assess the Effects of Abiraterone Acetate Plus LHRH Agonist and Abiraterone Acetate Plus LHRH Agonist and Enzalutamide for Six Months for Prostate Cancer Patients at High-Risk for Recurrence [NCT01946165] | Phase 2 | 69 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy. [NCT01685983] | Phase 2 | 82 participants (Actual) | Interventional | 2011-08-30 | Completed |
| A Prospective, Multi-arm, Multi-center Clinical Trial on Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer [NCT05406999] | Phase 2 | 900 participants (Anticipated) | Interventional | 2020-02-01 | Recruiting |
| A Randomized, Open Label, Single Dose, Full Replicated Crossover Study to Compare the Pharmacokinetics and Safety Between BR9004 and BR9004-1 in Healthy Male Volunteers [NCT04889651] | Phase 1 | 40 participants (Actual) | Interventional | 2021-04-15 | Completed |
| Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer: FAST Trial [NCT05223582] | Phase 2 | 34 participants (Anticipated) | Interventional | 2021-05-01 | Active, not recruiting |
| A Randomized Phase 2 Study Evaluating Abiraterone Acetate With Different Steroid Regimens for Preventing Symptoms Associated With Mineralocorticoid Excess in Asymptomatic, Chemotherapy-naïve and Metastatic Castration-resistant Prostate Cancer (mCRPC) Pati [NCT01867710] | Phase 2 | 164 participants (Actual) | Interventional | 2013-07-16 | Completed |
| A Phase 1, Single Dose, Open-Label, Three-Period, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Subjects [NCT01798628] | Phase 1 | 36 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Clinical Trial of a Rapidly Cycling, Non-Cross Reactive Regimen of Approved Therapeutic Agents to Treat Prostate Cancer [NCT02903160] | Phase 2 | 40 participants (Actual) | Interventional | 2017-01-13 | Completed |
| A Multi-Center Trial of Androgen Suppression With Abiraterone aCetate, LEuprolide, PARP Inhibition and Stereotactic Body Radiotherapy (ASCLEPIuS): A Phase I/2 Trial in High Risk and Node Positive Prostate Cancer [NCT04194554] | Phase 1/Phase 2 | 100 participants (Anticipated) | Interventional | 2020-11-06 | Recruiting |
| A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety of Zytiga (Abiraterone Acetate Tablets 250 mg) in Indian Patients With Metastatic, Castration Resistant Prostate Cancer as Per Locally Approved Prescribing Information [NCT02608359] | | 0 participants (Actual) | Observational | 2016-05-31 | Withdrawn(stopped due to No subjects recruited in the study) |
| A Randomized, Controlled, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of Prostatectomy for Castration-Naive Oligometastatic Prostate Cancer [NCT04992026] | Phase 2 | 128 participants (Anticipated) | Interventional | 2021-01-01 | Active, not recruiting |
| A 2 Arm, Phase II Controlled Randomized Trial Comparing Efficacy and Safety of Abiraterone and Abiraterone Associated With of Ablative Radiation Therapy in Patients With Oligometastatic Castration Resistant Prostate Cancer (ARTO Trial) [NCT03449719] | | 174 participants (Anticipated) | Interventional | 2018-05-01 | Not yet recruiting |
| Phase 2 Study of CJNJ-67652000 (Niraparib/Abiraterone Acetate Fixed-Dose Combination) and Prednisone for Metastatic Castration-Resistant Prostate Cancer Associated With SPOP Mutation With or Without Homologous Recombination Deficiency [NCT05689021] | Phase 2 | 30 participants (Anticipated) | Interventional | 2023-07-07 | Recruiting |
| Precision Neoadjuvant Therapy for High Risk Localized Prostate Cancer With PTEN Loss [NCT05593497] | Phase 2 | 30 participants (Anticipated) | Interventional | 2024-04-01 | Not yet recruiting |
| Phase II Trial of Primary Radiotherapy With Androgen Ablation With or Without Adjuvant Niraparib for Selected High-Risk Locoregional Prostate Cancer [NCT04947254] | Phase 2 | 200 participants (Anticipated) | Interventional | 2021-08-05 | Recruiting |
| A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair [NCT03834519] | Phase 3 | 793 participants (Actual) | Interventional | 2019-05-02 | Active, not recruiting |
| A Phase 1 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase Deficiency [NCT02574910] | Phase 1 | 36 participants (Anticipated) | Interventional | 2017-08-01 | Recruiting |
| A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Naïve Prostate Cancer [NCT01957436] | Phase 3 | 1,173 participants (Actual) | Interventional | 2013-11-13 | Active, not recruiting |
| A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy (BAT) Followed by Enzalutamide or Abiraterone Post-BAT in Men With Prostate Cancer Progressing on Combined Androgen Ablative Therapies [NCT02090114] | Phase 2 | 112 participants (Actual) | Interventional | 2014-08-25 | Completed |
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant P [NCT04691804] | Phase 3 | 804 participants (Anticipated) | Interventional | 2021-03-18 | Recruiting |
| A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have [NCT05457257] | Phase 4 | 42 participants (Anticipated) | Interventional | 2022-07-29 | Recruiting |
| A Pilot Study of Abiraterone Acetate in African American/Black Patients With Castration Resistant Prostate Cancer [NCT01735396] | Phase 2 | 11 participants (Actual) | Interventional | 2012-12-31 | Terminated(stopped due to poor accrual) |
| Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis [NCT02097303] | Phase 2 | 36 participants (Actual) | Interventional | 2014-03-31 | Completed |
| A Phase 2 Study Determining Safety and Tolerability of Enzalutamide (Formerly MDV3100) in Combination With Abiraterone Acetate in Bone Metastatic Castration-Resistant Prostate Cancer Patients [NCT01650194] | Phase 2 | 60 participants (Actual) | Interventional | 2012-07-09 | Completed |
| An Open, Multi-center, Phase Ⅱ Clinical Study of Fluzoparib Combined With Apatinib or Fluzoparib in the Treatment of Metastatic Castration-resistant Prostate Cancer [NCT04869488] | Phase 2 | 93 participants (Actual) | Interventional | 2021-07-26 | Active, not recruiting |
| A Phase II Study of Increased-Dose Abiraterone Acetate in Patients With Castration Resistant Prostate Cancer (CRPC) [NCT01637402] | Phase 2 | 41 participants (Actual) | Interventional | 2013-03-13 | Completed |
| Abiraterone Acetate in Patients With Metastatic Castration-Resistant Prostate Cancer, Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy [NCT02217566] | Phase 2 | 46 participants (Actual) | Interventional | 2014-09-23 | Completed |
| A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC) Whose Disease Has Progressed After Docetaxel Chemotherapy [NCT01511536] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2012-03-31 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00473512 (11) [back to overview] | Serum Blood Levels of Testosterone Precursors |
| NCT00473512 (11) [back to overview] | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone |
| NCT00473512 (11) [back to overview] | Serum Blood Levels of Testosterone |
| NCT00473512 (11) [back to overview] | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
| NCT00473512 (11) [back to overview] | Number of Participants With Objective Tumor Response |
| NCT00473512 (11) [back to overview] | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone |
| NCT00473512 (11) [back to overview] | Plasma Decay Half-Life (t1/2) of Abiraterone |
| NCT00473512 (11) [back to overview] | Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 |
| NCT00473512 (11) [back to overview] | Maximum Observed Plasma Concentration (Cmax) of Abiraterone |
| NCT00473512 (11) [back to overview] | Duration of Prostate Specific Antigen (PSA) Response |
| NCT00473512 (11) [back to overview] | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone |
| NCT00473746 (17) [back to overview] | Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate |
| NCT00473746 (17) [back to overview] | Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA) |
| NCT00473746 (17) [back to overview] | Phase 2: Participants With Change in Eastern Cooperative Oncology Group (ECOG) Performance Status Score |
| NCT00473746 (17) [back to overview] | Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate |
| NCT00473746 (17) [back to overview] | Phase 2: Radiographic Objective Response Rate (RAD-ORR) |
| NCT00473746 (17) [back to overview] | Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate |
| NCT00473746 (17) [back to overview] | Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate |
| NCT00473746 (17) [back to overview] | Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate |
| NCT00473746 (17) [back to overview] | Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate |
| NCT00473746 (17) [back to overview] | Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate |
| NCT00473746 (17) [back to overview] | Phase 2: Time to PSA Progression |
| NCT00473746 (17) [back to overview] | Phase 2: Radiographic Progression Free Survival (RAD-PFS) |
| NCT00473746 (17) [back to overview] | Phase 2: PSA Progression Free Survival (PSA-PFS) |
| NCT00473746 (17) [back to overview] | Phase 2: Overall Survival |
| NCT00473746 (17) [back to overview] | Phase 2: Duration of PSA Response |
| NCT00473746 (17) [back to overview] | Phase 2: Duration of Objective Response |
| NCT00473746 (17) [back to overview] | Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate |
| NCT00474383 (8) [back to overview] | Progression Free Survival Time |
| NCT00474383 (8) [back to overview] | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12 |
| NCT00474383 (8) [back to overview] | Duration of PSA Response |
| NCT00474383 (8) [back to overview] | Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148) |
| NCT00474383 (8) [back to overview] | Time to PSA Progression |
| NCT00474383 (8) [back to overview] | Overall Survival |
| NCT00474383 (8) [back to overview] | Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST) |
| NCT00474383 (8) [back to overview] | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response |
| NCT00485303 (9) [back to overview] | Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS) |
| NCT00485303 (9) [back to overview] | Time to PSA Progression |
| NCT00485303 (9) [back to overview] | Time to Radiographic Progression |
| NCT00485303 (9) [back to overview] | Percentage of Participants With Clinical Benefit |
| NCT00485303 (9) [back to overview] | Percentage of Participants With Objective Radiographic Response |
| NCT00485303 (9) [back to overview] | Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score |
| NCT00485303 (9) [back to overview] | Radiographic Progression Free Survival (PFS) |
| NCT00485303 (9) [back to overview] | Overall Survival (OS) |
| NCT00485303 (9) [back to overview] | Percentage of Participants With Prostate Specific Antigen (PSA) Response |
| NCT00544440 (2) [back to overview] | Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter) |
| NCT00544440 (2) [back to overview] | Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter) |
| NCT00638690 (4) [back to overview] | Number of Patients Achieving a Prostate-Specific Antigen Decline >=50% |
| NCT00638690 (4) [back to overview] | Overall Survival |
| NCT00638690 (4) [back to overview] | Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria |
| NCT00638690 (4) [back to overview] | Radiographic Progression-free Survival |
| NCT00887198 (7) [back to overview] | Number of Participants With Treatment Emergent Adverse Events |
| NCT00887198 (7) [back to overview] | Time to Prostate-specific Antigen (PSA) Progression |
| NCT00887198 (7) [back to overview] | Time to Opiate Use for Prostate Cancer Pain |
| NCT00887198 (7) [back to overview] | Time to Initiation of Cytotoxic Chemotherapy |
| NCT00887198 (7) [back to overview] | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point |
| NCT00887198 (7) [back to overview] | Radiographic Progression-free Survival (rPFS) |
| NCT00887198 (7) [back to overview] | Overall Survival |
| NCT01023061 (3) [back to overview] | Median Time to Prostate Specific Antigen Progression |
| NCT01023061 (3) [back to overview] | Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry |
| NCT01023061 (3) [back to overview] | Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 |
| NCT01088529 (3) [back to overview] | Number of Participants With a Positive Surgical Margin at Radical Prostatectomy |
| NCT01088529 (3) [back to overview] | Number of Participants With Prostate-Specific Antigen Response |
| NCT01088529 (3) [back to overview] | Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2) |
| NCT01199146 (3) [back to overview] | Proportion of Patients With PSA Decline of > 50% |
| NCT01199146 (3) [back to overview] | Time To Progression (TTP) |
| NCT01199146 (3) [back to overview] | Preliminary Evidence of Efficacy of Abiraterone Acetate |
| NCT01309672 (5) [back to overview] | Number of Patients With PSA Partial Response |
| NCT01309672 (5) [back to overview] | Number of Patients With Undetectable PSA |
| NCT01309672 (5) [back to overview] | Overall Survival |
| NCT01309672 (5) [back to overview] | Objective Progression-free Survival |
| NCT01309672 (5) [back to overview] | Number of Patients With Toxicity of Abiraterone Acetate |
| NCT01314118 (4) [back to overview] | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study |
| NCT01314118 (4) [back to overview] | Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment |
| NCT01314118 (4) [back to overview] | Time to Prostate-Specific Antigen (PSA) Progression |
| NCT01314118 (4) [back to overview] | Time to Radiographic Evidence of Disease Progression (TTRP) |
| NCT01381874 (7) [back to overview] | Overall Response Rate (ORR) |
| NCT01381874 (7) [back to overview] | Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment |
| NCT01381874 (7) [back to overview] | Progression-Free Survival (PFS) |
| NCT01381874 (7) [back to overview] | Clinical Benefit Rate |
| NCT01381874 (7) [back to overview] | Duration of Response |
| NCT01381874 (7) [back to overview] | Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment |
| NCT01381874 (7) [back to overview] | Overall Survival (OS) |
| NCT01393730 (8) [back to overview] | Prostate-Specific Antigen (PSA) Response |
| NCT01393730 (8) [back to overview] | Time to Progression (TTP) |
| NCT01393730 (8) [back to overview] | Change in Serum Androgen Levels |
| NCT01393730 (8) [back to overview] | Time to PSA Progression |
| NCT01393730 (8) [back to overview] | Presence of AR Amplification |
| NCT01393730 (8) [back to overview] | Change in Serum Levels of Testosterone |
| NCT01393730 (8) [back to overview] | Number of Participants With Androgen Receptor (AR) Related Mutations |
| NCT01393730 (8) [back to overview] | Best Overall Response |
| NCT01487863 (1) [back to overview] | Cumulative CD54 Upregulation Ratio Between the Cohorts. |
| NCT01503229 (1) [back to overview] | Change in Tissue Testosterone and Dihydrotestosterone |
| NCT01511536 (15) [back to overview] | Phase 2: Objective Progression Free Survival (PFS) |
| NCT01511536 (15) [back to overview] | Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate |
| NCT01511536 (15) [back to overview] | Phase 2: PSA Progression Free Survival |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss) |
| NCT01511536 (15) [back to overview] | Phase 2: Percentage of Participants With Objective Response |
| NCT01511536 (15) [back to overview] | Phase 2: Overall Survival |
| NCT01511536 (15) [back to overview] | Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24) |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss) |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax) |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax) |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC) |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax) |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z) |
| NCT01511536 (15) [back to overview] | Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL) |
| NCT01517802 (1) [back to overview] | Number of Participants With Serious Adverse Events (SAEs) |
| NCT01543776 (5) [back to overview] | Progression-free Survival (PFS) |
| NCT01543776 (5) [back to overview] | Peak Plasma Concentration of Abiraterone |
| NCT01543776 (5) [back to overview] | Adrenal Androgen Production (DHEA-S) |
| NCT01543776 (5) [back to overview] | Change in PSA Level |
| NCT01543776 (5) [back to overview] | Number of Participants With Adverse Events (AEs) |
| NCT01576172 (5) [back to overview] | Rates of PSA Decline |
| NCT01576172 (5) [back to overview] | Progression-free Survival (PFS) |
| NCT01576172 (5) [back to overview] | Objective Response Rates in Patients With Measurable Disease. |
| NCT01576172 (5) [back to overview] | Confirmed Prostate-specific Antigen (PSA) Response Rate |
| NCT01576172 (5) [back to overview] | Grade 4 or 5 Adverse Events |
| NCT01637402 (9) [back to overview] | Comparison of Circulating Androstenedione Levels Between Primary-Resistant Patients and Responders |
| NCT01637402 (9) [back to overview] | Time to PSA Progression for Dose Escalation Cohort |
| NCT01637402 (9) [back to overview] | Number of Participants With Worst-grade, Treatment-related Toxicities for Dose Escalation Group |
| NCT01637402 (9) [back to overview] | Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders |
| NCT01637402 (9) [back to overview] | Serum Concentration Levels of Abiraterone Acetate Over Time |
| NCT01637402 (9) [back to overview] | Number of Patients With PSA Response From Dose Escalation |
| NCT01637402 (9) [back to overview] | Correlation of Circulating Dehydroepiandrosterone (DHEA) Levels From Baseline to Week 12 |
| NCT01637402 (9) [back to overview] | Comparison of Circulating Testosterone Levels Between Primary-Resistant Patients and Responders |
| NCT01637402 (9) [back to overview] | Comparison of Circulating DHEA-S Levels Between Primary-Resistant Patients and Responders |
| NCT01650194 (17) [back to overview] | Change From Baseline in Androstenedione Concentration in Blood |
| NCT01650194 (17) [back to overview] | Bone Scan Response at EoT |
| NCT01650194 (17) [back to overview] | Change From Baseline in Cortisol in Bone Marrow Aspirate |
| NCT01650194 (17) [back to overview] | Change From Baseline in Pregnenolone Concentration in Blood |
| NCT01650194 (17) [back to overview] | Change From Baseline in Pregnenolone in Bone Marrow Aspirate |
| NCT01650194 (17) [back to overview] | Change From Baseline in Androstenedione in Bone Marrow Aspirate |
| NCT01650194 (17) [back to overview] | Change From Baseline in Progesterone Concentration in Blood |
| NCT01650194 (17) [back to overview] | Change From Baseline in Progesterone in Bone Marrow Aspirate |
| NCT01650194 (17) [back to overview] | Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels |
| NCT01650194 (17) [back to overview] | Change From Baseline in Testosterone Concentration in Blood |
| NCT01650194 (17) [back to overview] | Change From Baseline in Cortisol Concentration in Blood |
| NCT01650194 (17) [back to overview] | Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate |
| NCT01650194 (17) [back to overview] | Change From Baseline in Urine N-Telopeptide |
| NCT01650194 (17) [back to overview] | Change From Baseline to EoT in Bone Specific Alkaline Phosphatase |
| NCT01650194 (17) [back to overview] | Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) |
| NCT01650194 (17) [back to overview] | Progression Free Survival (PFS) |
| NCT01650194 (17) [back to overview] | Number of Participants With Adverse Events (AEs) |
| NCT01681433 (5) [back to overview] | Circulating Tumor Cell (CTC) Counts |
| NCT01681433 (5) [back to overview] | Objective Response |
| NCT01681433 (5) [back to overview] | PSA Response |
| NCT01681433 (5) [back to overview] | Time to Disease Progression |
| NCT01681433 (5) [back to overview] | Progression-Free Survival |
| NCT01685983 (7) [back to overview] | Time to PSA Progression |
| NCT01685983 (7) [back to overview] | Percentage of Participants With Prostate-specific Antigen (PSA) Response |
| NCT01685983 (7) [back to overview] | Percentage of Participants With Objective Radiographic Response |
| NCT01685983 (7) [back to overview] | Overall Survival |
| NCT01685983 (7) [back to overview] | Serum Testosterone |
| NCT01685983 (7) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT01685983 (7) [back to overview] | Dehydroepiandrosterone Sulfate (DHEA-S) |
| NCT01695135 (8) [back to overview] | DB Phase: Overall Survival |
| NCT01695135 (8) [back to overview] | DB Phase: Percentage of Participants Who Achieved PSA Response |
| NCT01695135 (8) [back to overview] | DB Phase: Percentage of Participants Experiencing Pain Palliation |
| NCT01695135 (8) [back to overview] | DB Phase: Time to Pain Progression |
| NCT01695135 (8) [back to overview] | DB Phase: Time to Prostate-Specific Antigen Progression (PSA) |
| NCT01695135 (8) [back to overview] | DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment |
| NCT01695135 (8) [back to overview] | DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment |
| NCT01695135 (8) [back to overview] | DB Phase: Objective Response Rate (ORR) |
| NCT01715285 (7) [back to overview] | Time to Initiation of Chemotherapy |
| NCT01715285 (7) [back to overview] | Overall Survival (OS) |
| NCT01715285 (7) [back to overview] | Radiographic Progression-Free Survival (PFS) |
| NCT01715285 (7) [back to overview] | Time to Pain Progression |
| NCT01715285 (7) [back to overview] | Time to Prostate-Specific Antigen (PSA) Progression |
| NCT01715285 (7) [back to overview] | Time to Skeletal-Related Event |
| NCT01715285 (7) [back to overview] | Time to Subsequent Therapy for Prostate Cancer |
| NCT01717053 (8) [back to overview] | Metastasis or Systemic Therapy |
| NCT01717053 (8) [back to overview] | Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year |
| NCT01717053 (8) [back to overview] | PSA Nadir Value |
| NCT01717053 (8) [back to overview] | PSA < 1.5ng/ml in Setting of Non-castrate Testosterone |
| NCT01717053 (8) [back to overview] | Percentage of Participants With Biochemical Progression-free Survival (BPFS) |
| NCT01717053 (8) [back to overview] | Time to PSA Nadir |
| NCT01717053 (8) [back to overview] | Testosterone Recovery |
| NCT01717053 (8) [back to overview] | Safety and Tolerability |
| NCT01717898 (3) [back to overview] | Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I). |
| NCT01717898 (3) [back to overview] | Anti-tumor Responses as Defined by a Decline in PSA of > 50% |
| NCT01717898 (3) [back to overview] | Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I). |
| NCT01735396 (3) [back to overview] | Number of Participants With ≥ 30% Change in PSA |
| NCT01735396 (3) [back to overview] | Response Assessment |
| NCT01735396 (3) [back to overview] | Safety of Abiraterone |
| NCT01751451 (1) [back to overview] | Progression-free Survival (PFS) |
| NCT01845792 (2) [back to overview] | Progression-Free Survival |
| NCT01845792 (2) [back to overview] | PSA Response |
| NCT01848067 (2) [back to overview] | Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1 |
| NCT01848067 (2) [back to overview] | Number of Participants With a PSA Value Equal to or Greater Than 25% |
| NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Worst Pain |
| NCT01867710 (15) [back to overview] | Time to Opiate Use for Cancer-related Pain |
| NCT01867710 (15) [back to overview] | Time to Prostate-Specific Antigen (PSA) Progression |
| NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score |
| NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Interference Subscale |
| NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in Brief Pain Inventory- Short Form (BPI-SF) Score: Pain Intensity Subscale |
| NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS |
| NCT01867710 (15) [back to overview] | Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score |
| NCT01867710 (15) [back to overview] | Objective Response Rate (ORR) |
| NCT01867710 (15) [back to overview] | Overall Survival |
| NCT01867710 (15) [back to overview] | Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment |
| NCT01867710 (15) [back to overview] | Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12 |
| NCT01867710 (15) [back to overview] | Progression-Free Survival (PFS) |
| NCT01867710 (15) [back to overview] | Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by 1 Point |
| NCT01867710 (15) [back to overview] | Time to Next Prostate Cancer Therapy |
| NCT01940276 (6) [back to overview] | Percent of Subjects Experiencing Hypertension |
| NCT01940276 (6) [back to overview] | Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml |
| NCT01940276 (6) [back to overview] | Change in PSA Response |
| NCT01940276 (6) [back to overview] | Overall Survival |
| NCT01940276 (6) [back to overview] | Median Time to PSA Progression |
| NCT01940276 (6) [back to overview] | Median Radiographic Progression Free Survival (PFS) |
| NCT01946165 (2) [back to overview] | Proportion of Participants With Positive Surgical Margins |
| NCT01946165 (2) [back to overview] | Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0 |
| NCT01994590 (1) [back to overview] | Safety and Tolerability |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores |
| NCT01995513 (27) [back to overview] | Objective Response Rate (ORR) |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores |
| NCT01995513 (27) [back to overview] | Time to Prostate Specific Antigen (PSA) Progression |
| NCT01995513 (27) [back to overview] | Time to First Use of New Antineoplastic Therapy for Prostate Cancer |
| NCT01995513 (27) [back to overview] | Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
| NCT01995513 (27) [back to overview] | Rate of Pain Progression |
| NCT01995513 (27) [back to overview] | Progression Free Survival (PFS) |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Death |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score |
| NCT01995513 (27) [back to overview] | Prostate Specific Antigen (PSA) Response Rate |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation |
| NCT01995513 (27) [back to overview] | Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores |
| NCT01995513 (27) [back to overview] | Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores |
| NCT02025010 (11) [back to overview] | Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess |
| NCT02025010 (11) [back to overview] | Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2. |
| NCT02025010 (11) [back to overview] | Changes in Serum Concentrations of Corticosteroid Intermediates Between the First and Second Assessment Visits. |
| NCT02025010 (11) [back to overview] | Changes in BMI Between Cycle 1 and Next Cycle |
| NCT02025010 (11) [back to overview] | Changes in Hemoglobin-A1c Between Cycle 1 and Next Cycle (Cycle 4) |
| NCT02025010 (11) [back to overview] | Changes in Serum Concentrations of ACTH Between Cycle 1 and Cycle 2. |
| NCT02025010 (11) [back to overview] | Number of Participants Requiring the Addition of Prednisone to Manage Symptoms of Severe Fatigue. |
| NCT02025010 (11) [back to overview] | Number of Patients Who Progressed With Measurable Disease at Pre-study Among Those Who Were Added of Prednisone to AA at Time of PSA Progression on AA Monotherapy. |
| NCT02025010 (11) [back to overview] | Number of Patients Who Received AA Monotherapy and Progressed With Measurable Disease at Pre-study |
| NCT02025010 (11) [back to overview] | PSA Response and Its Duration to AA Monotherapy. |
| NCT02025010 (11) [back to overview] | PSA Response and Its Duration to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy. |
| NCT02034552 (8) [back to overview] | Symptomatic Skeletal Event-free Survival |
| NCT02034552 (8) [back to overview] | Time to First Symptomatic Skeletal Event |
| NCT02034552 (8) [back to overview] | Time to Radiological Bone Progression |
| NCT02034552 (8) [back to overview] | Time to Radiological Progression |
| NCT02034552 (8) [back to overview] | Patient Bone Scan Response Rate |
| NCT02034552 (8) [back to overview] | Radiological Progression Free Survival |
| NCT02034552 (8) [back to overview] | Overall Survival |
| NCT02034552 (8) [back to overview] | Bone Scan Lesion Area |
| NCT02090114 (10) [back to overview] | Disease Response as Defined by RECIST 1.1 (Soft Tissue Lesions) and PCWG2 Criteria (Bone Lesions) |
| NCT02090114 (10) [back to overview] | PSA Progression on Enzalutamide or Abiraterone Acetate or Castrate Levels Post-BAT |
| NCT02090114 (10) [back to overview] | Safety and Tolerability as Assessed by Number of Participants With Adverse Events |
| NCT02090114 (10) [back to overview] | PSA Progression on BAT (Bipolar Androgen Therapy ) |
| NCT02090114 (10) [back to overview] | Quality of Life (QoL) as Assessed by IIEF |
| NCT02090114 (10) [back to overview] | Quality of Life (QoL) as Assessed by RANDSF-36 |
| NCT02090114 (10) [back to overview] | Quality of Life (QoL) as Assessed by FACIT-F Score |
| NCT02090114 (10) [back to overview] | Quality of Life (QoL) as Assessed by PANAS |
| NCT02090114 (10) [back to overview] | Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy (BAT) |
| NCT02090114 (10) [back to overview] | PSA Response to Enzalutamide or Abiraterone Acetate Post Bipolar Androgen Therapy |
| NCT02097303 (7) [back to overview] | Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment |
| NCT02097303 (7) [back to overview] | Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported. |
| NCT02097303 (7) [back to overview] | Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment) |
| NCT02097303 (7) [back to overview] | Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment |
| NCT02097303 (7) [back to overview] | Bone Imaging Response (Number of Participants With Progression and Stable Disease) |
| NCT02097303 (7) [back to overview] | Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria |
| NCT02097303 (7) [back to overview] | Overall Response Rate |
| NCT02217566 (6) [back to overview] | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT02217566 (6) [back to overview] | Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Severity Score |
| NCT02217566 (6) [back to overview] | Percentage of Participants With Pain Progression as Assessed by Brief Pain Inventory - Short Form (BPI-SF) - Pain Interference Score |
| NCT02217566 (6) [back to overview] | Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response |
| NCT02217566 (6) [back to overview] | Overall Survival |
| NCT02217566 (6) [back to overview] | Time to Prostate-specific Antigen (PSA) Progression |
| NCT02257736 (5) [back to overview] | Time to Chronic Opioid Use |
| NCT02257736 (5) [back to overview] | Time to Initiation of Cytotoxic Chemotherapy |
| NCT02257736 (5) [back to overview] | Time to Pain Progression |
| NCT02257736 (5) [back to overview] | Overall Survival (OS) |
| NCT02257736 (5) [back to overview] | Radiographic Progression-free Survival (rPFS) |
| NCT02268175 (4) [back to overview] | Residual Cancer Burden (RCB) |
| NCT02268175 (4) [back to overview] | Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD) |
| NCT02268175 (4) [back to overview] | Participants With Pathologic Complete Response (pCR) |
| NCT02268175 (4) [back to overview] | Median Prostate Specific Antigen (PSA) Nadir |
| NCT02485691 (14) [back to overview] | Overall Survival (OS) |
| NCT02485691 (14) [back to overview] | Number of Symptomatic Skeletal Events (SSE) |
| NCT02485691 (14) [back to overview] | Duration of Tumor Response |
| NCT02485691 (14) [back to overview] | Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment |
| NCT02485691 (14) [back to overview] | Time to Pain Progression |
| NCT02485691 (14) [back to overview] | Radiographic Progression-Free Survival (rPFS) |
| NCT02485691 (14) [back to overview] | Progression Free Survival (PFS) |
| NCT02485691 (14) [back to overview] | Percentage of Participants With Prostate Specific Antigen (PSA) Response |
| NCT02485691 (14) [back to overview] | Percentage of Participants With Overall Objective Tumor Response |
| NCT02485691 (14) [back to overview] | Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker |
| NCT02485691 (14) [back to overview] | Health-Related Quality of Life (HRQOL): Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment |
| NCT02485691 (14) [back to overview] | Percentage of Participants Achieving Pain Response Assessed Using Brief Pain Inventory-Short Form (BPI-SF) Pain Intensity Score |
| NCT02485691 (14) [back to overview] | Time to Symptomatic Skeletal Event |
| NCT02485691 (14) [back to overview] | Time to PSA Progression (TTPP) |
| NCT02737332 (9) [back to overview] | AUC (0-24 hr) |
| NCT02737332 (9) [back to overview] | Cmax |
| NCT02737332 (9) [back to overview] | Testosterone Levels |
| NCT02737332 (9) [back to overview] | Percent of Subjects With PSA-50 Response |
| NCT02737332 (9) [back to overview] | PSA Levels |
| NCT02737332 (9) [back to overview] | Serum Testosterone Levels |
| NCT02737332 (9) [back to overview] | Steady State Trough Concentration of Arbiraterone |
| NCT02737332 (9) [back to overview] | AUC (0-inf) |
| NCT02737332 (9) [back to overview] | AUC (0-t) |
| NCT02849990 (7) [back to overview] | Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment |
| NCT02849990 (7) [back to overview] | Overall Survival (OS) |
| NCT02849990 (7) [back to overview] | Number of Patients With Pathologic T3 Disease After 3 Months of Treatment. |
| NCT02849990 (7) [back to overview] | Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment |
| NCT02849990 (7) [back to overview] | Number of Participants Without Biochemical Failure at 2 Years |
| NCT02849990 (7) [back to overview] | Number of Patients With no Nodal Metastases After 3 Months of Treatment. |
| NCT02849990 (7) [back to overview] | The Proportion of Men Who Receive Adjuvant Radiation Therapy |
| NCT02903368 (17) [back to overview] | Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2) |
| NCT02903368 (17) [back to overview] | Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2] |
| NCT02903368 (17) [back to overview] | Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2] |
| NCT02903368 (17) [back to overview] | Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2] |
| NCT02903368 (17) [back to overview] | Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2) |
| NCT02903368 (17) [back to overview] | Frequency of Positive Surgical Margins at RP (Part 1) |
| NCT02903368 (17) [back to overview] | Frequency of Presenting Cribriform at RP (Part 1) |
| NCT02903368 (17) [back to overview] | Frequency of Presenting Intra-operative Complications Following RP (Part 1) |
| NCT02903368 (17) [back to overview] | Frequency of Presenting Intraductal Carcinoma at RP (Part 1) |
| NCT02903368 (17) [back to overview] | Median of Residual Cancer Burden (RCB) at RP (Part 1) |
| NCT02903368 (17) [back to overview] | Combined pCR or MRD Rate [Part 1] |
| NCT02903368 (17) [back to overview] | Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2) |
| NCT02903368 (17) [back to overview] | Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2) |
| NCT02903368 (17) [back to overview] | Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1) |
| NCT02903368 (17) [back to overview] | Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2) |
| NCT02903368 (17) [back to overview] | Rate of pCR at RP (Part 1) |
| NCT02903368 (17) [back to overview] | Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2) |
| NCT02962284 (6) [back to overview] | Testosterone Levels |
| NCT02962284 (6) [back to overview] | Testosterone Complete Suppression |
| NCT02962284 (6) [back to overview] | Prostate Specific Antigen Levels |
| NCT02962284 (6) [back to overview] | Proportion of Subjects With Disease Progression |
| NCT02962284 (6) [back to overview] | Number of Subjects With Adverse Events |
| NCT02962284 (6) [back to overview] | Percentage of Subjects With Prostate Specific Antigen - 50 Response |
| NCT02975934 (18) [back to overview] | PSA Response in Participants With a BRCA or ATM Alteration Combined |
| NCT02975934 (18) [back to overview] | Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration |
| NCT02975934 (18) [back to overview] | Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined |
| NCT02975934 (18) [back to overview] | Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration |
| NCT02975934 (18) [back to overview] | Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined |
| NCT02975934 (18) [back to overview] | Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling |
| NCT02975934 (18) [back to overview] | Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF |
| NCT02975934 (18) [back to overview] | Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration |
| NCT02975934 (18) [back to overview] | Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L |
| NCT02975934 (18) [back to overview] | Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined |
| NCT02975934 (18) [back to overview] | Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration |
| NCT02975934 (18) [back to overview] | Interim Overall Survival in Participants With a BRCA or ATM Alteration Combined |
| NCT02975934 (18) [back to overview] | Interim Overall Survival in Participants With a BRCA Alteration |
| NCT02975934 (18) [back to overview] | Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined |
| NCT02975934 (18) [back to overview] | Duration of Response (DOR) by IRR in Participants With a BRCA Alteration |
| NCT02975934 (18) [back to overview] | Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined |
| NCT02975934 (18) [back to overview] | Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P |
| NCT02975934 (18) [back to overview] | PSA Response in Participants With a BRCA Alteration |
| NCT02987543 (3) [back to overview] | Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only |
| NCT02987543 (3) [back to overview] | Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B |
| NCT02987543 (3) [back to overview] | Time to Pain Progression - Cohort A Only |
| NCT03043807 (1) [back to overview] | Time to Prostate-specific Antigen Recurrence |
| NCT03279250 (2) [back to overview] | Number of Participants With Incidence of Adverse Events |
| NCT03279250 (2) [back to overview] | The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy |
| NCT03431350 (11) [back to overview] | Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity |
| NCT03431350 (11) [back to overview] | Combination 1: Part 1: Number of Participants With Specified Toxicity |
| NCT03431350 (11) [back to overview] | Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose |
| NCT03431350 (11) [back to overview] | Combination 1: Part 2: Number of Participants With Adverse Events (AEs) |
| NCT03431350 (11) [back to overview] | Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose |
| NCT03431350 (11) [back to overview] | Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose |
| NCT03431350 (11) [back to overview] | Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose |
| NCT03431350 (11) [back to overview] | Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity |
| NCT03431350 (11) [back to overview] | Combination 2: Number of Participants With Adverse Events (AEs) |
| NCT03431350 (11) [back to overview] | Combination 2: Composite Response Rate (RR) |
| NCT03431350 (11) [back to overview] | Combination 1: Part 2: Objective Response Rate (ORR) |
| NCT03649841 (2) [back to overview] | Incidence of Adverse Events |
| NCT03649841 (2) [back to overview] | Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2) |
| NCT03732820 (9) [back to overview] | Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P) |
| NCT03732820 (9) [back to overview] | Number of Participants With First Symptomatic Skeletal Related Event (SSRE) |
| NCT03732820 (9) [back to overview] | Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment |
| NCT03732820 (9) [back to overview] | Number of Participants With Second Progression or Death (PFS2) Event |
| NCT03732820 (9) [back to overview] | Number of Participants With Time to First Subsequent Anticancer Therapy or Death (TFST) Event |
| NCT03732820 (9) [back to overview] | Number of Participants With Time to Pain Progression (TTPP) Event |
| NCT03732820 (9) [back to overview] | Brief Pain Inventory-Short Form (BPI-SF) |
| NCT03732820 (9) [back to overview] | Number of Participants With Opiate Use |
| NCT03732820 (9) [back to overview] | Number of Participants With Overall Survival (OS) Event |
| NCT03748641 (1) [back to overview] | Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR) |
| NCT03827473 (5) [back to overview] | Change in Quality of Life - FACT/GOG-NTX |
| NCT03827473 (5) [back to overview] | Change in Quality of Life - PROMIS Fatigue |
| NCT03827473 (5) [back to overview] | Prostate Specific Antigen Progression Free Survival (PSA-PFS) |
| NCT03827473 (5) [back to overview] | Prostate-specific Antigen (PSA) Response |
| NCT03827473 (5) [back to overview] | Change in Quality of Life - FACT-P |
| NCT03834519 (2) [back to overview] | Overall Survival (OS) |
| NCT03834519 (2) [back to overview] | Radiographic Progression-Free Survival (rPFS) |
| NCT03999515 (6) [back to overview] | Incidence and Severity of Adverse Events (AEs) |
| NCT03999515 (6) [back to overview] | Time to Response |
| NCT03999515 (6) [back to overview] | Radiographic Progression Free Survival (PFS) |
| NCT03999515 (6) [back to overview] | Objective Response Rate |
| NCT03999515 (6) [back to overview] | Prostate-specific Antigen (PSA) Response |
| NCT03999515 (6) [back to overview] | Overall Survival (OS) |
Serum Blood Levels of Testosterone Precursors
Concentration of Cortisol, Aldosterone, Corticosterone, 11-Deoxycortisol, Deoxycorticosterone and Dehydroepiandrostenedione Sulphate (DHEA-S) in blood was measured in nanogram per deciliter (ng/dL). (NCT00473512)
Timeframe: Baseline, Cycle 2 (within 3 days prior to Day 29)
| Intervention | ng/dL (Median) |
|---|
| Cortisol; Baseline (n = 33) | Cortisol; Cycle 2 (n = 29) | Aldosterone; Baseline (n=33) | Aldosterone; Cycle 2 (n=29) | Corticosterone; Baseline (n=33) | Corticosterone; Cycle 2 (n=27) | 11-Deoxycortisol; Baseline (n=31) | 11-Deoxycortisol; Cycle 2 (n=25) | Deoxycorticosterone; Baseline (n=32) | Deoxycorticosterone; Cycle 2 (n=28) | DHEA-S; Baseline (n=32) | DHEA-S; Cycle 2 (n=28) |
|---|
| 1000 mg AA Therapy | 12000 | 4000 | 8 | 8 | 193 | 6797 | 39 | 73 | 6 | 121 | 30000 | 15000 |
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Abiraterone
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). (NCT00473512)
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given
| Intervention | hours*nmol/L (Mean) |
|---|
| Abiraterone Acetate 250 mg | 1369 |
| Abiraterone Acetate 500 mg | 1448 |
| Abiraterone Acetate 750 mg | 4537 |
| Abiraterone Acetate 1000 mg | 4615 |
| Abiraterone Acetate 2000 mg | 4983 |
Serum Blood Levels of Testosterone
Concentration of testosterone in blood was measured in nanogram per deciliter (ng/dL). (NCT00473512)
Timeframe: Baseline, Cycle 2 (within 3 days prior to Day 29)
| Intervention | ng/dL (Median) |
|---|
| Baseline (n = 23) | Cycle 2 (n = 28) |
|---|
| 1000 mg AA Therapy | 3 | 1 |
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. (NCT00473512)
Timeframe: Baseline up to 30 days after the last dose of study medication
| Intervention | participants (Number) |
|---|
| AEs | SAEs |
|---|
| 1000 mg/Day | 41 | 20 |
,| 2000 mg/Day | 3 | 2 |
,| 250 mg/Day | 3 | 2 |
,| 500 mg/Day | 3 | 2 |
,| 750 mg/Day | 3 | 0 |
Number of Participants With Objective Tumor Response
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. (NCT00473512)
Timeframe: Baseline up to end of study (1160 days)
| Intervention | Participants (Number) |
|---|
| Complete response | Partial response |
|---|
| 1000 mg AA Therapy | 0 | 8 |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone
The Tmax is defined as actual sampling time to reach maximum observed plasma concentration. The analyte concentration associated with Tmax is referred to as Cmax. (NCT00473512)
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given
| Intervention | hours (Mean) |
|---|
| Abiraterone Acetate 250 mg | 2.050 |
| Abiraterone Acetate 500 mg | 2.588 |
| Abiraterone Acetate 750 mg | 1.709 |
| Abiraterone Acetate 1000 mg | 3.159 |
| Abiraterone Acetate 2000 mg | 2.672 |
Plasma Decay Half-Life (t1/2) of Abiraterone
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. (NCT00473512)
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given
| Intervention | hour (Mean) |
|---|
| Abiraterone Acetate 250 mg | 11.6 |
| Abiraterone Acetate 500 mg | 9.5 |
| Abiraterone Acetate 750 mg | 10.8 |
| Abiraterone Acetate 1000 mg | 10.6 |
| Abiraterone Acetate 2000 mg | 12.0 |
Number of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
The PSA response was measured according to PSA working group (PSAWG) criteria. All participants achieving a fall in PSA of greater than 50 percent from baseline, which has been confirmed by a second measurement at least 4 weeks after initial documentation, fulfill criteria for confirmed PSA response. (NCT00473512)
Timeframe: Baseline, Week 12
| Intervention | Participants (Number) |
|---|
| 1000 mg AA Monotherapy | 10 |
| 1000 mg AA Therapy | 25 |
Maximum Observed Plasma Concentration (Cmax) of Abiraterone
The Cmax is defined as maximum observed analyte concentration. (NCT00473512)
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given
| Intervention | nmol/L (Mean) |
|---|
| Abiraterone Acetate 250 mg | 219 |
| Abiraterone Acetate 500 mg | 284 |
| Abiraterone Acetate 750 mg | 1032 |
| Abiraterone Acetate 1000 mg | 571 |
| Abiraterone Acetate 2000 mg | 531 |
Duration of Prostate Specific Antigen (PSA) Response
Duration of PSA response in participants on abiraterone acetate therapy was measured as the duration between PSA 50 percent decline date and PSA progression date as defined by the PSAWG criteria. (NCT00473512)
Timeframe: Baseline up to end of study (1160 days)
| Intervention | Days (Median) |
|---|
| 1000 mg AA Therapy | 141 |
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Abiraterone
Area under the plasma concentration time-curve from time zero to the last quantifiable concentration (AUClast). (NCT00473512)
Timeframe: Pre-dose on Day 1, 8 and 15 of Cycle 1, Day 1 of Cycle 2, Day 1 of Cycle 3; 1, 2, 4, 6, 8, 24, 48 and 72 hours after first dose was given
| Intervention | hours*nmol/L (Mean) |
|---|
| Abiraterone Acetate 250 mg | 1253 |
| Abiraterone Acetate 500 mg | 1334 |
| Abiraterone Acetate 750 mg | 4294 |
| Abiraterone Acetate 1000 mg | 4371 |
| Abiraterone Acetate 2000 mg | 4754 |
Phase 1: Total Body Clearance (Cl_F_obs) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
| Intervention | liter per hour (l/hr) (Mean) |
|---|
| Fasted | Fed |
|---|
| Phase I Dose Escalation (1000mg) | 2649.954 | 231.383 |
,| Phase I Dose Escalation (250mg) | 4288.456 | 529.606 |
,| Phase I Dose Escalation (500mg) | 5440.949 | 391.046 |
,| Phase I Dose Escalation (750mg) | 1518.748 | 246.643 |
Phase 2: Participants With Greater Than or Equal to 50 Percent Decline in Prostate Specific Antigen (PSA)
Number of participants with greater than or equal to 50 percent decrease in PSA levels were assessed. PSA decline was evaluated according to (Prostate Specific Antigen Working Group) PSAWG criteria. Decrease in PSA levels represented improvement. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
| Intervention | participants (Number) |
|---|
| Confirmed | Not Confirmed | Total |
|---|
| Phase II Dose Treatment | 26 | 2 | 28 |
Phase 1: Volume of Distribution (Vz_F_obs) of Abiraterone Acetate
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Volume of distribution is normally calculated by using equation volume of distribution =dose/initial concentration. Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
| Intervention | Liter (L) (Mean) |
|---|
| Fasted | Fed |
|---|
| Phase I Dose Escalation (1000mg) | 25494.398 | 4068.885 |
,| Phase I Dose Escalation (250mg) | 653.745 | 3940.400 |
,| Phase I Dose Escalation (500mg) | 10252.077 | 3418.280 |
,| Phase I Dose Escalation (750mg) | 13688.367 | 2739.655 |
Phase 2: Radiographic Objective Response Rate (RAD-ORR)
The objective response rate is defined as the proportion of participants with measurable lesions achieving a Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
| Intervention | participants (Number) |
|---|
| Confirmed | Not Confirmed |
|---|
| Phase II Dose Treatment | 9 | 1 |
Phase 1: Time to Reach the Maximum Plasma Concentration (Tmax) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose) (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
| Intervention | hour (hr) (Mean) |
|---|
| Fasted | Fed |
|---|
| Phase I Dose Escalation (1000mg) | 1.833 | 4.000 |
,| Phase I Dose Escalation (250mg) | 2.000 | 2.044 |
,| Phase I Dose Escalation (500mg) | 1.500 | 2.667 |
,| Phase I Dose Escalation (750mg) | 2.033 | 2.000 |
Phase 1: Terminal Half-life (HL_Lambda_z) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
| Intervention | hour (hr) (Mean) |
|---|
| Fasted | Fed |
|---|
| Phase I Dose Escalation (1000mg) | 14.361 | 12.454 |
,| Phase I Dose Escalation (250mg) | 5.284 | 5.125 |
,| Phase I Dose Escalation (500mg) | 10.591 | 6.913 |
,| Phase I Dose Escalation (750mg) | 7.066 | 7.939 |
Phase 1: Maximum Plasma Concentration (Cmax) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3.
| Intervention | nanomoles per liter (nmol/L) (Mean) |
|---|
| Fasted | Fed |
|---|
| Phase I Dose Escalation (1000mg) | 509.500 | 2194.250 |
,| Phase I Dose Escalation (250mg) | 283.000 | 421.000 |
,| Phase I Dose Escalation (500mg) | 330.633 | 676.000 |
,| Phase I Dose Escalation (750mg) | 289.533 | 1552.000 |
Phase 1: Area Under the Plasma-Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
| Intervention | hr*nmol/L (Mean) |
|---|
| Fasted | Fed |
|---|
| Phase I Dose Escalation (1000mg) | 3039.937 | 13695.482 |
,| Phase I Dose Escalation (250mg) | 1329.178 | 1310.715 |
,| Phase I Dose Escalation (500mg) | 1625.059 | 3624.781 |
,| Phase I Dose Escalation (750mg) | 1565.659 | 8920.790 |
Phase 1: Area Under the Plasma-Concentration-time Curve From Time 0 to Infinite Time (AUCINF_obs) of Abiraterone Acetate
Blood samples for pharmacokinetic (PK) measurements was taken on Day -7 at hour 0 (predose), at hours 1, 2, 4, 6, 8, and 12 (postdose). On Day -6 at 24 hour (postdose) and Day -5 at 48 hour (postdose). On Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 2 and 3 (Predose). (NCT00473746)
Timeframe: At hours 1, 2, 4, 6, 8, 12, 24 and 48 post dose and pre-dose on day 1, day 8, day 15 and day 22 cycle 1, day 1 cycle 2 and day 1 cycle 3
| Intervention | hr*nmol/L (Mean) |
|---|
| Fasted | Fed |
|---|
| Phase I Dose Escalation (1000mg) | 3478.385 | 14404.387 |
,| Phase I Dose Escalation (250mg) | 1411.268 | 1386.939 |
,| Phase I Dose Escalation (500mg) | 1781.374 | 3839.804 |
,| Phase I Dose Escalation (750mg) | 1665.454 | 9358.743 |
Phase 2: Time to PSA Progression
The time interval from the date of first dose of abiraterone acetate therapy to the date of the PSA progression as defined by the PSAWG criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
| Intervention | days (Median) |
|---|
| Phase II Dose Treatment | 497 |
Phase 2: Radiographic Progression Free Survival (RAD-PFS)
RAD-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or radiographic disease progression according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
| Intervention | days (Median) |
|---|
| Phase II Dose Treatment | NA |
Phase 2: PSA Progression Free Survival (PSA-PFS)
PSA-PFS is the time interval from the date of first dose of abiraterone acetate therapy to the date of death or the PSA progression as defined by the Prostate Specific Antigen Working Group (PSAWG) criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
| Intervention | days (Median) |
|---|
| Phase II Dose Treatment | 473 |
Phase 2: Overall Survival
Overall survival is the time interval from the date of first dose (cycle 1 day 1) of abiraterone acetate therapy to the date of death from any cause. (NCT00473746)
Timeframe: Up to Month 60
| Intervention | days (Median) |
|---|
| Phase II Dose Treatment | NA |
Phase 2: Duration of PSA Response
Duration of PSA response was defined as the duration between the date of confirmed PSA response and subsequent PSA progression date as defined by the PSAWG criteria. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
| Intervention | days (Median) |
|---|
| Phase II Dose Treatment | 477 |
Phase 2: Duration of Objective Response
Duration of objective response was assessed only in participants who achieved a CR or PR, and measured from the first documented date of response to the first documented date of disease progression according to the RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00473746)
Timeframe: Up to 12 weeks from start of treatment
| Intervention | days (Median) |
|---|
| Phase II Dose Treatment | NA |
Phase 1: Maximum Tolerated Dose (MTD) of Abiraterone Acetate
The MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects. (NCT00473746)
Timeframe: Up to Cycle 12
| Intervention | mg/day (Number) |
|---|
| Phase I Dose Escalation | NA |
Progression Free Survival Time
Progression Free Survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death or date of progressive disease (PD) as assessed by RECIST criteria. PD was at least 20 percent increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT00474383)
Timeframe: Baseline until first documented disease progression or death or up to end of study (Week 148; assessed on Day 1 of each cycle)
| Intervention | days (Median) |
|---|
| Abiraterone Acetate | 457 |
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response at Week 12
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later. (NCT00474383)
Timeframe: Baseline, Week 12
| Intervention | percentage of participants (Number) |
|---|
| Abiraterone Acetate | 36.2 |
Duration of PSA Response
Duration of PSA response was the time between the date of first PSA response (greater than or equal to 50 percent decline from Baseline) and the date of PSA progression as defined by the PSAWG. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement. (NCT00474383)
Timeframe: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)
| Intervention | days (Median) |
|---|
| Abiraterone Acetate | 169 |
Shift From Baseline in Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score at Post-dose (Week 148)
The ECOG performance status score ranges from 0 to 5 where 0=fully active, perform all pre-disease activities without restriction; 1=restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=ambulatory, capable of self-care, unable to carry out any work activities, up and about more than (>) 50 percentage of waking hours; 3=capable of limited self-care, confined to bed or chair >50 percentage of waking hours; 4=completely disabled, not capable of any self-care, totally confined to bed or chair; and 5=dead. (NCT00474383)
Timeframe: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Day 1 of each cycle)
| Intervention | participants (Number) |
|---|
| Baseline, ECOG 0 | Baseline, ECOG 1 | Baseline, ECOG 2 | Best Post-Baseline. ECOG 0 | Best Post-Baseline. ECOG 1 | Best Post-Baseline. ECOG 2 |
|---|
| Abiraterone Acetate | 16 | 27 | 4 | 25 | 19 | 3 |
Time to PSA Progression
The time to PSA progression was the interval from the date of the first dose of abiraterone acetate to the date of PSA progression as defined by the PSAWG criteria. PSA progression was defined as a 50 percent increase over the nadir PSA value, increase in the PSA level by at least 5 nanogram per milliliter (ng/mL), and confirmed by second consecutive measurement. (NCT00474383)
Timeframe: Baseline until first documented disease progression or up to end of study (Week 148; assessed on Days 1, 8 of Cycle 1, thereafter Day 1 of each Cycle)
| Intervention | days (Median) |
|---|
| Abiraterone Acetate | 169 |
Overall Survival
Overall survival was defined as the interval from the date of the first dose of abiraterone acetate to the date of death. (NCT00474383)
Timeframe: Baseline until death, or end of study (Week 148)
| Intervention | days (Median) |
|---|
| Abiraterone Acetate | 380 |
Percentage of Participants With Confirmed Objective Tumor Response as Per Response Evaluation Criteria in Solid Tumors (RECIST)
The objective tumor response was defined as the percentage of participants achieving a complete (CR) or partial response (PR) on tumor response assessed as per RECIST. The CR was disappearance of all lesions. The PR was at least a 30 percent decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Baseline sum LD. (NCT00474383)
Timeframe: Baseline until first documented disease progression or end of study visit (Week 148; assessed on Day 1 of Cycle 4, 7, 10, and thereafter Day 1 of each cycle)
| Intervention | percentage of participants (Number) |
|---|
| Abiraterone Acetate | 26.1 |
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criteria, which was, greater than or equal to 50 percent decrease in PSA from Baseline and confirmed by subsequent measurement at least 4 weeks later. (NCT00474383)
Timeframe: Baseline up to Week 12
| Intervention | percentage of participants (Number) |
|---|
| Abiraterone Acetate | 44.7 |
Prostate-Specific Antigen Based Progression-free Survival (PSA-PFS)
The PSA-PFS is defined as time to first PSA failure (that is, two consecutive increases in PSA of 50 percent and greater than or equal to 5 nanogram per milliliter, as per Prostate-Specific Antigen Working Group [PSAWG] criterion) or death or the start of secondary anti-tumor therapy, whichever occurs first. If a PSA progression or death does not occur, subject will be censored at the last PSA evaluation. (NCT00485303)
Timeframe: Baseline and Day 1 of each cycle until first documented disease progression or up to 60 months
| Intervention | days (Median) |
|---|
| Abiraterone | 141 |
Time to PSA Progression
The time interval from first dose of abiraterone acetate to the date of PSA progression as defined by the Prostate-Specific Antigen Working Group (PSAWG) criteria. If a PSA progression does not occur, subject will be censored at the last PSA evaluation. (NCT00485303)
Timeframe: Day 8 of Cycle 1, thereafter Day 1 of each cycle up to end of study (60 months)
| Intervention | days (Median) |
|---|
| Abiraterone | 169 |
Time to Radiographic Progression
Time to radiographic progression is defined as the time from first dose until the first radiographic progression date that was confirmed. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
| Intervention | days (Median) |
|---|
| Abiraterone | 88 |
Percentage of Participants With Clinical Benefit
Clinical benefit was defined as an observation of at least 1 of the following: PSA response by PSAWG criteria; radiographic response by RECIST criteria; stable disease by RECIST criteria lasting 6 months; or improvement by at least 1 unit in ECOG performance status. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
| Intervention | percentage of participants (Number) |
|---|
| Disease Stabilization | Change in participant ECOG score |
|---|
| Abiraterone | 12 | 16 |
Percentage of Participants With Objective Radiographic Response
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
| Intervention | percentage of participants (Number) |
|---|
| Complete response (CR) | Partial Response (PR) |
|---|
| Abiraterone | 0 | 6.3 |
Radiographic Progression Free Survival (PFS)
The RAD-PFS is defined as the time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0, as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. (NCT00485303)
Timeframe: Baseline, Day 1 of Cycle 4, 7 and 10, and thereafter every third cycle until first documented disease progression or up to 60 months
| Intervention | days (Median) |
|---|
| Abiraterone | 126 |
Overall Survival (OS)
Overall survival is defined as the interval from the date of the first dose of abiraterone acetate to the date of death. (NCT00485303)
Timeframe: Every 3 months until death or up to 60 months
| Intervention | days (Median) |
|---|
| Abiraterone | 492 |
Percentage of Participants With Prostate Specific Antigen (PSA) Response
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response. (NCT00485303)
Timeframe: Day 1 of each cycle (of 28 days each) up to Cycle 12
| Intervention | percentage of participants (Number) |
|---|
| Abiraterone | 37.9 |
Number of Participants With Detectable Bone Marrow Dihydrotestosterone (DHT) Level (>9 Picograms/Mililiter)
(NCT00544440)
Timeframe: Baseline (predose Week 1 Day 1) and Week 8
| Intervention | Number of Participants (Number) |
|---|
| Baseline (predose Week 1 Day 1) (n=49) | Week 8 (n=44) |
|---|
| Abiraterone Acetate | 2 | 2 |
Number of Participants With Detectable Bone Marrow Testosterone Level (>1 Picograms/Mililiter)
(NCT00544440)
Timeframe: Baseline (predose Week 1 Day 1) and Week 8
| Intervention | Number of Participants (Number) |
|---|
| Baseline (predose Week 1 Day 1) (n=49) | Week 8 (n=44) |
|---|
| Abiraterone Acetate | 0 | 0 |
Number of Patients Achieving a Prostate-Specific Antigen Decline >=50%
A prostate-specific antigen (PSA) response was defined as a >=50% decline from baseline. (NCT00638690)
Timeframe: Up to 12 months
| Intervention | Participants (Number) |
|---|
| Abiraterone Acetate | 232 |
| Placebo | 22 |
Overall Survival
Overall survival is defined as the time interval from the date of randomization to the date of death from any cause. (NCT00638690)
Timeframe: Up to 60 months
| Intervention | Days (Median) |
|---|
| Abiraterone Acetate | 450.0 |
| Placebo | 332.0 |
Time to Prostate-Specific Antigen Progression According to Prostate Specific Antigen Working Group Criteria
The time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group (PSAWG) criteria, namely, a PSA level of at least 5 ng/ml that has risen on at least 2 successive occasions, at least 2 weeks apart. (NCT00638690)
Timeframe: Up to 12 months
| Intervention | Days (Median) |
|---|
| Abiraterone Acetate | 309.0 |
| Placebo | 200.0 |
Radiographic Progression-free Survival
Radiographic progression-free survival is based on imaging studies according to modified Response Evaluation Criteria in Solid Tumors (RECIST): baseline lymph node size must be >=2.0 cm to be considered a target lesion; progression on bone scans with >=2 new lesions not consistent with tumor flare, confirmed on a second scan >=6 weeks later that shows >=1 additional new lesion. (NCT00638690)
Timeframe: Up to 11 months
| Intervention | Days (Median) |
|---|
| Abiraterone Acetate | 171.0 |
| Placebo | 110.0 |
Number of Participants With Treatment Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state. (NCT00887198)
Timeframe: From first dose of study drug up to 30 days after the last dose of study drug
| Intervention | Participants (Number) |
|---|
| With Treatment-Emergent Adverse Events | With Treatment-Emergent Serious Adverse Events |
|---|
| Abiraterone Acetate + Prednisone (AAP) | 541 | 208 |
,| Placebo | 524 | 148 |
,| Placebo to Abiraterone Acetate | 93 | 39 |
Time to Prostate-specific Antigen (PSA) Progression
The time interval from the date of randomization to the date of PSA progression as defined in the protocol-specific prostate cancer Working Group 2 (PCWG2) criteria. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase from nadir and an absolute increase of 2 nanogram/milliliter ((ng/mL) or more, which is confirmed by a second value obtained in 3 or more weeks. Participants who had no PSA progression at the time of the analysis were censored at the last known date of no PSA progression. Participants with no on-study PSA assessment or no baseline PSA assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to date of PSA progerssion or cutoff date (Month 18)
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate + Prednisone (AAP) | 11.07 |
| Placebo | 5.55 |
Time to Opiate Use for Prostate Cancer Pain
The time interval from the date of randomization to the date of opiate use for cancer pain. Participants who have no opiate use at the time of analysis were censored at the last known date of no opiate use for cancer pain. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to first opiate use or end of study (Month 60)
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate + Prednisone (AAP) | 33.38 |
| Placebo | 23.39 |
Time to Initiation of Cytotoxic Chemotherapy
The time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. Participants who had no cytotoxic chemotherapy administration at the time of analysis were censored at the last known date when no cytotoxic chemotherapy was administered. Participants with no assessment were censored at the date of randomization. (NCT00887198)
Timeframe: From randomization (Day 1) up to initiation of cytotoxic chemotherapy or cutoff date (Month 18)
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate + Prednisone (AAP) | 25.17 |
| Placebo | 16.82 |
Radiographic Progression-free Survival (rPFS)
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate + Prednisone (AAP) | NA |
| Placebo | 8.28 |
Overall Survival
Overall survival is defined as the time from randomization to date of death from any cause. (NCT00887198)
Timeframe: From randomization (Day 1) up to end of study (Month 60)
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate + Prednisone (AAP) | 34.66 |
| Placebo | 30.29 |
Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry
The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care. (NCT01023061)
Timeframe: Week 12
| Intervention | pg/mg (Median) |
|---|
| Treatment (Antihormone Therapy and Radiation Therapy) | 0.050 |
Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method. (NCT01023061)
Timeframe: Up to 24 months after initiation of radiation therapy
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Antihormone Therapy and Radiation Therapy) | 6 |
Number of Participants With a Positive Surgical Margin at Radical Prostatectomy
The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate. (NCT01088529)
Timeframe: At the end of Cycle 3 (at radical prostatectomy)
| Intervention | participants (Number) |
|---|
| AA+LHRHa | 6 |
| LHRHa | 6 |
Number of Participants With Prostate-Specific Antigen Response
The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL. (NCT01088529)
Timeframe: Cycle 3 Day 1
| Intervention | participants (Number) |
|---|
| AA+LHRHa | 32 |
| LHRHa | 0 |
Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2. (NCT01088529)
Timeframe: At the end of Cycle 3 (at radical prostatectomy)
| Intervention | participants (Number) |
|---|
| AA+LHRHa | 24 |
| LHRHa | 8 |
Proportion of Patients With PSA Decline of > 50%
(NCT01199146)
Timeframe: 12 weeks from beginning of therapy
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate | 19 |
Time To Progression (TTP)
(NCT01199146)
Timeframe: beginning of treatment until disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria
| Intervention | weeks (Median) |
|---|
| Abiraterone Acetate | 16 |
Preliminary Evidence of Efficacy of Abiraterone Acetate
number of patients with ≥ 30% PSA decline after 12 weeks of abiraterone treatment (NCT01199146)
Timeframe: 12 weeks from beginning of abiraterone treatment
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate | 20 |
Number of Patients With PSA Partial Response
PSA reduction to < 4 ng/ml, but >0.2 ng/ml (NCT01309672)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate + Prednisone | 13 |
Number of Patients With Undetectable PSA
undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders. (NCT01309672)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate + Prednisone | 5 |
Overall Survival
(NCT01309672)
Timeframe: 3 years
| Intervention | months (Median) |
|---|
| Abiraterone Acetate + Prednisone | 25.8 |
Objective Progression-free Survival
Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease. (NCT01309672)
Timeframe: 3 years
| Intervention | months (Median) |
|---|
| Abiraterone Acetate + Prednisone | 17.5 |
Number of Patients With Toxicity of Abiraterone Acetate
Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT01309672)
Timeframe: Up to 3 years
| Intervention | Participants (Number) |
|---|
| Alanine aminotransferase increased | Anorexia | Aspartate aminotransferase increased | Hyperglycemia | Hypertension | Hypokalemia | INR increased | Leukocytosis | Lung infection | Nausea | Rectal hemorrhage | Thromboembolic event | Vomiting | Weight gain |
|---|
| Abiraterone Acetate + Prednisone | 2 | 1 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | 2 | 1 | 1 | 2 | 1 |
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. (NCT01314118)
Timeframe: End of core study visit (Approximately at Month 6)
| Intervention | Percentage of participants (Number) |
|---|
| Abiraterone Acetate and Prednisone | 86.9 |
Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment
Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement. (NCT01314118)
Timeframe: End of Cycle 3 (Approximately Month 3)
| Intervention | Percentage of Participants (Number) |
|---|
| Abiraterone Acetate and Prednisone | 85.2 |
Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks. (NCT01314118)
Timeframe: Maximum up to Month 30.5
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate and Prednisone | 28.7 |
Time to Radiographic Evidence of Disease Progression (TTRP)
Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes. (NCT01314118)
Timeframe: Maximum up to Month 30.5
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate and Prednisone | NA |
Overall Response Rate (ORR)
Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years
| Intervention | Percentage of participants (Number) |
|---|
| Exemestane | 6.3 |
| Abiraterone Acetate + Prednisone | 5.8 |
| Abiraterone Acetate + Exemestane + Prednisone | 12.1 |
Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment
Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)
| Intervention | Picomoles Per Liter (Pmol/L) (Mean) |
|---|
| Estradiol | Estrone |
|---|
| Abiraterone Acetate + Exemestane + Prednisone | -1.04 | -30.60 |
,| Abiraterone Acetate + Prednisone | -3.35 | -28.09 |
,| Exemestane | 1.53 | -34.20 |
Progression-Free Survival (PFS)
Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. (NCT01381874)
Timeframe: Approximately 2 years
| Intervention | Months (Median) |
|---|
| Exemestane | 3.68 |
| Abiraterone Acetate + Prednisone | 3.65 |
| Abiraterone Acetate + Exemestane + Prednisone | 4.47 |
Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. (NCT01381874)
Timeframe: Approximately 2 years
| Intervention | Percentage of participants (Number) |
|---|
| Exemestane | 12.7 |
| Abiraterone Acetate + Prednisone | 9.6 |
| Abiraterone Acetate + Exemestane + Prednisone | 22.7 |
Duration of Response
Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. (NCT01381874)
Timeframe: Approximately 2 years
| Intervention | months (Median) |
|---|
| Exemestane | 6.47 |
| Abiraterone Acetate + Prednisone | 4.86 |
| Abiraterone Acetate + Exemestane + Prednisone | 6.93 |
Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment
Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. (NCT01381874)
Timeframe: Baseline and End of treatment (approximately 2 years)
| Intervention | Nanomoles Per Liter (nmol/L) (Mean) |
|---|
| Progesterone | Testosterone |
|---|
| Abiraterone Acetate + Exemestane + Prednisone | 12.34 | -0.48 |
,| Abiraterone Acetate + Prednisone | 8.98 | -0.51 |
,| Exemestane | -4.80 | -0.09 |
Overall Survival (OS)
OS was calculated as the time from randomization to death from any cause. (NCT01381874)
Timeframe: Approximately 3 years
| Intervention | Months (Median) |
|---|
| Exemestane | NA |
| Abiraterone Acetate + Prednisone | 26.41 |
| Abiraterone Acetate + Exemestane + Prednisone | NA |
Prostate-Specific Antigen (PSA) Response
PSA response was defined as decline of 50% from baseline confirmed by a PSA at least 4 weeks later based on Prostate-specific Antigen Working Group-2 (PSAWG-2) (2008) criteria. (NCT01393730)
Timeframe: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone + Prednisone + Dutasteride | 34 |
Time to Progression (TTP)
TTP based on the Kaplan-Meier method is defined as the duration of time from study entry to documented first observation of progressive disease (PD). Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT01393730)
Timeframe: Disease evaluation occurred every 12 weeks while patients were receiving treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
| Intervention | Months (Median) |
|---|
| Abiraterone + Prednisone + Dutasteride | 11 |
Change in Serum Androgen Levels
Serum androgen levels measured based on established methods. The change from baseline to progression was calculated for each participant. (NCT01393730)
Timeframe: Pairs of patients' samples for androgen analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.
| Intervention | ng/dl (Median) |
|---|
| Abiraterone + Prednisone + Dutasteride | 1.2 |
Time to PSA Progression
Time to PSA progression based on the Kaplan-Meier method was defined as the time between registration and documented PSA progression. PSA progression based on Prostate-Specific Antigen Working Group-2 (PSAWG-2) (2008) criteria was an increase of >/=25% and >/= 2 ng/ml after 12 weeks for patients without a PSA decline from baseline and an increase of >/=25% and >/= 2 ng/ml above the nadir, confirmed by a 2nd value 3 weeks or later for patients with a PSA decline from baseline. PSA progression was reported not duration of response. (NCT01393730)
Timeframe: PSA was measured at baseline and day 1 of every cycle on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
| Intervention | months (Median) |
|---|
| Abiraterone + Prednisone + Dutasteride | 5 |
Presence of AR Amplification
Presence of AR amplification was measured by established methods. (NCT01393730)
Timeframe: Patients' samples were evaluated at baseline and every 12 weeks on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone + Prednisone + Dutasteride | 10 |
Change in Serum Levels of Testosterone
Serum testosterone levels were estimated based on established methods. The change from baseline to progression was calculated for each participant. (NCT01393730)
Timeframe: Samples for testosterone analyses were obtained at baseline and at time of progression. In this study cohort, participants were followed up to 48 months for this endpoint.
| Intervention | ng/dL (Median) |
|---|
| Abiraterone + Prednisone + Dutasteride | 0.25 |
Best Overall Response
Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT01393730)
Timeframe: Disease was evaluated radiologically at baseline and every 12 weeks cycles on treatment. In this study cohort, participants were followed up to 48 months for this endpoint.
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone + Prednisone + Dutasteride | 6 |
Cumulative CD54 Upregulation Ratio Between the Cohorts.
An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included. (NCT01487863)
Timeframe: Over the course of sipuleucel-T therapy (approximately 1 month)
| Intervention | Ratio ofCD54 molecules on BDS65:FP cells (Mean) |
|---|
| Concurrent Arm | 36.72 |
| Sequential Arm | 41.61 |
Change in Tissue Testosterone and Dihydrotestosterone
Tissue testosterone will be measured in biopsy tissues (NCT01503229)
Timeframe: From baseline to week 4
| Intervention | pg/mg (Median) |
|---|
| Treatment (Abiraterone Acetate and Prednisone) | 0.156 |
Phase 2: Objective Progression Free Survival (PFS)
"Objective PFS was defined as the time interval between the date of enrollment and the first occurrence of any of the events:~1) Radiological tumor progression (assessed using Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1) was defined as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. in case of progressive disease (PD) diagnosed only on non target bone lesions on bone scan, PD was to be considered only in case of appearance of at least 2 new lesions on bone scan confirmed 6 weeks later by another bone scan, and at least the appearance of 2 new additional lesions. 2) Death due to any cause.~Analysis was performed by Kaplan-Meier method." (NCT01511536)
Timeframe: From baseline until radiological tumor or disease progression or death due to any cause, assessed up to Month 5
| Intervention | months (Median) |
|---|
| Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | NA |
Phase 1: Maximally Tolerated Dose (MTD) of Cabazitaxel in Combination With Abiraterone Acetate
MTD was defined as highest dose level of cabazitaxel in combination with abiraterone acetate at which no more than 1 participant experienced dose limiting toxicities (DLT). DLT was defined as any of the following events related to study treatment: 1) Grade 3 or 4 non-hematological related adverse event with exception of Grade 3 fever without documented infection; Grade 3 nausea, vomiting, or diarrhea in the absence of effective maximal therapy; and Grade 3 hypersensitivity reaction in the absence of required premedication. 2) Hematological toxicity: Febrile neutropenia (fever of unknown origin ≥38.5°C with neutropenia Grade 3 or 4); Neutropenia Grade 4 lasting >7 days; Thrombocytopenia Grade 4 or Grade 3 complicated by hemorrhage. 3) Re-treatment delay of more than 2 weeks due to delayed recovery from a toxicity related to study treatment to baseline or ≤ Grade 1 (except for alopecia). Grades were based on National Cancer Institute CommonTerminology Criteria for Adverse Events v4.03. (NCT01511536)
Timeframe: Up to Cycle 2 of Phase 1 (up to 42 days)
| Intervention | mg/m^2 (Number) |
|---|
| Phase 1: Overall Population | 25 |
Phase 2: PSA Progression Free Survival
"Prostate-specific antigen progression-free survival was defined as the time interval between the date of treatment start and the date of either first documented PSA progression or death due to any cause, whichever was earlier. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA.~Analysis was performed by Kaplan Meire method." (NCT01511536)
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)
| Intervention | months (Median) |
|---|
| Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 6.93 |
Phase 2: Pharmacokinetic of Cabazitaxel : Volume of Distribution at Steady State (Vss)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
| Intervention | L/m^2 (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 2711 |
Phase 2: Percentage of Participants With Objective Response
Objective response was defined as having complete response (CR) or Partial Response (PR) assessed by RECIST 1.1. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level and all lymph nodes size was <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters). (NCT01511536)
Timeframe: Baseline, every 12 weeks there after until disease progression (maximum duration: 603 days)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 21.4 |
Phase 2: Overall Survival
Overall survival was defined as the time interval from the date of treatment start to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earlier of the last date the participant was known to be alive and the study cut-off date. Analysis was performed by Kaplan-Meier method. (NCT01511536)
Timeframe: From baseline up to death or study cut-off (maximum duration: 603 days)
| Intervention | months (Median) |
|---|
| Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | NA |
Phase 2: Percentage of Participants With Prostate Specific Antigen (PSA) Response
Prostate specific antigen (PSA) response was defined as ≥50% decrease from baseline in serum PSA levels, confirmed at least 3 weeks later. Increases of any magnitude during the first 12 weeks were ignored in determining PSA response. PSA was to be measured at baseline, every 3 weeks, throughout study period, until progression. PSA progression was defined as: -An increase of 25% above the nadir (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have achieved a ≥50% decline of PSA. -An increase in PSA by 25 % above the baseline level (at least 2 ng/mL), confirmed by a second PSA value at least 3 weeks apart, in participants who have not achieved a ≥50% decline of PSA. (NCT01511536)
Timeframe: Baseline, every 3 weeks up to PSA progression (maximum duration: 603 days)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 46.2 |
Phase 2: Pharmacokinetic of Abiraterone : Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours (AUC 0-24)
Area under the plasma concentration-time curve calculated using the trapezoidal method from time zero to 24 hours corresponding to abiraterone acetate dosing interval. (NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
| Intervention | ng*h/mL (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 928 |
Phase 2: Pharmacokinetic of Abiraterone : Concentration Observed Just Before Treatment Administration During Repeated Dosing at Steady State (Ctrough ss)
(NCT01511536)
Timeframe: Pre abiraterone dose on Day 1 of Cycle 1
| Intervention | ng/mL (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 9.99 |
Phase 2: Pharmacokinetic of Abiraterone : First Time to Reach Cmax (Tmax)
(NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
| Intervention | hour (Median) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 2.00 |
Phase 2: Pharmacokinetic of Abiraterone : Maximum Plasma Concentration Observed (Cmax)
(NCT01511536)
Timeframe: 0 hour (before abiraterone administration); 1, 2, 4, 6, 8, 12, 24 hours post abiraterone administration on Day 1-Cycle 1
| Intervention | ng/mL (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 216 |
Phase 2: Pharmacokinetic of Cabazitaxel : Area Under the Plasma Concentration Versus Time Curve (AUC)
Area under the concentration-time curve calculated using the following equation: AUC = Plasma clearance (CL)/dose (NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
| Intervention | ng*h/mL (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 817 |
Phase 2: Pharmacokinetic of Cabazitaxel : Maximum Plasma Concentration Observed (Cmax)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
| Intervention | ng/mL (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg | 330 |
Phase 2: Pharmacokinetic of Cabazitaxel : Terminal Half-life (t 1/2z)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
| Intervention | hour (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 91.6 |
Phase 2: Pharmacokinetic of Cabazitaxel : Total Plasma Clearance (CL)
(NCT01511536)
Timeframe: 5 minutes before cabazitaxel infusion; at end of cabazitaxel infusion; 0.25 hours post-cabazitaxel infusion; any time between 1 to 4 hours, between 6 to 24 hours, between 48 to 96 hours post cabazitaxel infusion on Day 1-Cycle 1
| Intervention | L/h/m^2 (Mean) |
|---|
| Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg | 31.4 |
Number of Participants With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. (NCT01517802)
Timeframe: Up to 9 years
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate + Prednisone/Prednisolone | 16 |
Progression-free Survival (PFS)
Time to PSA progression (25% increase from baseline), radiographic progression, or death. (NCT01543776)
Timeframe: Assessed up to 3 years
| Intervention | Months (Median) |
|---|
| Arm I (Fasting) | 8.6 |
| Arm II (Fed) | 8.6 |
Peak Plasma Concentration of Abiraterone
Analyzed on a log scale due to skewness of distribution (NCT01543776)
Timeframe: Up to 4 months
| Intervention | log(ng/mL) (Mean) |
|---|
| Arm I (Fasting) | 5.39 |
| Arm II (Fed) | 4.65 |
Adrenal Androgen Production (DHEA-S)
Extragonadal serum adrogen (NCT01543776)
Timeframe: Cycle 4 (4 months)
| Intervention | microgram per deciliter (Mean) |
|---|
| Arm I (Fasting) | 13.30 |
| Arm II (Fed) | 10.22 |
Change in PSA Level
Data were analyzed on a log scale: log(week 12) - log(baseline) = log ratio. Smaller (more negative) values indicate a better outcome. (NCT01543776)
Timeframe: From baseline to 12 weeks
| Intervention | log ratio (Mean) |
|---|
| Arm I (Fasting) | -1.19 |
| Arm II (Fed) | -1.59 |
Number of Participants With Adverse Events (AEs)
Patients with grade 3 or higher AE (CTCAE Version 4.03) (NCT01543776)
Timeframe: Assessed up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Fasting) | 6 |
| Arm II (Fed) | 11 |
Rates of PSA Decline
Change in PSA from baseline to 12 weeks (NCT01576172)
Timeframe: 12 weeks
| Intervention | ng/ml (Mean) |
|---|
| Arm I (Abiraterone Acetate and Prednisone) | -41.1 |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | -52.9 |
Progression-free Survival (PFS)
Time from randomization to disease progression or death. (NCT01576172)
Timeframe: Up to 42 months
| Intervention | months (Median) |
|---|
| Arm I (Abiraterone Acetate and Prednisone) | 10.1 |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 11.0 |
Objective Response Rates in Patients With Measurable Disease.
Overall response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01576172)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Abiraterone Acetate and Prednisone) | 18 |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 24 |
Confirmed Prostate-specific Antigen (PSA) Response Rate
50% or greater decline in PSA from baseline. (NCT01576172)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Abiraterone Acetate and Prednisone) | 46 |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 55 |
Grade 4 or 5 Adverse Events
Grade 4 or greater toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 at least possibly related to treatment. (NCT01576172)
Timeframe: 30 days after completion of study treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Abiraterone Acetate and Prednisone) | 1 |
| Arm II (Abiraterone Acetate, Prednisone, and Veliparib) | 3 |
Comparison of Circulating Androstenedione Levels Between Primary-Resistant Patients and Responders
The distribution of the baseline androstenedione levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
| Intervention | ng/dL (Mean) |
|---|
| Androstenedione in Primary Resistant (STD) | NA |
| Androstenedione in Responders (STD) | NA |
Time to PSA Progression for Dose Escalation Cohort
Time to PSA progression as defined by RECIST criteria or by the Prostate Cancer Working Group 2 (PCWG) criteria for patients whom were treated with increased dose Abiraterone Acetate. (NCT01637402)
Timeframe: up to 24 months
| Intervention | months (Median) |
|---|
| Dose Escalation | 12 |
Comparison of Circulating DHEA Levels Between Primary-Resistant and Responders
The distribution of the baseline DHEA levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
| Intervention | ng/dL (Mean) |
|---|
| Initial draw | Progression / Week 12 |
|---|
| DHEA in Primary Resistant (STD) | 56.2 | 28.5 |
,| DHEA in Responders (STD) | 79.4 | 13.5 |
Serum Concentration Levels of Abiraterone Acetate Over Time
Pharmacokinetic assessment at the initiation of standard dose therapy, at the time of initial disease progression, at the time of a response to increased dose of abiraterone acetate and at the time of disease progression on increased-dose therapy. (NCT01637402)
Timeframe: Up to 24 months
| Intervention | nanograms per millilitre (ng/mL) (Median) |
|---|
| Concentration at First Draw on Standard Dose Therapy (4 Weeks) | 5.5 |
| Concentration at Time of Disease Progression on Standard Dose | 14.2 |
| Concentration at Time of Disease Progression on Increased Dose | 31.5 |
Number of Patients With PSA Response From Dose Escalation
A PSA response for the dose escalation group is defined as a participant with a documented PSA decline after 12 weeks of therapy with standard-dose, then had disease progression, and then achieved a ≥30% PSA decline after 12 weeks from the start of dose escalation therapy. (NCT01637402)
Timeframe: Up to 12 weeks from start of dose escalation
| Intervention | Participants (Count of Participants) |
|---|
| Dose Escalation | 0 |
Correlation of Circulating Dehydroepiandrosterone (DHEA) Levels From Baseline to Week 12
"Pearson's correlation coefficients (r) will be calculated to summarize the relationship between DHEA values at baseline and at 12 weeks. DHEA labs will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. Coefficients are on a continuous scale ranging from -1 to +1 with a value of -1 indicating a perfect negative linear association of DHEA levels between the 2 time points, a value of 0 indicating no association between DHEA levels between the two time points, and a value of +1 indicating a positive linear association of DHEA levels between the two time points." (NCT01637402)
Timeframe: Baseline and Week 12
| Intervention | correlation coefficient (r) (Number) |
|---|
| Standard Dose | 0 |
Comparison of Circulating Testosterone Levels Between Primary-Resistant Patients and Responders
The distribution of the baseline testosterone levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
| Intervention | Nanograms per decilitre (ng/dL) (Mean) |
|---|
| Testosterone in Primary Resistant (STD) | NA |
| Testosterone in Responders (STD) | NA |
Comparison of Circulating DHEA-S Levels Between Primary-Resistant Patients and Responders
The distribution of the baseline DHEA-S levels and the change in hormone level at 12 weeks will be compared between patients experiencing a PSA decline >30% (responders) and patients without such a PSA decline (primary-resistant) using a two group t statistic. Measurements will be obtained at an earlier time point if the patient comes off study for disease progression before week 12. (NCT01637402)
Timeframe: Baseline and Week 12
| Intervention | microgram per deciliter (µg/dL) (Mean) |
|---|
| DHEA-S in Primary Resistant (STD) | NA |
| DHEA-S in Responders (STD) | NA |
Change From Baseline in Androstenedione Concentration in Blood
Androstenedione concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | -0.24 |
Bone Scan Response at EoT
PD: ≥1 of 3 criteria: PSA progression: ≥2 rising PSA levels, interval of ≥1 week between each determination. Soft tissue disease progression: RECIST 1.1. Bone disease progression: PCWG2 criteria (≥2 or new lesions on bone scan compared with prior scan). Target lesion CR: disappearance of all target lesions, PR as ≥30% decrease in sum of longest diameter (LD) of target lesions, referencing baseline sum LD, SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referencing smallest sum LD since treatment start, PD ≥20% increase in sum of LD of target lesions, referencing smallest sum LD recorded since treatment start or appearance of ≥1 new lesions. Non-target lesions CR: disappearance of all non-target lesions and normalization of tumor marker level, SD: persistence of ≥1 non-target lesions and/or maintenance of tumor marker level above normal limits, PD: appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. (NCT01650194)
Timeframe: EoT; the median duration of treatment was 10.1 months.
| Intervention | Participants (Count of Participants) |
|---|
| Complete Response (CR) | Progressive Disease (PD) | Non-CR/Non-PD | Not Evaluable |
|---|
| Enzalutamide + Abiraterone + Prednisone | 1 | 15 | 35 | 1 |
Change From Baseline in Cortisol in Bone Marrow Aspirate
Cortisol in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | -46.86 |
Change From Baseline in Pregnenolone Concentration in Blood
Pregnenolone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | pg/ml (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 1507.42 |
Change From Baseline in Pregnenolone in Bone Marrow Aspirate
Pregnenolone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | pg/ml (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 1381.44 |
Change From Baseline in Androstenedione in Bone Marrow Aspirate
Androstenedione in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | -0.32 |
Change From Baseline in Progesterone Concentration in Blood
Progesterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 1.43 |
Change From Baseline in Progesterone in Bone Marrow Aspirate
Progesterone in bone marrow aspirate was measured by laboratory results derived from bone marrow samples. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 1.16 |
Change From Baseline to End-of-Treatment (EoT) in Prostate-Specific Antigen (PSA) Levels
Prostate-specific antigen progression by Prostate Cancer Clinical Trials Working Group 2 (PCWG2) was defined as a PSA increase ≥25% and ≥2 ng/ml above the post-baseline nadir, and which was confirmed by the first subsequent value of 3 or more weeks later. (NCT01650194)
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.
| Intervention | ug/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 36.35 |
Change From Baseline in Testosterone Concentration in Blood
Testosterone concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | -0.06 |
Change From Baseline in Cortisol Concentration in Blood
Cortisol concentration in blood was measured by laboratory results derived from plasma samples. Plasma samples were derived from collected blood samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | -48.81 |
Change From Baseline in Testosterone Concentration in Bone Marrow Aspirate
Testosterone concentration in bone marrow aspirate was measured by laboratory results derived from bone marrow samples processed through liquid chromatography mass spectrometry. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | pmol/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | -19.48 |
Change From Baseline in Urine N-Telopeptide
Bone metabolism marker urine N-telopeptide levels were derived from urine samples collected. (NCT01650194)
Timeframe: Baseline and Week 9
| Intervention | nmolBCE/mmolcreat (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 29.35 |
Change From Baseline to EoT in Bone Specific Alkaline Phosphatase
Bone metabolism marker bone specific alkaline phosphatase levels were derived from blood samples collected. (NCT01650194)
Timeframe: Baseline and EoT; the median duration of treatment was 10.1 months.
| Intervention | ug/L (Geometric Mean) |
|---|
| Enzalutamide + Abiraterone + Prednisone | -5.18 |
Percentage of Participants With Objective Response for Soft Tissue Lesions According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST)
Objective response was based on RECIST version 1.1 for soft tissue lesion on Magnetic resonance imaging (MRI) / Computerized tomography (CT) and the PCWG2 guidelines for bone lesions on bone scans and was defined as partial response (PR) or complete response (CR) based on the investigators' assessments of target, non-target and new lesions while on study treatment. The 95% for objective response rate was based on exact binomial 95% confidence interval (Clopper-Pearson). (NCT01650194)
Timeframe: Up to 1849 days
| Intervention | percentage of participants (Median) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 68.8 |
Progression Free Survival (PFS)
PFS was measured as the time from the date of first dose of any drug of the study combination treatment until the first evidence of documented progression (a composite endpoint consisting of radiographic progression or PSA progression by PCWG2 or clinical deterioration) or death in the absence of progression (whichever came first) or the date last known to be progression free. The Kaplan-Meier (KM) 95% CI was based on Brookmeyer and Crowley robust non-parametric method. (NCT01650194)
Timeframe: Up to 1849 days
| Intervention | days (Median) |
|---|
| Enzalutamide + Abiraterone + Prednisone | 251 |
Number of Participants With Adverse Events (AEs)
A treatment-emergent adverse event (TEAE) was defined as an adverse event occurring or worsening between the start of study treatment date and the latest date of 30 days after the last dose date or the 30-day follow-up visit date, and not later than the data cut-off date or the date of death. AEs, including abnormal clinical laboratory values, were graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) guidelines (V4.03). (NCT01650194)
Timeframe: From the first dose of study drug administration up 30 days following the last dose of study drug date, with a median duration of treatment of 10.1 months.
| Intervention | Participants (Count of Participants) |
|---|
| Any TEAE | Enzalutamide-related TEAEs | Abiraterone-related TEAEs | Prednisone-related TEAEs | Deaths | Serious TEAEs | Enzalutamide-related serious TEAEs | Abiraterone-related serious TEAEs | Prednisone-related serious TEAEs | TEAEs leading to discontinuation of enzalutamide | Enza-related TEAEs leading to disc. of enza | Abiraterone-related TEAEs leading to disc. of enza | Prednisone-related TEAEs leading to disc. of enza | TEAEs leading to discontinuation of abiraterone | Abiraterone-related TEAEs leading to disc. of abi |
|---|
| Enzalutamide + Abiraterone + Prednisone | 60 | 56 | 58 | 16 | 0 | 10 | 0 | 2 | 0 | 3 | 0 | 0 | 0 | 1 | 1 |
Circulating Tumor Cell (CTC) Counts
Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study (NCT01681433)
Timeframe: Every 4 weeks
| Intervention | participants (Number) |
|---|
| Best CTC Change from Baseline >=5 to <5 | Best CTC Change from Baseline <5 to <5 | Best CTC Change from Baseline >=5 to >=5 | Best CTC Change from Baseline<5 to >=5 |
|---|
| Control Arm: Arm B | 4 | 15 | 10 | 1 |
,| Experimental: Arm A | 8 | 16 | 7 | 1 |
Objective Response
Compare arms to determine the objective response of study patients, per RECIST 1.1 (NCT01681433)
Timeframe: 60 days
| Intervention | participants (Number) |
|---|
| Partial Response | Stable Disease | Progressive Disease |
|---|
| Control Arm: Arm B | 0 | 5 | 25 |
,| Experimental: Arm A | 1 | 6 | 26 |
PSA Response
Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization. (NCT01681433)
Timeframe: 60 days
| Intervention | participants (Number) |
|---|
| PSA DECLINE >= 30% | PSA DELCINE >=50 % | ANY DECLINE |
|---|
| Control Arm: Arm B | 2 | 1 | 11 |
,| Experimental: Arm A | 2 | 2 | 13 |
Time to Disease Progression
Compare arms to determine the time to disease progression of study patients (NCT01681433)
Timeframe: 60 days
| Intervention | months (Median) |
|---|
| Experimental: Arm A | 1.9055 |
| Control Arm: Arm B | 1.0842 |
Progression-Free Survival
To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B. (NCT01681433)
Timeframe: 60 days
| Intervention | participants (Number) |
|---|
| Experimental: Arm A | 12 |
| Control Arm: Arm B | 6 |
Time to PSA Progression
Time to PSA progression was measured as the time interval from the date of the first dose to the date of PSA progression as defined in the protocol-specific PSAWG criteria. For participants who have achieved a greater than or equal to (>=) 50% decrease from the baseline PSA, assessment of time to disease progression is when the PSA has increased 50% above the nadir and at a minimum of 5 nanogram/mililiter (ng/mL). For participants without a PSA decrease of this magnitude or without a decrease, the time for progression is calculated at the time a 25% increase from baseline PSA has been achieved. (NCT01685983)
Timeframe: Up to 28 Months
| Intervention | Days (Median) |
|---|
| Abiraterone Acetate and Prednisolone | 141 |
Percentage of Participants With Prostate-specific Antigen (PSA) Response
The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response. (NCT01685983)
Timeframe: Baseline, Month 4
| Intervention | Percentage of participants (Number) |
|---|
| Abiraterone Acetate and Prednisolone | 42.7 |
Percentage of Participants With Objective Radiographic Response
Percentage of participants with radiographic objective response is defined as the percentage of participants with complete response (CR) or partial response (PR) as best overall response based on reconciled radiographic disease assessment according to RECIST Version 1.0. The CR is disappearance of all lesions. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. (NCT01685983)
Timeframe: Up to 3 Years
| Intervention | Percentage of participants (Number) |
|---|
| Abiraterone Acetate and Prednisolone | 6.1 |
Overall Survival
Overall survival is defined as the time interval from the date of the first dose to the date of death due to any reason. (NCT01685983)
Timeframe: Up to 3 Years
| Intervention | Days (Median) |
|---|
| Abiraterone Acetate and Prednisolone | 538 |
Serum Testosterone
Median serum testosterone concentration was reported at baseline and End-of-Treatment visit. (NCT01685983)
Timeframe: Baseline and End-of-Treatment Visit (up to approximately 3 years)
| Intervention | nanomole per liter (Median) |
|---|
| Baseline | End-of-Treatment Visit |
|---|
| Abiraterone Acetate and Prednisolone | 1.210 | 1.210 |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT01685983)
Timeframe: Up to 3 Years
| Intervention | Participants (Number) |
|---|
| AEs | SAEs |
|---|
| Abiraterone Acetate and Prednisolone | 81 | 40 |
Dehydroepiandrosterone Sulfate (DHEA-S)
Median DHEA-S concentration was reported at baseline and End-of-Treatment visit. (NCT01685983)
Timeframe: Baseline and End-of-Treatment Visit (up to approximately 3 years)
| Intervention | micromole per liter (Median) |
|---|
| Baseline | End-of-Treatment Visit |
|---|
| Abiraterone Acetate and Prednisolone | 0.725 | 0.080 |
DB Phase: Overall Survival
Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. (NCT01695135)
Timeframe: From randomization to the date of death due to any cause (up to approximately 3.8 years)
| Intervention | Days (Median) |
|---|
| Placebo + Prednisone (Double-blind) | 561.00 |
| Abiraterone Acetate + Prednisone (Double-blind) | 579.00 |
DB Phase: Percentage of Participants Who Achieved PSA Response
Percentage of participants who achieved PSA response (defined as >= 50% PSA decline from baseline) according to PSAWG criteria were reported. PSAWG criteria- Decline from baseline and reach response criteria: >= 50% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later. (NCT01695135)
Timeframe: Approximately up to 3.8 years
| Intervention | Percentage of Participants (Number) |
|---|
| Placebo + Prednisone (Double-blind) | 18.3 |
| Abiraterone Acetate + Prednisone (Double-blind) | 54.5 |
DB Phase: Percentage of Participants Experiencing Pain Palliation
Percentage of participants experiencing pain palliation were reported. A participant is responder if experienced >=30% reduction in Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity score over 24 hours observed at 2 consecutive evaluations 4 weeks apart without any increase in analgesic usage score (best response). Analgesic usage was scored on a scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. BPI-SF is 11-item self-reported questionnaire designed to assess severity and impact of pain on daily functions. It includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. (NCT01695135)
Timeframe: Approximately up to 3.8 years
| Intervention | Percentage of Participants (Number) |
|---|
| Placebo + Prednisone (Double-blind) | 31.8 |
| Abiraterone Acetate + Prednisone (Double-blind) | 54.5 |
DB Phase: Time to Pain Progression
Time to Pain progression calculated as number of days from date of randomization to date of pain progression. Pain progression- worsening of pain due to metastatic bone disease defined as increase of >=30% in worst pain over past 24 hours on BPI-SF numeric rating scale at 2 consecutive evaluations 4 weeks apart without decrease in analgesic usage score (in 2 corresponding consecutive evaluation in analgesic usage score, if there is missing visit, use existing visit only) or increase in analgesic usage score >=30% at 2 consecutive evaluations 4 weeks apart. BPI-SF is 11-item questionnaire which includes 4 questions that assess pain intensity and 7 questions that assess impact of pain on daily functions. Total score (average of individual questions) ranges from 0=No pain to 10=Pain as bad as you can imagine; Higher scores= greater pain. Analgesic usage was scored on scale of 0 to 3 where 0=no analgesic, 1=non-opioid analgesics, 2=opioids for moderate pain and 3=opioids for severe pain. (NCT01695135)
Timeframe: Approximately up to 3.8 years
| Intervention | Days (Median) |
|---|
| Placebo + Prednisone (Double-blind) | 169.00 |
| Abiraterone Acetate + Prednisone (Double-blind) | 505.00 |
DB Phase: Time to Prostate-Specific Antigen Progression (PSA)
Time to PSA progression was defined as time interval from the date of randomization to the date of the prostate-specific antigen (PSA) progression as defined in the Prostate Specific Antigen Working Group (PSAWG) criteria. PSAWG criteria- Decline from baseline and reach response criteria: greater than or equal to (>=) 50 percent (%) increase over the nadir and the increase in the absolute-value by at least 5 nanogram per milliliter (ng/mL) (or back to the baseline), which is confirmed by a second value 4 or more weeks later; Decline from baseline but not reach response criteria: >=25% increase over the nadir and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later; and No decline from baseline: >=25% increase over the baseline and the increase in the absolute-value by at least 5 ng/mL, which is confirmed by a second value 4 or more weeks later. (NCT01695135)
Timeframe: Up to 1.8 years
| Intervention | Days (Median) |
|---|
| Placebo + Prednisone (Double-blind) | 84.00 |
| Abiraterone Acetate + Prednisone (Double-blind) | 169.00 |
DB Phase: Change From Baseline in Brief Fatigue Inventory (BFI) Score at End of Treatment
"The Brief Fatigue Inventory (BFI) is a brief participant-reported questionnaire that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. BFI has nine items. Three items ask patients to rate the severity of their fatigue at its worst, usual, and now during normal waking hours, with 0 being no fatigue and 10 being fatigue as bad as you can imagine. Six items assess the amount that fatigue has interfered with different aspects of the patient's life during the past 24 hours. The interference items include general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, and enjoyment of life. The interference items are measured on a 0-10 scale, with 0 being does not interfere and 10 being completely interferes. BFI Total Score is the average of the nine items, ranging from 0 (no fatigue) to 10 (high fatigue)." (NCT01695135)
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
| Intervention | Units on a scale (Mean) |
|---|
| Fatigue Now | Usual Fatigue | Worst Fatigue | General Activity | Mood | Walking Ability | Normal Work | Relations with Other People | Enjoyment of Life |
|---|
| Abiraterone Acetate + Prednisone (Double-blind) | 1.7 | 1.5 | 1.6 | 1.7 | 1.8 | 1.8 | 2.0 | 1.6 | 1.9 |
,| Placebo + Prednisone (Double-blind) | 2.4 | 2.4 | 2.6 | 2.3 | 2.7 | 2.4 | 2.2 | 2.0 | 2.5 |
DB Phase: Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire: Total Scores at the End of Treatment
FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the Prostate Cancer Subscale (PCS) (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item Quality of Life (QOL) measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), and Emotional (0-24) Well-being. The total range was between 1-108, higher scores better. Functional Assessment of Cancer Therapy-Treatment Outcome Index (FACT-TOI) is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better). PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). (NCT01695135)
Timeframe: Baseline, at End of Treatment (15 and 30 days after the last dose [up to 3.8 years])
| Intervention | Units on a scale (Mean) |
|---|
| Total Score | Physical Well-being | Functional Well-being | Emotional Well-being | Social Well-being | FACT-G Total Score | Prostate Cancer Subscale (PCS) | Treatment Outcome Index (FACT-TOI) |
|---|
| Abiraterone Acetate + Prednisone (Double-blind) | -16.1 | -4.9 | -2.7 | -2.4 | -1.2 | -11.2 | -4.9 | -12.5 |
,| Placebo + Prednisone (Double-blind) | -19.9 | -6.7 | -5.1 | -2.1 | -0.8 | -14.6 | -5.3 | -17.1 |
DB Phase: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01695135)
Timeframe: Approximately up to 3.8 years
| Intervention | Percentage of Participants (Number) |
|---|
| Placebo + Prednisone (Double-blind) | 4.2 |
| Abiraterone Acetate + Prednisone (Double-blind) | 17.5 |
Time to Initiation of Chemotherapy
Time to initiation of chemotherapy was defined as the time (in months) interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer. (NCT01715285)
Timeframe: Up to 66 months
| Intervention | months (Median) |
|---|
| Abiraterone Acetate+Prednisone+ADT | NA |
| Placebo + ADT | 57.59 |
Overall Survival (OS)
Overall survival was defined as the time from randomization to date of death from any cause. (NCT01715285)
Timeframe: Up to 66 months
| Intervention | months (Median) |
|---|
| Abiraterone Acetate+Prednisone+ADT | 53.32 |
| Placebo + ADT | 36.53 |
Radiographic Progression-Free Survival (PFS)
Radiographic PFS was defined as the time (in months) interval from randomization to the first date of radiographic progression or death. Radiographic progression included progression by bone scan (according to modified Prostate Cancer Working Group 2 [PCWG2] criteria), defined as at least 2 new lesions on bone scan and progression of soft tissue lesions by computed tomography (CT) or magnetic resonance imaging (MRI) (according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). As per the RECIST 1.1 guideline, progression requires a 20 percent (%) increase in the sum of diameters of all target lesions and a minimum absolute increase of 5 millimeter (mm) in the sum as compared to nadir sum of diameter. (NCT01715285)
Timeframe: Up to 44 months
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate+Prednisone+ADT | 33.02 |
| Placebo + ADT | 14.78 |
Time to Pain Progression
"Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing no pain and 10 representing pain as bad as you can imagine." (NCT01715285)
Timeframe: Up to 66 months
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate+Prednisone+ADT | 47.41 |
| Placebo + ADT | 16.62 |
Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression was defined as the time (in months) interval from the date of randomization to the date of PSA progression, according to PCWG2 criteria. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. (NCT01715285)
Timeframe: Up to 66 months
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate+Prednisone+ADT | 33.31 |
| Placebo + ADT | 7.43 |
Time to Subsequent Therapy for Prostate Cancer
Time to subsequent therapy was defined as the time (in months) interval from the date of randomization to the date of initiation of subsequent therapy for prostate cancer. (NCT01715285)
Timeframe: Up to 66 months
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate+Prednisone+ADT | 54.87 |
| Placebo + ADT | 21.22 |
Percentage of Patients With Undetectable PSA (Prostate-Specific Antigen) at 1 Year
The percentage of patients with undetectable PSA after 1 year will be calculated. Undetectable PSA is defined as a measurement of <0.1 ng/mL. (NCT01717053)
Timeframe: 1 year
| Intervention | percentage of participants (Number) |
|---|
| Abiraterone+Radiotherapy+ADT | 54.54 |
PSA Nadir Value
The lowest PSA value from the start of study therapy. (NCT01717053)
Timeframe: 1 year, 2 years
| Intervention | ng/mL (Median) |
|---|
| Year 1 | Year 2 |
|---|
| Abiraterone+Radiotherapy+ADT | 0.03 | 0.03 |
PSA < 1.5ng/ml in Setting of Non-castrate Testosterone
Percentage of men with 1, 2, 3, 4 and 5 year PSA < 1.5ng/ml in setting of non-castrate testosterone. (NCT01717053)
Timeframe: 1 year, 2 years, 3 years, 4 years, 5 years
| Intervention | percentage of patients (Number) |
|---|
| 1 year | 2 years | 3 years | 4 years | 5 years |
|---|
| Abiraterone+Radiotherapy+ADT | 100 | 100 | 90.91 | 90.91 | 90.91 |
Percentage of Participants With Biochemical Progression-free Survival (BPFS)
Disease progression defined as Phoenix RTOG definition of nadir PSA + 2ng/ml or initiation of salvage therapy not imaging. The two outcomes use different measures (biochemical as measured by PSA increase vs radiographic as measured by imaging), yielding different results in this case. (NCT01717053)
Timeframe: 36 and 48 months
| Intervention | percentage of participants (Number) |
|---|
| 36 months | 48 months |
|---|
| Abiraterone Acetate | 96.96 | 96.96 |
Time to PSA Nadir
The median time in months to the lowest PSA value from the start of study therapy. (NCT01717053)
Timeframe: 1 year
| Intervention | months (Median) |
|---|
| Abiraterone+Radiotherapy+ADT | 8.9 |
Testosterone Recovery
Time to testosterone recovery (NCT01717053)
Timeframe: up to 5 years
| Intervention | months (Median) |
|---|
| Abiraterone Acetate | 9.2 |
Safety and Tolerability
The number of patients experiencing an adverse event of at least grade 3 that is possibly, probably, or definitely related to study therapy per CTCAE version 4.0. (NCT01717053)
Timeframe: 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone+Radiotherapy+ADT | 12 |
Number of Reported Dose Limiting Toxicities When Combining BEZ235 With Abiraterone Acetate (Phase I).
(NCT01717898)
Timeframe: Beginning of study up to 15 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase I: BEZ235 200 mg | 3 |
| Phase I: BEZ235 300 mg | 0 |
| Phase I: BEZ235 400 mg | 0 |
| Phase II | 0 |
Anti-tumor Responses as Defined by a Decline in PSA of > 50%
Anti-tumor responses as defined by a decline in PSA of > 50% following 12 weeks of therapy to the combination of Abiraterone Acetate plus BEZ-235 occur in a cohort of patients who have received prior therapy with Abiraterone Acetate therapy (NCT01717898)
Timeframe: From day 1 of therapy initiation up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Phase I: BEZ235 200 mg | 0 |
| Phase I: BEZ235 300 mg | 0 |
| Phase I: BEZ235 400 mg | 0 |
| Phase II | 0 |
Maximum Tolerated Dose for BEZ235 + Abiraterone Acetate (Phase I).
Maximum Tolerated Dose (MTD) for BEZ235 + Abiraterone Acetate (to be determined during Phase I). The MTD of BEZ235 will be the dose when given in combination results in less than 33% dose limiting toxicities (DLT). (NCT01717898)
Timeframe: Beginning of study up to 15 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase I: BEZ235 200 mg | 0 |
| Phase I: BEZ235 300 mg | 0 |
| Phase I: BEZ235 400 mg | 0 |
| Phase II | 0 |
Number of Participants With ≥ 30% Change in PSA
The primary objective of this study is to determine a correlation between inherited genetic polymorphisms and antitumor activity (as defined by a decline in PSA of ≥ 30%) in AA patients with castration-resistant prostate cancer treated with Abiraterone. The primary endpoint is the percent change in PSA from baseline to 12 weeks. A decline of ≥ 30% will be correlated with germline SNPs. (NCT01735396)
Timeframe: baseline and 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate | 9 |
Response Assessment
Post-treatment changes in measurable disease by RECIST - Response Evaluation Criteria in Solid Tumors Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (NCT01735396)
Timeframe: up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| PR | SD |
|---|
| Abiraterone Acetate | 9 | 1 |
Safety of Abiraterone
To determine the safety of abiraterone Adverse events as defined by CTCAE v4. Number of participants with serious adverse events grade 4 or 5 (NCT01735396)
Timeframe: up to 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate | 0 |
Progression-free Survival (PFS)
defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (>150 ng/dL) at 18 months from the time of treatment initiation (PSA0). (NCT01751451)
Timeframe: 18 months
| Intervention | percentage change of PSA (Mean) |
|---|
| Abiraterone Acetate | 5.1 |
| Abiraterone Acetate and Degarelix | 17.1 |
| Degarelix | 11.9 |
Progression-Free Survival
Progression-free survival at 3 months. (NCT01845792)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Cabazitaxel With Abiraterone Acetate | 5 |
| Cabazitaxel Alone | 2 |
PSA Response
Prostate specific antigen (PSA) decline by 50% or more from baseline. (NCT01845792)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Cabazitaxel With Abiraterone Acetate | 4 |
| Cabazitaxel Alone | 0 |
Phase I: Frequency of Dose Limiting Toxicities of Alisertib, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.1
Summarized with descriptive statistics. (NCT01848067)
Timeframe: Up to 21 days
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Alisertib, Abiraterone Acetate, Prednisone) | 2 |
Number of Participants With a PSA Value Equal to or Greater Than 25%
Compared between the two patient subsets using the nonparametric Mann-Whitney test. A comparison of CTC counts between baseline and at progression for those who have progressed will be carried out using either a paired t test or the nonparameteric Wilcoxon matched pairs test. (NCT01848067)
Timeframe: Baseline up to 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Alisertib, Abiraterone Acetate, Prednisone) | 3 |
Time to Prostate-Specific Antigen (PSA) Progression
Time to PSA progression was defined as time interval from the date of randomization to the date of the first prostate-specific antigen (PSA) progression as defined in the protocol-specific Prostate Specific Antigen Working Group 2 (PSAWG2) criteria during the main study treatment period. PCWG2 defines PSA progression as the date that a 25 percent (%) or greater increase and an absolute increase of 2 nanogram per milliliter (ng/mL) or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later. (NCT01867710)
Timeframe: Up to 156 weeks
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 10.38 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 10.22 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 4.83 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 18.56 |
Change From Baseline to Endpoint in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire Score
FACT-P is a 39-item participant rated questionnaire which consists of 5 subscales assessing physical well-being (7 items; score range 0-28), social/family well-being (7 items; score range 0-28), emotional well-being (6 items; score range 0-24), functional well-being (7 items; score range 0-28), prostate-specific concerns (12 items; score range 0-48). Each item rated on 0 to 4 Likert type scale, then combined to produce subscale scores for each domain, as well as global quality of life (QoL) score that ranges from 0 to 156. Higher scores represent better QoL. Additional Concerns subscale has 12 items, each with a score 0-6 making a total subscale range 0-72 (higher scores are better). Missing data imputed as per FACT-P Ver4 scoring system (sum of item scores*number of items in subscale/number of items answered). (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
| Intervention | Units on a scale (Mean) |
|---|
| Physical Well-Being | Social/Family Well-Being | Emotional Well-Being | Functional Well-Being | Global Score | Additional Concerns |
|---|
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | -1.04 | -1.97 | -0.02 | -2.95 | -5.77 | -0.72 |
,| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | -2.46 | -0.78 | -1.66 | -2.67 | -10.39 | -3.96 |
,| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | -0.98 | -0.01 | -1.46 | -1.13 | -4.73 | -1.29 |
,| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | -2.20 | 0.61 | -0.89 | -2.19 | -6.62 | -2.35 |
Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): EQ-VAS
EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed. (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
| Intervention | Units on a scale (Mean) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | -4.5 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | -5.0 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | -6.6 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | -3.1 |
Change From Baseline to Endpoint in EuroQol-5 Dimension-5 Level (EQ-5D-5L): Index Score
"EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). LOCF approach used for endpoint analysis. Last observation is defined as last visit with non-missing data for parameter analyzed." (NCT01867710)
Timeframe: Baseline up to the Endpoint (last post-baseline assessment value during 156 weeks of MSTP)
| Intervention | Units on a scale (Mean) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | -0.0694 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | -0.0638 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | -0.0728 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | -0.0359 |
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with measurable disease at baseline achieving a complete response (CR) or partial response (PR) according to modified response evaluation criteria in solid tumors (RECIST) criteria. RECIST criteria for CR: disappearance of all target lesions and non-target lesions , any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 millimetre [mm] short axis). PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. (NCT01867710)
Timeframe: Up to 4.9 years
| Intervention | Percentage of participants (Number) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 42.1 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 38.9 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 60.0 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 56.3 |
Overall Survival
Overall survival was defined as the time interval from the date of randomization to the date of death from any cause. (NCT01867710)
Timeframe: Up to 156 weeks
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 34.07 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 48.43 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 27.96 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 42.81 |
Percentage of Participants Experiencing Neither of the 2 Mineralocorticoid Excess Toxicity During the First 24 Weeks of Treatment
No mineralocorticoid excess is defined as experiencing neither of the 2 mineralocorticoid excess toxicities, that is, neither hypokalemia nor hypertension. (NCT01867710)
Timeframe: Week 24
| Intervention | Percentage of Participants (Number) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 70.6 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 36.8 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 60.0 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 70.3 |
Percentage of Participants With Confirmed Prostate Specific Antigen (PSA) Response Rate [Greater Than or Equal to (>=) 50 Percent (%) Decline From Baseline] at Week 12
The PSA response is defined as a >= 50% decline from baseline according to the adapted Prostate Cancer Working Group 2 (PCWG2) criteria. For a PSA response to be confirmed, an additional PSA measurement obtained 4 or more weeks later has to show >=50% decline from baseline. (NCT01867710)
Timeframe: Week 12
| Intervention | Percentage of Participants (Number) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 57.1 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 70.6 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 47.2 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 79.5 |
Progression-Free Survival (PFS)
PFS: Time from randomization to one of following: radiographic progression (RP), clinical progression (CP) or death. RP- per PCWG2 criteria and modified RECIST as time from randomization to one of following: 1) considered to have progressed by bone scan if: a) first scan with >=2 new lesions compared to baseline at <12 weeks from randomization and confirmed by second scan >=6 weeks later with >=2 additional new lesions, b) first scan with >=2 new lesions compared to baseline at >=12 weeks from randomization and new lesions on next bone scan >=6 weeks later; 2) Progression of soft tissue lesions per modified RECIST; CP: cancer pain requiring initiation of chronic use of opiate analgesia (oral use for >=3 weeks; parenteral use for >=7 days), Or immediate need to initiate cytotoxic chemotherapy or either radiation therapy or surgical intervention for complications due to tumor progression, even in absence of RP, Or deterioration in ECOG performance status to grade 3 or above. (NCT01867710)
Timeframe: Up to 4.9 years
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 16.16 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 12.68 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 8.51 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 21.22 |
Time to Next Prostate Cancer Therapy
Time to next prostate cancer therapy is defined as the time interval from the date of randomization to the date of initiation of first next therapy for prostate cancer. (NCT01867710)
Timeframe: Up to 4.9 years
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg BID | 20.14 |
| Abiraterone Acetate 1000 mg QD + Prednisone 5 mg QD | 19.48 |
| Abiraterone Acetate 1000 mg QD + Prednisone 2.5 mg BID | 16.66 |
| Abiraterone Acetate 1000 mg QD + Dexamethasone 0.5 mg QD | 28.29 |
Percent of Subjects Experiencing Hypertension
Incidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated) (NCT01940276)
Timeframe: up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| All grades | Grades 3 and 4 |
|---|
| Abiraterone Acetate and Prednisone: African American Men | 23 | 12 |
,| Abiraterone Acetate and Prednisone: White Men | 20 | 8 |
Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
Number of men who achieve a PSA decline to < 0.1 and < 0.2 ng/ml (NCT01940276)
Timeframe: up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| PSA decline to < 0.1 | PSA decline to < 0.2 |
|---|
| Abiraterone Acetate and Prednisone: African American Men | 9 | 13 |
,| Abiraterone Acetate and Prednisone: White Men | 4 | 5 |
Change in PSA Response
Percent of men with Prostate Specific Antigen (PSA) declines > 30%, > 50% and > 90% (NCT01940276)
Timeframe: Baseline and up to 2 years
| Intervention | percentage of participants (Number) |
|---|
| Percent of men with PSA declines > 30% | Percent of men with PSA declines > 50% | Percent of men with PSA declines > 90% |
|---|
| Abiraterone Acetate and Prednisone: African American Men | 82 | 74 | 48 |
,| Abiraterone Acetate and Prednisone: White Men | 78 | 66 | 38 |
Overall Survival
Length of patient's life after starting study (NCT01940276)
Timeframe: up to 3 years
| Intervention | months (Median) |
|---|
| Abiraterone Acetate and Prednisone: White Men | 35.7 |
| Abiraterone Acetate and Prednisone: African American Men | 35.9 |
Proportion of Participants With Positive Surgical Margins
The difference in the rate of positive surgical margins between the two groups will be descriptively summarized. (NCT01946165)
Timeframe: For both groups, tumor samples collected at baseline and during surgery.
| Intervention | Participants (Count of Participants) |
|---|
| Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone | 9 |
| Group B: Abiraterone + LHRHa + Prednisone | 2 |
Proportion of Participants With Pathologic Stage Less Than or Equal to ypT2N0
The proportion of participants with pathologic stage less than or equal to ypT2N0 will be descriptively summarized and compared between the two treatment arms. The proportion will be calculated as the number of patients with less than or equal to ypT2N0 in each treatment arm divided by the total number of patients who underwent surgery in the same arm. (NCT01946165)
Timeframe: For all participants who underwent surgery, from start of treatment until surgery is completed
| Intervention | Participants (Count of Participants) |
|---|
| Group A: Abiraterone + Enzalutamide + LHRHa + Prednisone. | 13 |
| Group B: Abiraterone + LHRHa + Prednisone | 11 |
Safety and Tolerability
Number of Participants with Adverse Events (NCT01994590)
Timeframe: Participants are followed while actively taking study drug and for at least 30 days post last dose.
| Intervention | Participants (Count of Participants) |
|---|
| All Patients | 4 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 20.2 | -1.0 | -1.2 | -1.3 | -1.2 | -1.0 | -2.4 | -2.0 | -1.5 | -2.1 | -2.0 | -2.1 | -1.6 | -1.4 | -0.8 | -1.2 | 0.2 | -0.6 | -1.6 | -1.5 | -1.5 | 1.0 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Functional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for functional well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 20.3 | -0.7 | -0.4 | -0.5 | -0.7 | -0.3 | -0.2 | -0.7 | 0.2 | 0.8 | -0.3 | 1.5 | 1.3 | 2.0 | 2.9 | 1.7 | 2.3 | 4.0 | 2.5 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 18.1 | -0.1 | -0.1 | -0.2 | 0.3 | 0.3 | -0.5 | 0.1 | -0.7 | 0.1 | -0.5 | 0.0 | 0.1 | -0.4 | -0.3 | -0.9 | -0.5 | 1.0 | 0.1 | 1.5 | -1.5 | -3.0 |
Objective Response Rate (ORR)
Objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumor version 1.1 (RECIST v1.1) was defined as 1) Percentage of participants with confirmed best overall complete response (CR) and partial response (PR); 2) Percentage of participants with CR, PR and stable disease (SD) for target lesions or non-progressive disease for non-target lesions. CR: Disappearance of all non-nodal target and non-target lesions, including target and non-target lymph nodes reduction to <10 millimeter (mm) in short axis. No new lesions and disappearance of all non-target lesions. PR: >= 30% decrease in sum of diameters of target lesions, compared to the sum at baseline. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. (NCT01995513)
Timeframe: From randomization until CR or PR, whichever occurred first (maximum up to 21.3 months)
| Intervention | percentage of participants (Number) |
|---|
| CR + PR | CR + PR + SD |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 0.0 | 68.4 |
,| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 5.0 | 57.5 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Emotional Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for emotional well-being domain is from 0 (worst response) to 24 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 18.5 | 0.1 | 0.2 | 0.4 | 0.1 | 0.3 | 0.3 | 0.9 | 0.9 | 1.4 | 1.2 | 1.3 | 1.2 | 1.6 | 1.1 | 2.9 | 1.5 | -5.0 | 2.0 |
Time to Prostate Specific Antigen (PSA) Progression
Time from date of randomization to the date of first confirmed PSA progression as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2). For participant's whose PSA decreased at Week 13 after randomization, progression was defined as 25 percent (%) PSA increase relative to nadir or absolute increase of >=2 nanogram/milliliter (ng/mL) above nadir. Progression was confirmed if another assessment measured at least 3 weeks later met the criterion as well. For participant's whose PSA did not decrease at Week 13 after randomization, progression was defined as 25% PSA increase relative to baseline assessed 12 weeks after baseline. Participants who were not known to have had a PFS event at the analysis date were censored at last PSA assessment date prior to data cutoff date. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
| Intervention | months (Median) |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 2.8 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.8 |
Time to First Use of New Antineoplastic Therapy for Prostate Cancer
It was defined as time from randomization to the date of first use of subsequent antineoplastic therapy for prostate cancer. For participants who had not started subsequent antineoplastic therapy as of data analysis cutoff date, the time to first use of subsequent antineoplastic therapy was censored at the date of last assessment. (NCT01995513)
Timeframe: From randomization until date of first use of any antineoplastic therapy (after last dose date of Period 2, maximum up to 22.3 months
| Intervention | months (Median) |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 10.3 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 8.6 |
Time to Degradation of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
Time to degradation of FACT-P was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the global FACT-P score for each participant. The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, and functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 with higher scores representing better quality of life. Participants with no score degradation at the time of analysis data cutoff were censored at the date of last assessment showing no degradation. (NCT01995513)
Timeframe: From randomization up to maximum of 18.4 months
| Intervention | months (Median) |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 4.6 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 6.4 |
Rate of Pain Progression
Rate of pain progression was defined as percentage of participants with an increase of >=30% from baseline in the mean Brief Pain Inventory-Short Form (BPI-SF) pain intensity item scores of 4 items assessing average, worst, least, and intermediate pain severity. BPI-SF is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions of a participant. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf score range for each item was from 0=no pain to 10=worst possible pain. Total score was reported as average of individual questions ranges from 0 to 10, where lower scores indicated less pain or less pain interference. (NCT01995513)
Timeframe: Month 6
| Intervention | percentage of participants (Number) |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 36.2 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 27.1 |
Progression Free Survival (PFS)
PFS = time from randomization to first documentation of radiographic progression (RP),unequivocal clinical progression or death due to any cause (death within 112 days of treatment discontinuation without objective evidence of RP),whichever occurred first as per investigator. Unequivocal disease progression was pain requiring chronic administration of analgesics, decline of prostate cancer of Eastern Cooperative Oncology Group (ECOG) performance status score to 3 or higher or initiation of new anticancer therapy/radiation therapy or surgical intervention due to tumor progression. ECOG score range= 0(no severity) to 5(maximum severity).RP for bone disease was evaluated by appearance of 2 or more new bone lesions as per Prostate Cancer Clinical Trials Working Group 2 (PCWG2) or for soft tissue disease according to Response Evaluation Criteria in Solid Tumor version 1.1. Participants with no PFS event at analysis date were censored at last tumor assessment date prior to data cutoff date. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression or death due to any cause, whichever occurred first (maximum up to 20.3 months)
| Intervention | months (Median) |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 5.7 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 5.6 |
Percentage of Participants With Adverse Events (AEs) Leading to Death
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
| Intervention | percentage of participants (Number) |
|---|
| Enzalutamide 160 mg | 5.9 |
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 0 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 3.2 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.4 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 (n =17, 13) | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 116.4 | -3.3 | -4.4 | -3.7 | -2.5 | -3.1 | -6.8 | -5.9 | -6.1 | -5.7 | -6.0 | -4.2 | -4.8 | -4.3 | -5.5 | -7.0 | -3.5 | -0.7 | -4.0 | 10.8 | -5.5 | -2.0 |
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
| Intervention | percentage of participants (Number) |
|---|
| Drug Discontinuation with Enzalutamide or Placebo | Drug Discontinuation with Abiraterone | Drug Discontinuation with Prednisone |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 23.2 | 23.2 | 16.0 |
,| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 11.3 | 12.9 | 12.1 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which is the sum of all 5 domain scores and ranges from 0 to 156 where higher scores represent better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 (n =17, 13) | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 119.0 | -2.2 | -0.5 | -2.3 | -2.7 | -2.1 | 0.3 | -0.2 | 0.9 | 1.3 | -2.6 | 1.8 | 1.8 | 0.1 | 0.6 | 1.9 | 4.4 | -35.0 | 6.5 |
Prostate Specific Antigen (PSA) Response Rate
PSA response rate was defined as percentage of participants with >=30% and >=50% decrease in PSA from baseline at randomization to the maximal PSA response with a threshold of 30% and 50% respectively. PSA response was confirmed if another assessment measured at least 3 weeks later met the criterion as well. (NCT01995513)
Timeframe: From randomization until disease progression, last tumor assessment without disease progression, whichever occurred first (maximum up to 11.1 months)
| Intervention | percentage of participants (Number) |
|---|
| >= 50% | >= 30% |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 0.8 | 2.4 |
,| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 2.5 | 2.5 |
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
| Intervention | percentage of participants (Number) |
|---|
| AEs | SAEs |
|---|
| Enzalutamide 160 mg | 93.5 | 32.0 |
,| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 91.2 | 37.6 |
,| Enzalutamide Crossing Over to Abiraterone + Prednisone | 100 | 30.8 |
,| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 92.7 | 29.8 |
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
| Intervention | percentage of participants (Number) |
|---|
| Drug Discontinuation with Abiraterone | Drug Discontinuation with Prednisone |
|---|
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 7.7 | 7.7 |
Percentage of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by the investigator: 'Is the AE leading to study discontinuation or death?' as 'yes'. (NCT01995513)
Timeframe: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
| Intervention | percentage of participants (Number) |
|---|
| Drug Discontinuation with Enzalutamide or Placebo |
|---|
| Enzalutamide 160 mg | 11.8 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 22.1 | -0.5 | -0.4 | -0.1 | -0.5 | 0.1 | -0.1 | -0.2 | -0.8 | -1.4 | -0.9 | -0.6 | -1.0 | -2.0 | -1.5 | -1.5 | -1.4 | -0.6 | -0.9 | 6.2 | -1.0 | 0.0 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Social/Family Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for social/family well-being domain is from 0 (worst response) to 32 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 22.4 | -0.8 | -0.4 | -0.6 | -1.2 | -1.0 | -0.2 | 0.0 | 0.8 | -0.1 | -0.8 | 0.0 | 0.4 | 0.2 | -0.2 | -0.5 | -0.5 | -1.0 | -0.5 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 33.2 | -0.7 | -1.9 | -1.0 | -0.4 | -0.8 | -1.3 | -1.4 | -1.5 | -1.0 | -0.8 | -0.8 | -1.1 | -0.5 | -2.1 | -2.0 | -1.5 | -0.2 | -1.0 | 3.1 | -0.5 | 0.0 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Prostate Cancer Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for prostate cancer domain is from 0 (worst response) to 48 (best response), where higher score indicated better quality of life with fewer symptoms. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 34.2 | -0.9 | -0.1 | -1.4 | -0.6 | -0.8 | -0.3 | -0.6 | -0.8 | -0.7 | -1.7 | -0.9 | -1.8 | -3.3 | -3.1 | -2.6 | 1.1 | -6.4 | -1.5 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 | Change at Week 81 | Change at Week 85 | Change at Week 89 |
|---|
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 22.9 | -0.8 | -1.0 | -1.1 | -0.8 | -1.7 | -2.5 | -2.5 | -1.8 | -1.5 | -2.0 | -0.9 | -0.2 | -0.4 | -0.8 | -1.9 | -0.3 | -0.3 | -0.7 | 1.5 | -1.0 | 0.0 |
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Physical Well-Being Domain Scores
The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life. (NCT01995513)
Timeframe: Baseline, Week 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57, 61, 65, 69, 73, 77, 81, 85, 89
| Intervention | units on a scale (Mean) |
|---|
| Baseline | Change at Week 9 | Change at Week 13 | Change at Week 17 | Change at Week 21 | Change at Week 25 | Change at Week 29 | Change at Week 33 | Change at Week 37 | Change at Week 41 | Change at Week 45 | Change at Week 49 | Change at Week 53 | Change at Week 57 | Change at Week 61 | Change at Week 65 | Change at Week 69 | Change at Week 73 | Change at Week 77 |
|---|
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 23.6 | 0.1 | 0.0 | -0.3 | -0.8 | -0.4 | 0.3 | 0.1 | 0.4 | 0.4 | -0.4 | 0.6 | 0.7 | 0.4 | 0.4 | 0.4 | -0.5 | -3.0 | 4.0 |
Number of Participants With Toxicities That Required the Addition of Prednisone to Manage Symptoms of Persistent or Severe Mineralocorticoid Excess
Patients requiring prednisone to manage toxicities such as COU-302 any grade or COU-301 grade 3-4 hypertension, hypokalemia and edema per CTCAE v. 4.0 were summarized using frequency and percentage. (NCT02025010)
Timeframe: Patients were on abiraterone acetate up to 57 months and toxicities of mineralocorticoid excess were monitored each cycle (1cycle = 28 days).
| Intervention | Participants (Count of Participants) |
|---|
| Any grade mineralocorticoid toxicities | Any grade hypertension | Any grade hypokalemia | Any grade edema | Grade 3-4 mineralocorticoid toxicities | Grade 3-4 hypertension | Grade 3-4 hypokalemia | Grade 3-4 edema |
|---|
| Abiraterone Acetate | 38 | 28 | 15 | 11 | 12 | 9 | 4 | 0 |
Percent Changes in Serum Concentrations of Androgen (Including Testosterone, DHT and Androgen Precursors) Between Cycle 1 and Cycle 2.
Change in corticosterone level between cycle 2 and cycle 1 was summarized by whether patients initiated prednisone for hypertension and hypokalemia. (NCT02025010)
Timeframe: 1 month
| Intervention | Percent change (Median) |
|---|
| Androstenedione change among patients without prednisone | Androstenedione change among patients with prednisone | Androsterone change among patients without prednisone | Androsterone change among patients with prednisone | Corticosterone change among patients without prednisone | Corticosterone change among patients with prednisone | Cortisol change among patients without prednisone | Cortisol change among patients with prednisone | DHEA change among patients without prednisone | DHEA change among patients with prednisone | DHT change among patients without prednisone | DHT change among patients with prednisone | 11 Deoxycorticosterone change among patients without prednisone | 11 Deoxycorticosterone change among patients with prednisone | 11 Deoxycortisol change among patients without prednisone | 11 Deoxycortisol % change among patients with prednisone | 17 Hydroxypregnenolone % change among patients without prednisone | 17 Hydroxypregnenolone % change among patients with prednisone | 17 Hydroxyprogesterone change among patients without prednisone | 17 Hydroxyprogesterone change among patients with prednisone | Pregnenolone change among patients without prednisone | Pregnenolone change among patients with prednisone | Progesterone change among patients without prednisone | Progesterone change among patients with prednisone | Testosterone change among patients without prednisone | Testosterone change among patients with prednisone |
|---|
| Abiraterone Acetate | -0.97 | -0.97 | -0.91 | -0.87 | 42.7 | 51.7 | -0.58 | -0.73 | -0.98 | -0.99 | -0.37 | -0.29 | 40.3 | 47.8 | -0.61 | -0.71 | 0 | 0 | 0.02 | 0.06 | 19.0 | 23.4 | 96.3 | 104.6 | 0.07 | 0.07 |
Changes in BMI Between Cycle 1 and Next Cycle
Changes in BMI between cycle 1 and cycle 2 were summarized descriptively. (NCT02025010)
Timeframe: 1 month
| Intervention | kg/m² (Median) |
|---|
| Abiraterone Acetate | 0 |
Changes in Hemoglobin-A1c Between Cycle 1 and Next Cycle (Cycle 4)
Changes in HbA1c at cycle 1 and next measurement at cycle 4 were summarized descriptively. (NCT02025010)
Timeframe: 3 months
| Intervention | Percentage of glycated hemoglobin (Median) |
|---|
| Abiraterone Acetate | 0 |
Changes in Serum Concentrations of ACTH Between Cycle 1 and Cycle 2.
Changes in serum concentrations of ACTH at second assessment referent to the value at the first visit were summarized descriptively. (NCT02025010)
Timeframe: 1 month
| Intervention | pg/mL (Median) |
|---|
| Abiraterone Acetate | 0 |
Number of Participants Requiring the Addition of Prednisone to Manage Symptoms of Severe Fatigue.
Participants initiated treatment with prednisone for ≥grade 3 fatigue were summarized using frequency and percentage. (NCT02025010)
Timeframe: Patients were on abiraterone acetate up to 57 months.
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate | 1 |
Number of Patients Who Progressed With Measurable Disease at Pre-study Among Those Who Were Added of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
Radiographic response of measurable disease is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease. Due to small number patients, patients who experienced progressive disease were summarized using frequency and time to progression using Kaplan-Meier method was not calculated. (NCT02025010)
Timeframe: Imaging was performed every 12 weeks up to 23 months.
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate | 6 |
Number of Patients Who Received AA Monotherapy and Progressed With Measurable Disease at Pre-study
Radiographic disease progression is defined using RECIST v 1.1 for soft-tissue and visceral disease and PCWG2 for bone disease (2 or more new lesions on bone scan and for the first 12-week assessment, defining disease progression requires a confirmatory scan performed 6 or more weeks later which shows a minimum of 2 additional new lesions). (NCT02025010)
Timeframe: Imaging was performed every 12 weeks up to 23 months.
| Intervention | Participants (Count of Participants) |
|---|
| Abiraterone Acetate | 5 |
PSA Response and Its Duration to AA Monotherapy.
PSA response was defined per PCWG2 criteria (PSA reduction of ≥50%) and duration of PSA response is defined as time from PSA response to PSA progression or death, whichever occurs first. (NCT02025010)
Timeframe: PSA was measured every cycle (up to 25 months)
| Intervention | months (Median) |
|---|
| Abiraterone Acetate | 3 |
PSA Response and Its Duration to Addition of Prednisone to AA at Time of PSA Progression on AA Monotherapy.
Among those who initiated prednisone due to PSA progression, duration of PSA response was calculated as time from PSA response (PSA reduction ≥50%) to PSA progression or death, whichever occurs first. (NCT02025010)
Timeframe: PSA was measured every cycle (up to 25 months)
| Intervention | months (Median) |
|---|
| Abiraterone Acetate | 5 |
Symptomatic Skeletal Event-free Survival
(NCT02034552)
Timeframe: From the randomization date to the first SSE on or following the randomization date or death, whichever occurred first (about 32.39 months)
| Intervention | Months (Median) |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 11.93 |
| Radium-223 With Abiraterone & Prednision | NA |
| Radium-223 With Enzalutamide | 19.91 |
Time to First Symptomatic Skeletal Event
(NCT02034552)
Timeframe: From the randomization date to the first SSE on or following the randomization date (about 30.82 months)
| Intervention | Months (Median) |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | NA |
| Radium-223 With Abiraterone & Prednision | NA |
| Radium-223 With Enzalutamide | NA |
Time to Radiological Bone Progression
(NCT02034552)
Timeframe: From the randomization date to the date of radiological bone progression (about 30.82 months)
| Intervention | Months (Median) |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 11.5 |
| Radium-223 With Abiraterone & Prednision | NA |
| Radium-223 With Enzalutamide | NA |
Time to Radiological Progression
(NCT02034552)
Timeframe: From the randomization date to the date of radiological disease progression (about 30.82months)
| Intervention | Months (Median) |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 4.40 |
| Radium-223 With Abiraterone & Prednision | NA |
| Radium-223 With Enzalutamide | NA |
Patient Bone Scan Response Rate
Radiological bone scan response based on change from baseline of digitized technetium-99 bone scans using computer-aided detection software. Responder (R): 30% or greater resolution of the BSLA compared to baseline. Stable Disease (SD): Not meeting the criteria for R, PD, or UE. Progressive Disease (PD): Two or more new areas of radiotracer uptake attributable to metastatic disease in regions of bone that had not previously shown radiotracer uptake or greater than 30% increase from baseline in BSLA attributable to metastatic disease. Unable to Evaluate (UE): Assigned if bone scan results cannot be interpreted due to inconsistent image acquisition parameters compared to the reference scan, incomplete imaging, or other similar technical deficiencies. (NCT02034552)
Timeframe: At 24 weeks
| Intervention | Percentage (Number) |
|---|
| Responder (R) | Stable Disease (SD) | Progressive Disease (PD) | Missing |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 22.2 | 0 | 27.8 | 50.0 |
,| Radium-223 With Abiraterone & Prednision | 57.9 | 21.1 | 5.3 | 15.8 |
,| Radium-223 With Enzalutamide | 50.0 | 18.8 | 12.5 | 18.8 |
Radiological Progression Free Survival
(NCT02034552)
Timeframe: From randomization to radiological disease progression or death from any cause (about 30.82 months )
| Intervention | Months (Median) |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 4.40 |
| Radium-223 With Abiraterone & Prednision | NA |
| Radium-223 With Enzalutamide | NA |
Overall Survival
(NCT02034552)
Timeframe: From the randomization date to the date of death due to any cause (about 42.94 months)
| Intervention | Months (Median) |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 35.81 |
| Radium-223 With Abiraterone & Prednision | 37.55 |
| Radium-223 With Enzalutamide | 29.86 |
Bone Scan Lesion Area
Bone scan lesion area was defined as the sum of the pixel areas (cm2) of the set of the whole body technetium-99 bone scan imaging pixels identified as bone lesion. (NCT02034552)
Timeframe: At 24 weeks
| Intervention | cm^2 (Mean) |
|---|
| Radium-223 Dichloride (Xofigo, BAY88-8223) | 30227.13 |
| Radium-223 With Abiraterone & Prednision | 10185.58 |
| Radium-223 With Enzalutamide | 17321.45 |
Disease Response as Defined by RECIST 1.1 (Soft Tissue Lesions) and PCWG2 Criteria (Bone Lesions)
Number of participants with complete or partial response post-BAT as defined by RECIST 1.1 (for soft tissue lesions) and PCWG2 criteria (for bone disease), or return to castration-only post-BAT. (NCT02090114)
Timeframe: up to 18 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A:Post-enzalutamide | 6 |
| Cohort B: Post-abiraterone | 2 |
| Cohort C: Castration Only | 4 |
| Cohort D: Mutation | 0 |
PSA Progression on Enzalutamide or Abiraterone Acetate or Castrate Levels Post-BAT
Time to PSA progression on enzalutamide or abiraterone acetate or return to castrate levels of testosterone post-BAT, defined as the time from the date of re-initiation of enzalutamide or abiraterone acetate or castration-only therapy to the date of the PSA measurement when it shows an increase by ≥25% above the nadir value that occurred following re-initiation of enzalutamide or abiraterone acetate or castration-only therapy and confirmed by a repeat PSA 4 weeks later (PCWG2). (NCT02090114)
Timeframe: up to 18 months
| Intervention | months (Median) |
|---|
| Cohort A:Post-enzalutamide | 5.5 |
| Cohort B: Post-abiraterone | 3.7 |
| Cohort C: Castration Only | NA |
Safety and Tolerability as Assessed by Number of Participants With Adverse Events
Number of participants who experience adverse events, as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. (NCT02090114)
Timeframe: 18 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A:Post-enzalutamide | 30 |
| Cohort B: Post-abiraterone | 29 |
| Cohort C: Castration Only | 29 |
| Cohort D: Mutation | 7 |
PSA Progression on BAT (Bipolar Androgen Therapy )
Time to PSA progression on BAT. Time to PSA progression on BAT is defined as the time from the date of initial dose of Testosterone to the date of the PSA measurement when it shows an ≥25% increase above the nadir value and confirmed by a repeat PSA 4 weeks later (PCWG2 criteria) during the treatment with BAT. (NCT02090114)
Timeframe: up to 18 months
| Intervention | months (Median) |
|---|
| Cohort A:Post-enzalutamide | 3.3 |
| Cohort B: Post-abiraterone | 3.2 |
| Cohort C: Castration Only | 0.93 |
| Cohort D: Mutation | 3 |
Quality of Life (QoL) as Assessed by IIEF
International Index of Erectile Function (IIEF-5) is a diagnostic tool for erectile dysfunction, with a total score range of 5-25, with the lowest score indicating a higher degree of dysfunction. (NCT02090114)
Timeframe: up to 18 months
| Intervention | score on a scale (Mean) |
|---|
| Baseline | BAT C1D85 |
|---|
| Cohort A:Post-enzalutamide | 8 | 24.13 |
,| Cohort B: Post-abiraterone | 7.33 | 24.94 |
,| Cohort C: Castration Only | 12.56 | 22.44 |
Quality of Life (QoL) as Assessed by RANDSF-36
RAND 36-Item Short Form (RANDSF-36) assesses physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, general health perceptions, and perceived change in health with a total score range of 0-100. The total score from all of the questions answered is divided by the total number of the questions answered yielding a global score from 0-100, with a higher score reflecting a better QoL. (NCT02090114)
Timeframe: up to 18 months
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Cycle 1 Day 85 |
|---|
| Cohort A:Post-enzalutamide | 72.23 | 71.76 |
,| Cohort B: Post-abiraterone | 64.36 | 73.97 |
,| Cohort C: Castration Only | 69.72 | 73.40 |
Quality of Life (QoL) as Assessed by FACIT-F Score
Functional Assessment of Chronic Illness Therapy, Fatigue Subscale (FACIT-F) assesses Fatigue with a total score range of 0-52, with a higher score reflecting better QoL. (NCT02090114)
Timeframe: up to 18 months
| Intervention | score on a scale (Mean) |
|---|
| Baseline | Cycle 1 Day 85 |
|---|
| Cohort A:Post-enzalutamide | 13.28 | 10.64 |
,| Cohort B: Post-abiraterone | 16.86 | 13.85 |
,| Cohort C: Castration Only | 13 | 11.55 |
Quality of Life (QoL) as Assessed by PANAS
Positive and Negative Affect Schedule (PANAS) is a self-report measure that is made up of two mood scales, one measuring positive affect and the other measuring negative affect, with a total score range from 10-50 with a higher score on the positive scale indicating greater levels of positive affect and a lower score on the negative scale indicating less of a negative affect. (NCT02090114)
Timeframe: up to 18 months
| Intervention | score on a scale (Mean) |
|---|
| Baseline | BAT C1D85 |
|---|
| Cohort A:Post-enzalutamide | 46.15 | 45.1 |
,| Cohort B: Post-abiraterone | 48 | 45.22 |
,| Cohort C: Castration Only | 41.24 | 44.48 |
Prostate Specific Antigen (PSA) Response to Bipolar Androgen Therapy (BAT)
Number of participants with ≥50% PSA reduction from pre-BAT baseline level (NCT02090114)
Timeframe: up to 18 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A:Post-enzalutamide | 9 |
| Cohort B: Post-abiraterone | 5 |
| Cohort C: Castration Only | 4 |
| Cohort D: Mutation | 2 |
PSA Response to Enzalutamide or Abiraterone Acetate Post Bipolar Androgen Therapy
Number of participants with ≥50% PSA reduction after enzalutamide or abiraterone acetate post-BAT from baseline (NCT02090114)
Timeframe: up to 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort A:Post-enzalutamide | 15 |
| Cohort B: Post-abiraterone | 3 |
| Cohort D: Mutation | 2 |
Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment
[Not Specified] (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
| Intervention | Lesions (Mean) |
|---|
| Baseline | EOT |
|---|
| Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 11.6 | 5.6 |
Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported.
All adverse events relevant to advanced mCRPC subjects as well as adverse events of interest for both Abiraterone Acetate plus Prednisone and Radium Ra 223 dichloride will be reported. (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.
| Intervention | Adverse Events (Number) |
|---|
| Overall Adverse Events | Grade I or II Adverse Events | Treatment Related Adverse Events |
|---|
| Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 186 | 179 | 70 |
Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)
"Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI)~Pain Severity: Pain severity is the composite of scores of worst pain, least pain, average pain, and pain now. CMI criteria: Decrease >30% at two consecutive visits in Pain Severity Score in 24 hours without an increase in analgesic use.~Pain interference: Pain interference is the composite scores on general activity, mood, walking ability, normal work, relationships with others, sleep and enjoyment of life. CMI criteria: Decrease by 1.25 points or more compared with baseline at two consecutive visits.~Transient Pain Flare: Based on the work of Atkinson et al, a transient pain flare was assessed by pain at its worst in 24 hours. CMI criteria: > 2 points on the BPI-SF Worst Pain scale and subsequent reduction after initiation of Ra-223 and during the first 3 cycles." (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.
| Intervention | Participants (Count of Participants) |
|---|
| Pain Severity | Pain Interference | Transient Pain Flare |
|---|
| Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 18 | 12 | 2 |
Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment
[Not specified] (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
| Intervention | ng/dL (Mean) |
|---|
| ALP (Baseline) | ALP (EOT) | PSA (Baseline) | PSA (EOT) |
|---|
| Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 261 | 110 | 87 | 137 |
Bone Imaging Response (Number of Participants With Progression and Stable Disease)
Bone imaging response was assessed at baseline and at EOT visit. Progression was defined as two or more additional lesions in comparison to the baseline. (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
| Intervention | Participants (Count of Participants) |
|---|
| Stable Disease | Progression |
|---|
| Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 29 | 2 |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria
"Following Quality of Life questionnaires were given at each visit:~FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the PCS (Range 1-156, higher scores better).~The FACT-General (FACT-G) is a 28 item QOL measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), Emotional (0-24) Well-being, and Satisfaction with Treatment was not assessed for this study (The total range was between 1-108, higher scores better)~FACT-TOI is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better)~PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better)." (NCT02097303)
Timeframe: Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects.
| Intervention | Participants (Count of Participants) |
|---|
| FACT-P Total Scale | FACT-G Total Scale | Treatment Outcome Index (FACT-TOI) | Prostate Cancer Subscale (PCS) | Physical Well-being | Functional Well-being | Emotional Well-being | Social Well-being |
|---|
| Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 20 | 18 | 18 | 25 | 19 | 17 | 18 | 15 |
Overall Response Rate
Determination of measurable disease progression or response was based on modified RECIST criteria. Reported is the number of participants with either a partial or complete response, and who had radiological extraskeletal progression. (NCT02097303)
Timeframe: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
| Intervention | Participants (Count of Participants) |
|---|
| Partial or complete response | Progression |
|---|
| Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 4 | 8 |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who will receive study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly. (NCT02217566)
Timeframe: Up to 4 years
| Intervention | Participants (Count of Participants) |
|---|
| Participants with AEs | Participants with SAEs |
|---|
| Abiraterone Acetate | 45 | 11 |
Percentage of Participants Who Achieved Prostate-Specific Antigen (PSA) Response
The PSA response according to Prostate Specific Antigen Working Group 3 criteria was defined as at least 50% decrease in PSA level from Baseline. (NCT02217566)
Timeframe: Week 12 to any time up to 2 years
| Intervention | Percentage of participants (Number) |
|---|
| Abiraterone Acetate | 57.50 |
Overall Survival
Overall survival was defined as the time from date of the first dose of abiraterone acetate to the date of death due to any cause. For participants who did not die until the time of analysis, survival time was censored at the time of last contact alive. (NCT02217566)
Timeframe: Up to 4 years
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate | 29.6 |
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression was calculated from date of enrollment to the date of first documentation of PSA progression. As per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria, PSA progression was defined as greater than or equal to (>=) 25 percent (%) and >=2 nanogram/milliliter (ng/mL) after 12 weeks (in case of no decline in PSA from Baseline), or first PSA increase that is >=25% and >=2 ng/mL above the nadir, and which was confirmed by a second value 3 or more weeks later (in case of decline of PSA from Baseline). (NCT02217566)
Timeframe: Up to 2 years
| Intervention | Months (Median) |
|---|
| Abiraterone Acetate | 7.3 |
Time to Chronic Opioid Use
Time to chronic opioid use was defined as the time from date of randomization to the first date of opioid use. (NCT02257736)
Timeframe: Up to 5 years and 10 months
| Intervention | months (Median) |
|---|
| Placebo+ Abiraterone Acetate - Prednisolone | 53.26 |
| Apalutamide + Abiraterone Acetate - Prednisolone | 46.98 |
Time to Initiation of Cytotoxic Chemotherapy
Time to initiation of cytotoxic chemotherapy was defined as the time from date of randomization to the date of initiation of cytotoxic chemotherapy. (NCT02257736)
Timeframe: Up to 5 years and 10 months
| Intervention | months (Median) |
|---|
| Placebo+ Abiraterone Acetate - Prednisolone | 34.23 |
| Apalutamide + Abiraterone Acetate - Prednisolone | 36.11 |
Time to Pain Progression
"Time to pain progression: time from randomization to first date that participant either experienced an increase by 2 points from baseline in Brief Pain Inventory Short Form (BPI-SF) worst pain intensity item (item 3) or Case Report Form (CRF) pain, observed at 2 consecutive evaluations >=4 wks apart, or initiation of chronic opioids as defined in time to chronic opioid use, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3(worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where 0 indicates No pain and 10 indicates Pain as bad as you can imagine. A lower score is better.CRF pain refers to participant's response to global pain assessment How would you rate your pain over the past 7 days?with a scale of 0(No pain) to 10(Pain as bad as you can imagine),that is systematically reported and recorded on the eCRF." (NCT02257736)
Timeframe: Up to 5 years and 10 months
| Intervention | months (Median) |
|---|
| Placebo+ Abiraterone Acetate - Prednisolone | 26.51 |
| Apalutamide + Abiraterone Acetate - Prednisolone | 21.82 |
Overall Survival (OS)
The OS was defined as the time from randomization to date of death from any cause. (NCT02257736)
Timeframe: Up to 5 years and 10 months
| Intervention | months (Median) |
|---|
| Placebo+ Abiraterone Acetate - Prednisolone | 33.71 |
| Apalutamide + Abiraterone Acetate - Prednisolone | 36.17 |
Radiographic Progression-free Survival (rPFS)
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (>=) 2 new lesions compared to baseline was observed in less than (<) 12 weeks from randomization and was confirmed by a second bone scan taken >=6 weeks later showing >=2 additional new lesions (a total of >=4 new lesions compared to baseline), b) the first bone scan with >=2 new lesions compared to baseline was observed in >=12 weeks from randomization and the new lesions were verified on the next bone scan >=6 weeks later (a total of >=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. (NCT02257736)
Timeframe: Up to 3 years and 4 months
| Intervention | months (Median) |
|---|
| Placebo+ Abiraterone Acetate - Prednisolone | 16.59 |
| Apalutamide + Abiraterone Acetate - Prednisolone | 23.98 |
Residual Cancer Burden (RCB)
RCB was analyzed using radical prostatectomy (RP) tissue. The largest area of tumor was measured by ruler and the longest tumor dimension in this area was used as the dimension for calculation. (NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry
| Intervention | cm (Median) |
|---|
| ARM 1 | 0.03 |
| ARM 2 | 0.05 |
Percentage of Participants With Pathologic Complete Response (pCR) or Minimal Residual Disease (MRD)
pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. MRD is defined as the largest cross-sectional dimension of residual tumor measuring NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry
| Intervention | percentage of participants (Number) |
|---|
| ARM 1 | 30 |
| ARM 2 | 16 |
Participants With Pathologic Complete Response (pCR)
pCR is defined as the absence of morphologically identifiable carcinoma in the radical prostatectomy (RP) specimen. (NCT02268175)
Timeframe: after RP approximately 24 weeks from study entry
| Intervention | Participants (Count of Participants) |
|---|
| ARM 1 | 5 |
| ARM 2 | 2 |
Overall Survival (OS)
Overall survival was defined as the time interval (in months) from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive, or at the cut-off date whichever comes first. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization to death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Cabazitaxel | 13.6 |
| Abiraterone Acetate or Enzalutamide | 11.0 |
Number of Symptomatic Skeletal Events (SSE)
SSE was defined as occurrence of a new symptomatic pathological fracture, use of external beam radiation to relieve bone pain, occurrence of spinal cord compression or tumor- related orthopedic surgical intervention. (NCT02485691)
Timeframe: Baseline until occurrence of first SSE or data cut-off, whichever comes first (maximum duration: up to 141 weeks)
| Intervention | events (Number) |
|---|
| Cabazitaxel | 24 |
| Abiraterone Acetate or Enzalutamide | 35 |
Duration of Tumor Response
Duration of tumor response was defined as the time (in months) from date of first response (CR or PR) until date of first documentation of tumor progression or death, whichever occurs first. As per RECIST 1.1 CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progression was defined as at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From the date of the first response to the date of first documented tumor progression, or death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Cabazitaxel | 6.5 |
| Abiraterone Acetate or Enzalutamide | 8.0 |
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Utility Single Index and Visual Analogue Scale (VAS) Scores at Cycle 2, 3, 4, 5, 6, 7, 8 and End of Treatment
EQ-5D was a standardized HRQOL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D descriptive system comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels (no problem, some problems & severe problems) within a particular EQ-5D dimension. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS scale ranging from 0-100, where 0=worst imaginable health state and 100=best imaginable health state, where higher states indicated better outcomes. Baseline corresponded to last evaluable assessment before treatment administration. (NCT02485691)
Timeframe: Baseline, Day 1 of each Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6, Cycle 7, Cycle 8 and at End of Treatment (any time up to: 141 weeks)
| Intervention | score on a scale (Mean) |
|---|
| Cycle 2: VAS | Cycle 3: VAS | Cycle 4: VAS | Cycle 5: VAS | Cycle 6: VAS | Cycle 7: VAS | Cycle 8: VAS | End of treatment: VAS | Cycle 2: Utility Index Score | Cycle 3: Utility Index Score | Cycle 4: Utility Index Score | Cycle 5: Utility Index Score | Cycle 6: Utility Index Score | Cycle 7: Utility Index Score | Cycle 8: Utility Index Score | End of treatment: Utility Index Score |
|---|
| Abiraterone Acetate or Enzalutamide | 0.9 | 1.5 | -1.1 | 3.2 | -1.5 | -0.2 | 1.2 | -5.9 | -0.010 | -0.011 | -0.002 | -0.035 | -0.000 | 0.024 | -0.014 | -0.079 |
,| Cabazitaxel | 3.6 | 4.5 | 4.6 | 0.6 | -1.3 | 2.9 | 2.8 | -3.3 | 0.026 | 0.041 | 0.051 | 0.027 | 0.015 | 0.029 | 0.008 | -0.048 |
Time to Pain Progression
Time to pain progression was defined as the time duration (in months) between the date of randomization and the date of first documented pain progression. Pain progression, in participants with no pain or stable pain at Baseline was defined as increase of >=30% from baseline in the BPI-SF pain intensity score observed at 2 consecutive evaluations >=3 weeks apart without decrease in analgesic usage score or increase in analgesic usage score (calculated from analgesic use data, with non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points) >=30%. The BPI-SF is a self-administered questionnaire developed to assess the severity of pain on a 0-10 categorical scale where 0=no pain, 10=pain as bad as you can imagine. Higher scores indicated worst outcomes. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: Baseline until pain progression or data cut-off whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Cabazitaxel | NA |
| Abiraterone Acetate or Enzalutamide | 8.5 |
Radiographic Progression-Free Survival (rPFS)
Radiographic progression-free survival: time (in months) from randomization to occurrence of any one of following: radiological tumor progressions using response evaluation criteria in solid tumors (RECIST 1.1), progression of bone lesions using Prostate Cancer Working Group 2 (PCWG2) criteria or occurrence of death due to any cause. Progression as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with >= 2 new lesions compared to Baseline observed less than (<) 12 weeks from randomization and confirmed by a second bone scan performed >=6 weeks; first bone scan with >=2 new lesions compared to Baseline observed >=12 weeks from randomization. In accordance with protocol, data cut-off date for final analysis of this endpoint was the date when 196 rPFS events had occurred. Analysis done by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Cabazitaxel | 8.0 |
| Abiraterone Acetate or Enzalutamide | 3.7 |
Progression Free Survival (PFS)
PFS:time duration (in months) from date of randomization to date of first occurrence of any of following events: radiological tumor progression (RECIST 1.1); progression of bone lesions (PCWG2); symptomatic progression (developing urinary or bowel symptoms; need to change anti-cancer therapy), pain progression or death due to any cause. Tumor Progression(RECIST 1.1): at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesion (PCWG2 criteria): first bone scan with >=2 new lesions compared to Baseline and confirmed by second bone scan performed >=6 weeks later; pain progression: increase by >=30% from Baseline in pain intensity score (calculated using scale ranged from 0=no pain to 5=extreme pain) or increase in analgesic usage score >=30% (calculated from analgesic use data, non-narcotic medications assigned value of 1 point and narcotic medications assigned 4 points). Analyzed by Kaplan-Meier method. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, pain progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Cabazitaxel | 4.4 |
| Abiraterone Acetate or Enzalutamide | 2.7 |
Percentage of Participants With Prostate Specific Antigen (PSA) Response
PSA response was defined as >= 50% decrease from baseline in serum PSA levels, confirmed by a second PSA value at least 3 weeks later. (NCT02485691)
Timeframe: Baseline up to PSA response, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Cabazitaxel | 36.3 |
| Abiraterone Acetate or Enzalutamide | 14.3 |
Percentage of Participants With Overall Objective Tumor Response
Overall objective tumor response was defined as having a partial response (PR) or complete response (CR) according to the RECIST version 1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (NCT02485691)
Timeframe: From randomization until disease progression, death due to any cause or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Cabazitaxel | 36.5 |
| Abiraterone Acetate or Enzalutamide | 11.5 |
Radiographic Progression-Free Survival (rPFS) in Participants With Presence and Absence of Biomarker
Circulating tumor cell (CTC) counts were considered as biomarker in a liquid biopsy. rPFS in participants with presence and absence of subtypes of CTC biomarker i.e. chromosomal instability (CIN) and neuroendocrine (NE) was reported in this outcome measure. rPFS was defined as: time (in months) from randomization to the first occurrence of any one of following: radiological tumor progressions (RECIST1.1), progression of bone lesions (PCWG2 criteria) or death due to any cause. Progression (RECIST1.1): at least a 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Progression of bone lesions (PCWG2 criteria): first bone scan with >= 2 new lesions compared to Baseline observed <12 weeks from randomization and confirmed by a second bone scan performed >=6 weeks later; first bone scan with >=2 new lesions compared to Baseline observed >=12 weeks from randomization and new lesions were verified on next bone scan >= 6 weeks later. (NCT02485691)
Timeframe: From randomization until tumor progression or bone lesion progression, death due to any cause, or data cut-off date whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Presence of CIN | Absence of CIN | Presence of NE | Absence of NE |
|---|
| Abiraterone Acetate or Enzalutamide | 4.2 | 3.4 | 3.9 | 3.5 |
,| Cabazitaxel | 4.2 | 8.5 | 3.0 | 8.2 |
Time to Symptomatic Skeletal Event
Time to SSE was defined as the time duration (in months) between the date of randomization and the date of occurrence of the first SSE. Analysis was performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From date of randomization until first SSE, or data cut-off whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Cabazitaxel | NA |
| Abiraterone Acetate or Enzalutamide | 16.7 |
Time to PSA Progression (TTPP)
TTPP was defined as the time duration (in months) between the date of randomization and the date of first documented PSA progression. PSA progression (as per PCWG 2) was defined as: 1) If decline from Baseline value: an increase of >=25% (at least 2 ng/mL) over the nadir value, confirmed by a second PSA value at least 3 weeks apart; 2) If no decline from Baseline value: an increase of >=25% (at least 2 ng/mL) over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart. Analysis performed by Kaplan-Meier method. (NCT02485691)
Timeframe: From time from randomization until PSA progression, death due to any cause or data cut-off whichever comes first (maximum duration: up to 141 weeks)
| Intervention | months (Median) |
|---|
| Cabazitaxel | 6.3 |
| Abiraterone Acetate or Enzalutamide | 2.1 |
AUC (0-24 hr)
Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr). (NCT02737332)
Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose
| Intervention | ng*hr/mL (Least Squares Mean) |
|---|
| Zytiga® (Abiraterone Acetate) | 870.859 |
| SoluMatrix™ (Abiraterone Acetate) | 626.066 |
Cmax
Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr). (NCT02737332)
Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose
| Intervention | ng/mL (Least Squares Mean) |
|---|
| Zytiga® (Abiraterone Acetate) | 268.261 |
| SoluMatrix™ (Abiraterone Acetate) | 111.316 |
Testosterone Levels
Blood Sample tested for Serum Testosterone Levels (NCT02737332)
Timeframe: Average of Day 9 and 10
| Intervention | ng/dL (Mean) |
|---|
| Zytiga® (Abiraterone Acetate) | 1.02 |
| SoluMatrix™ (Abiraterone Acetate) | 1.05 |
Percent of Subjects With PSA-50 Response
"Proportion of patients with complete suppression of PSA-50 were reported by treatment and compared for between-group differences.~These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint." (NCT02737332)
Timeframe: Day 28, Day 56, and Day 84
| Intervention | percentage of Participants (Number) |
|---|
| Day 28 | Day 56 | Day 84 |
|---|
| SoluMatrix™ (Abiraterone Acetate) | 66.7 | 63.6 | 68.4 |
,| Zytiga® (Abiraterone Acetate) | 70.4 | 65.4 | 72.0 |
PSA Levels
"All patients randomized to one of the two treatment groups, round about level of PSA.~These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint" (NCT02737332)
Timeframe: Day 28, Day 56, and Day 84
| Intervention | ng/mL (Least Squares Mean) |
|---|
| Day 28 | Day 56 | Day 84 |
|---|
| SoluMatrix™ (Abiraterone Acetate) | 22.37 | 25.29 | 26.46 |
,| Zytiga® (Abiraterone Acetate) | 37.5 | 40.84 | 33.88 |
Serum Testosterone Levels
These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint. (NCT02737332)
Timeframe: Day 28, Day 56, and Day 84
| Intervention | ng/dL (Mean) |
|---|
| Day 28 | Day 56 | Day 84 |
|---|
| SoluMatrix™ (Abiraterone Acetate) | 1.01 | 2.56 | 1 |
,| Zytiga® (Abiraterone Acetate) | 1.01 | 1.01 | 1 |
Steady State Trough Concentration of Arbiraterone
These were assessed only at the said Outcome Measure Time Frame. No additional time points to the said endpoint. (NCT02737332)
Timeframe: Day 09, Day 28, Day 56, and Day 84
| Intervention | ng/dL (Least Squares Mean) |
|---|
| Day 09 | Day 28 | Day 56 | Day 84 |
|---|
| SoluMatrix™ (Abiraterone Acetate) | 27.259 | 18.662 | 18.707 | 13.819 |
,| Zytiga® (Abiraterone Acetate) | 20.938 | 56.721 | 29.978 | 18.263 |
AUC (0-inf)
Steady state systemic exposure parameters (NCT02737332)
Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose
| Intervention | ng*hr/mL (Least Squares Mean) |
|---|
| Zytiga® (Abiraterone Acetate) | 1020.218 |
| SoluMatrix™ (Abiraterone Acetate) | 326.458 |
AUC (0-t)
Blood samples for pre-dose PK profiling were to be collected approximately 45 minutes before dosing, i.e., within 60 to 30 minutes prior to dosing. Post-dose blood samples were to be collected throughout the day at the times (15 mins, 30 mins, 1 hr, 1.5 hr, 2.0 hr 3 hr, 4 hr, 6 hr, 8 hr, 9 hr, 24 hr). (NCT02737332)
Timeframe: 60 to 30 minutes prior to dosing and over 24 Hours post-dose
| Intervention | ng*hr/mL (Least Squares Mean) |
|---|
| Zytiga® (Abiraterone Acetate) | 870.859 |
| SoluMatrix™ (Abiraterone Acetate) | 626.066 |
Pathologic Complete Response Rate as Assessed From Prostatectomy Specimens Following Neoadjuvant Treatment
Pathologic complete response is defined as no evidence of cancer on fully submitted prostatectomy specimens using standard surgical pathology assessments (i.e. H&E assessment will be used for the purpose of defining pathologic complete response per protocol) at 3 months. (NCT02849990)
Timeframe: At 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Chemotherapy) | 1 |
Overall Survival (OS)
Will will report the number of participants alive at 2-years following enrollment. (NCT02849990)
Timeframe: At 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Chemotherapy) | 20 |
Number of Patients With Pathologic T3 Disease After 3 Months of Treatment.
The presence of T3 disease (e.g. extraprostatic tumor not invading adjacent structures) will be determine from the prostatectomy specimen after 3 months of treament. (NCT02849990)
Timeframe: At 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Chemotherapy) | 18 |
Number of Patients With a Near Pathologic Complete Response After 3 Months of Treatment
The near pathologic complete response will be defined as =< 5 mm of residual tumor as assessed on prostatectomy specimens after 3 months of treatment. (NCT02849990)
Timeframe: At 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Chemotherapy) | 6 |
Number of Participants Without Biochemical Failure at 2 Years
Prostate-specific antigen progression (i.e. biochemical failure) will be defined per the American Urological Association guidelines (i.e. confirmed prostate-specific antigen post-radical prostatectomy >= 0.2 ng/mL). We will report the number of patients without biochemical failure at 2 years. (NCT02849990)
Timeframe: At 2 years
| Intervention | participants (Number) |
|---|
| Treatment (Neoadjuvant Chemotherapy) | 18 |
The Proportion of Men Who Receive Adjuvant Radiation Therapy
Patients that received radiation following prostatetomy (NCT02849990)
Timeframe: Up to 1 year post prostatectomy
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Neoadjuvant Chemotherapy) | 7 |
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 12-months Post-RP (Part 2)
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 12-months post-RP
| Intervention | score on 0-100 scale (Mean) |
|---|
| Urinary Irritative | Urinary Incontinence | Bowel | Sexual | Hormonal |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 91 | 75 | 95 | 16 | 68 |
,| Arm 2B: Observation (Part 2) | 91 | 74 | 94 | 26 | 86 |
Biochemical Progression Free Survival (bPFS) Rate at 2 Years Post RP [Part 2]
2-year bPFS rate is defined as the probability of biochemical progression free and survival at 2 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 2-year mark are censored at date of last disease evaluation. (NCT02903368)
Timeframe: At 2 years post RP
| Intervention | percentage of subjects (Number) |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 90 |
| Arm 2B: Observation (Part 2) | 80 |
Biochemical Progression Free Survival (bPFS) Rate at 3 Years Post RP [Part 2]
3-year bPFS rate is defined as the probability of biochemical progression free and survival at 3 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 3-year mark are censored at date last disease evaluation. (NCT02903368)
Timeframe: At 3 years post RP
| Intervention | percentage of subjects (Number) |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 81 |
| Arm 2B: Observation (Part 2) | 72 |
Biochemical Progression Free Survival (bPFS) Rate at 4 Years Post RP [Part 2]
4-year bPFS rate is defined as the probability of biochemical progression free and survival at 4 years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event is considered to be biochemical progression (defined as a confirmed PSA ≥ 0.2 ng/mL), local, regional, or distant metastatic disease on CT/MRI or bone scan, or receipt of post-operative systemic therapy or radiotherapy for rising PSA, or death from any cause. Participants who are lost to follow-up before the 4-year mark are censored at date of last disease evaluation. (NCT02903368)
Timeframe: At 4 years post RP
| Intervention | percentage of subjects (Number) |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 67 |
| Arm 2B: Observation (Part 2) | 61 |
Rate of Freedom From Further Anti-cancer Therapy at 4-years Post RP (Part 2)
Defined as the probability of freedom from further anti-cancer therapy at 4-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 4-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 4-years post RP
| Intervention | percentage of subjects (Number) |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 78 |
| Arm 2B: Observation (Part 2) | 67 |
Frequency of Positive Surgical Margins at RP (Part 1)
Pathologic specimens were centrally reviewed and counted for positive surgical margins at the time of Radical Prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 4 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 7 |
Frequency of Presenting Intra-operative Complications Following RP (Part 1)
Intra-operative complications were collected via questionnaire following Radical Prostatectomy. (NCT02903368)
Timeframe: Assessed post-RP, at 6 months from the initiation of neoadjuvant therapy.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 1 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 1 |
Frequency of Presenting Intraductal Carcinoma at RP (Part 1)
Intraductal carcinoma was evaluated by central pathology review of specimens at Radical Prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 15 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 19 |
Combined pCR or MRD Rate [Part 1]
Pathological response, defined as achieving either pCR or MRD at radical prostatectomy (RP). Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as residual tumor in the RP specimen measuring ≤ 5 mm. (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 12 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 12 |
Rate of Freedom From Further Anti-cancer Therapy at 3-years Post RP (Part 2)
Defined as the probability of freedom from further anti-cancer therapy at 3-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 3-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 3 years post RP
| Intervention | percentage of subjects (Number) |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 83 |
| Arm 2B: Observation (Part 2) | 72 |
Rate of Freedom From Further Anti-cancer Therapy at 2-years Post RP (Part 2)
Defined as the probability of freedom from further anti-cancer therapy at 2-years from the date of Part 2 randomization, which is estimated using Kaplan Meier methods. The event includes initiation of anti-cancer therapy (radiation therapy, ADT, or other therapies) for rising PSAs and/or clinical progression. Participants who are lost to follow-up before the 2-year mark are censored at date of last follow-up. (NCT02903368)
Timeframe: At 2-years post RP
| Intervention | percentage of subjects (Number) |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 90 |
| Arm 2B: Observation (Part 2) | 80 |
Percent of Participants With Nadir PSA < 0.2 ng/mL Prior to RP (Part 1)
Prostate specific antigen (PSA) was measured on day 1 of each cycle during the neoadjuvant therapy. PSA nadir was defined as the lowest PSA value prior to Radical Prostatectomy (RP). Number and percent of participants with nadir PSA < 0.2 ng/mL were reported. (NCT02903368)
Timeframe: Assessed on day 1 of each cycle (1 cycle=28 +/- 2 days), up to 6 months from the initiation of neoadjuvant therapy.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 55 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 58 |
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 6-months Post-RP (Part 2)
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 6-months post-RP
| Intervention | Score on 0-100 (Mean) |
|---|
| Urinary Irritative | Urinary Incontinence | Bowel | Sexual | Hormonal |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 90 | 63 | 95 | 17 | 68 |
,| Arm 2B: Observation (Part 2) | 92 | 72 | 96 | 14 | 83 |
Rate of pCR at RP (Part 1)
Pathological Complete Response (pCR) is defined as the absence of morphologically identifiable carcinoma in the RP specimen at radical prostatectomy (RP). (NCT02903368)
Timeframe: Assessed from RP specimens, at 6 months from the initiation of neoadjuvant therapy.
| Intervention | Participants (Count of Participants) |
|---|
| Arm 1A: AAPL Neoadjuvant Therapy (Part 1) | 7 |
| Arm 1B: APL Neoadjuvant Therapy (Part 1) | 6 |
Mean Scores for Quality of Life (QOL) Questionnaires EPIC-26 at 24-months Post-RP (Part 2)
The QOL will be measured using the Expanded Prostate Cancer Index Composite 26 (EPIC-26). For part 2, the questionnaires will be administered at 6 months, 12 months, and 24 months post RP. Resulting domain scores for EPIC-26 (urinary incontinence, urinary obstruction, sexual, bowel, hormonal/vitality) is on a 0-100 scale, with higher values representing a more favorable health-related QOL. (NCT02903368)
Timeframe: At 24-months post-RP
| Intervention | score on 0-100 scale (Mean) |
|---|
| Urinary Irritative | Urinary Incontinence | Bowel | Sexual | Hormonal |
|---|
| Arm 2A: AAPL Adjuvant Therapy (Part 2) | 92 | 75 | 95 | 31 | 88 |
,| Arm 2B: Observation (Part 2) | 93 | 76 | 97 | 26 | 90 |
Testosterone Levels
Change in serum testosterone levels from baseline (NCT02962284)
Timeframe: Baseline and 360 days
| Intervention | ng/dL (Mean) |
|---|
| Preceding Treatment - Yonsa | -6.24 |
| Preceding Treatment - Zytiga | -5.87 |
Testosterone Complete Suppression
Proportion of subjects with complete suppression of testosterone levels (NCT02962284)
Timeframe: 360 days
| Intervention | percentage of subjects (Number) |
|---|
| Preceding Treatment - Yonsa | 100 |
| Preceding Treatment - Zytiga | 87.5 |
Prostate Specific Antigen Levels
Change in serum testosterone levels after one year of treatment against baseline (NCT02962284)
Timeframe: One year
| Intervention | ng/dL (Mean) |
|---|
| Preceding Treatment - Yonsa | -60.12 |
| Preceding Treatment - Zytiga | -112.76 |
Proportion of Subjects With Disease Progression
Number of participants who had disease progression (NCT02962284)
Timeframe: one year
| Intervention | Participants (Count of Participants) |
|---|
| Preceding Treatment - Yonsa | 1 |
| Preceding Treatment - Zytiga | 3 |
Number of Subjects With Adverse Events
Adverse events (NCT02962284)
Timeframe: one year
| Intervention | Participants (Number) |
|---|
| Preceding Treatment - Yonsa | 8 |
| Preceding Treatment - Zytiga | 9 |
Percentage of Subjects With Prostate Specific Antigen - 50 Response
A decrease of ≥50% reduction from baseline of the study CHL-AA-201 (NCT02962284)
Timeframe: 360 days
| Intervention | percentage of number of subjects (Number) |
|---|
| Preceding Treatment - Yonsa | 60.0 |
| Preceding Treatment - Zytiga | 55.6 |
PSA Response in Participants With a BRCA or ATM Alteration Combined
Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory. (NCT02975934)
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)
| Intervention | percentage of participants (Number) |
|---|
| Rucaparib | 41.9 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 26.7 |
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
"The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first).~Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan)." (NCT02975934)
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 11.2 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 6.4 |
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
"The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first).~Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan)." (NCT02975934)
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 10.2 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 6.4 |
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later. (NCT02975934)
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 6.6 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 3.8 |
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later. (NCT02975934)
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 5.7 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 3.6 |
Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling
Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented. (NCT02975934)
Timeframe: From enrollment to week 5 of dosing
| Intervention | ng/mL (Median) |
|---|
| Rucaparib | 1310 |
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. (NCT02975934)
Timeframe: From enrollment to up to approximately 25 weeks
| Intervention | units on a scale (Mean) |
|---|
| BPI-SF Pain Score | BPI-SF Interference Score |
|---|
| Abiraterone Acetate or Enzalutamide or Docetaxel | 0.14 | 0.65 |
,| Rucaparib | -0.32 | -0.28 |
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria. (NCT02975934)
Timeframe: From enrollment to 6 months
| Intervention | percentage of participants (Number) |
|---|
| Rucaparib | 63.0 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 22.7 |
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. (NCT02975934)
Timeframe: From enrollment to up to approximately 25 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Rucaparib | 2.4 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 1.8 |
Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
"ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment).~CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters." (NCT02975934)
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
| Intervention | Participants (Count of Participants) |
|---|
| Rucaparib | 37 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 9 |
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
"ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment).~CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters." (NCT02975934)
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
| Intervention | Participants (Count of Participants) |
|---|
| Rucaparib | 37 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 7 |
Interim Overall Survival in Participants With a BRCA or ATM Alteration Combined
Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive. (NCT02975934)
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 23.6 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 20.9 |
Interim Overall Survival in Participants With a BRCA Alteration
Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive. (NCT02975934)
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 24.3 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 20.8 |
Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented. (NCT02975934)
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 7.4 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 7.4 |
Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented. (NCT02975934)
Timeframe: From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
| Intervention | months (Median) |
|---|
| Rucaparib | 7.4 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 7.4 |
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
Defined as the percentage of participants with a Complete Response (CR), Partial Response (PR), and Stable Disease (SD), according to Modified RECIST Version 1.1 with no progression in bone per PCWG3 Criteria. (NCT02975934)
Timeframe: From enrollment to 6 months
| Intervention | percentage of participants (Number) |
|---|
| Rucaparib | 57.6 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 25.4 |
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase. (NCT02975934)
Timeframe: From enrollment to up to approximately 25 weeks
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Rucaparib | -0.8 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | -3.9 |
PSA Response in Participants With a BRCA Alteration
Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory. (NCT02975934)
Timeframe: From enrollment to primary completion of study (up to approximately 5 years)
| Intervention | percentage of participants (Number) |
|---|
| Rucaparib | 54.7 |
| Abiraterone Acetate or Enzalutamide or Docetaxel | 26.7 |
Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only
The time from randomisation until the date of objective radiological disease progression (determined by RECIST 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG-3) (bone)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Progression is defined using (i) Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue, as a >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters; (ii) Prostate Cancer Working Group 3 (PGWG-3) for bone as >= 2 new bone lesions on the 1st week 8 scan compared to baseline. The confirmatory scan, >=6 weeks later, must show >=2 more new bone lesions (for a total of >=4 new bone lesions since baseline). (NCT02987543)
Timeframe: Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
| Intervention | Months (Median) |
|---|
| Cohort A Olaparib 300mg bd | 7.39 |
| Cohort A Investigators Choice of NHA | 3.55 |
Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B
The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. (NCT02987543)
Timeframe: Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
| Intervention | Months (Median) |
|---|
| Cohort A Olaparib 300mg bd | 5.82 |
| Cohort A Investigators Choice of NHA | 3.52 |
Time to Pain Progression - Cohort A Only
Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain [Item 3] and Analgesic Quantification Algorithm [AQA] score. (NCT02987543)
Timeframe: Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
| Intervention | Months (Median) |
|---|
| Cohort A Olaparib 300mg bd | NA |
| Cohort A Investigators Choice of NHA | 9.92 |
Time to Prostate-specific Antigen Recurrence
To investigate the time from an undetectable Prostate-specific antigen (≤0.2 ng/mL) until the Prostate-specific antigen is >0.2 over two time-points. (NCT03043807)
Timeframe: 3 years
| Intervention | Month (Median) |
|---|
| Chemohormonal and Definitive Therapy After Prostatectomy | NA |
Number of Participants With Incidence of Adverse Events
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Incidence of serious adverse events and 95% confidence interval will be provided overall as well as for each major affected organ category. (NCT03279250)
Timeframe: From screening up to 4 weeks post-surgery, an average of 7 months
| Intervention | Participants (Count of Participants) |
|---|
| Serious | Non Serious |
|---|
| Arm A (LHRHa, Apalutamide) | 1 | 34 |
,| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 2 | 34 |
The Number of Participants With Rate of Pathologic Stage =< pT2N0 at Prostatectomy
The study will provide a point estimate and 95% confidence interval of the proportion of patients with pathologic stage =< pT2N0 at prostatectomy for each arm. Patient characteristics will be summarized using descriptive statistics for each arm. (NCT03279250)
Timeframe: At the time of radical prostatectomy
| Intervention | Participants (Count of Participants) |
|---|
| Arm A (LHRHa, Apalutamide) | 13 |
| Arm B (LHRHa, Apalutamide, Abiraterone Acetate) | 12 |
Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death). (NCT03431350)
Timeframe: Up to 37 months
| Intervention | Participants (Count of Participants) |
|---|
| Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | 14 |
| Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | 8 |
Combination 1: Part 1: Number of Participants With Specified Toxicity
Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) >=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G<=2 in <7 days, vomiting and diarrhea resolved in <=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G<=2 in <=7 days, elevation in AST/ALT for <=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia >=7 days or G3 or 4 neutropenia with infection/fever >38.5 degrees Celsius; Any TR SAE or intolerable toxicity. (NCT03431350)
Timeframe: Cycle 1 (28 days)
| Intervention | Participants (Count of Participants) |
|---|
| Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | 0 |
| Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | 0 |
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose
AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
| Intervention | nanogram*hour/milliliter/milligram (Mean) |
|---|
| Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 73.36 |
| Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 59.31 |
| Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 66.61 |
Combination 1: Part 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. (NCT03431350)
Timeframe: Up to 37 months
| Intervention | Participants (Count of Participants) |
|---|
| Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | 21 |
| Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | 11 |
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose
Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
| Intervention | nanograms per milliliter per milligram (Mean) |
|---|
| Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 2.14 |
| Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 1.99 |
| Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 2.09 |
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose
Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
| Intervention | Nanograms per milliliter (ng/mL) (Mean) |
|---|
| Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 428 |
| Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 398 |
| Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 417 |
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose
AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose. (NCT03431350)
Timeframe: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
| Intervention | Nanograms*hour per milliliter (ng*h/mL) (Mean) |
|---|
| Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 14672 |
| Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 11862 |
| Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 13321 |
Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death). (NCT03431350)
Timeframe: Up to 31 months
| Intervention | Participants (Count of Participants) |
|---|
| Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | 6 |
| Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | 7 |
| Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | 4 |
| Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | 1 |
Combination 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. (NCT03431350)
Timeframe: Up to 31 months
| Intervention | Participants (Count of Participants) |
|---|
| Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | 8 |
| Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | 9 |
| Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | 5 |
| Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | 1 |
Combination 2: Composite Response Rate (RR)
Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (>=) 1 at baseline or CTC less than (<) 5 per 7.5 mL with CTC >=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of >=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol. (NCT03431350)
Timeframe: Up to 31 months
| Intervention | Percentage of participants (Number) |
|---|
| Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | 75.0 |
| Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | 55.6 |
| Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | 33.3 |
Combination 1: Part 2: Objective Response Rate (ORR)
ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria. (NCT03431350)
Timeframe: Up to 37 months
| Intervention | Percentage of participants (Number) |
|---|
| Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | 23.8 |
| Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | 9.1 |
Incidence of Adverse Events
Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Safety and tolerability as evaluated by the incidence, severity, duration, causality, seriousness of adverse events. Toxicities will be summarized as the number of patients with grade 3 or higher toxicities per CTCAE v4.0, in addition to total number of toxicities (allowing for multiple toxicities within a patient) among all patients, and per treatment arm. (NCT03649841)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (ADT, Abiraterone, Prednisone) | 2 |
| Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) | 0 |
Rate of Undetectable Prostate Specific Antigen (PSA) (< 0.2)
The number of patients with undetectable PSA at 6-months will be summarized by each arm and all combined. (NCT03649841)
Timeframe: At 6 months after start of abiraterone acetate
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (ADT, Abiraterone, Prednisone) | 1 |
| Arm II (ADT, Abiraterone, Prednisone, Radiation Therapy) | 1 |
Functional Assessment of Cancer Therapy- Prostate Cancer (FACT-P)
"Functional Assessment of Cancer Therapy-Prostate Cancer (FACT-P) total score and Functional Assessment of Cancer Therapy-General (FACT-G) total score.~Total FACT-P score is the sum of Physical Well-being (PWB), Social Well-being (SWB), Emotional Well-being (EWB), Functional Well-being (FWB) and Prostate cancer subscale (PCS). FACT-P total score change from baseline values can be a minimum of -156 and a maximum of 156. A positive value indicates improvement.~FACT-G total score is the sum of PWB, SWB, EWB and FWB. FACT-G Total score change from baseline values can be a minimum of -108 and a maximum of 108. A positive value indicates improvement." (NCT03732820)
Timeframe: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
| Intervention | Score (Least Squares Mean) |
|---|
| Change from baseline in FACT-P Total | Change from baseline in FACT-G Total |
|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | -5.84 | -5.06 |
,| Placebo bd + Abiraterone 1000 mg qd | -5.30 | -4.35 |
Number of Participants With Radiological Progression Free Survival (rPFS) Event by Investigator Assessment
"An rPFS event is defined as progression determined by Response Evaluation Criteria in Solid Tumours version 1.1 [RECIST 1.1] and/or Prostate Cancer Working Group 3 [PCWG-3] or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy prior to progression.~Per RECIST v1.1, progression is defined as the sum of TLs has a 20% and absolute ≥ 5mm increase from nadir, and/or unequivocal progression in any non target lesions, and/or any new lesion identified.~Per PCWG3, progression on a bone scan is defined as 2 or more new lesions observed from the first visit after baseline compared to baseline, or from all other visits compared to first visit after baseline. A confirmatory scan is required." (NCT03732820)
Timeframe: Assessed from date of randomisation to data cut off (DCO1): 30Jul2021 (Approx. 2 years 9 months)
| Intervention | Participants (Count of Participants) |
|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 168 |
| Placebo bd + Abiraterone 1000 mg qd | 226 |
Number of Participants With Second Progression or Death (PFS2) Event
An event for PFS2 is defined as the second progression on next-line anticancer therapy or death, whichever occurs earlier. (NCT03732820)
Timeframe: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
| Intervention | Participants (Count of Participants) |
|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 103 |
| Placebo bd + Abiraterone 1000 mg qd | 126 |
Number of Participants With Time to First Subsequent Anticancer Therapy or Death (TFST) Event
A TFST (excluding radiotherapy) event is defined as the start of the first subsequent anticancer therapy after discontinuation of randomised treatment or death from any cause. (NCT03732820)
Timeframe: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
| Intervention | Participants (Count of Participants) |
|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 255 |
| Placebo bd + Abiraterone 1000 mg qd | 285 |
Number of Participants With Time to Pain Progression (TTPP) Event
A TTPP event is defined as pain progression based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 (range 0-10, a higher score indicates worse pain) and opiate analgesic use (Analgesic quantification algorithm [AQA] score, range 0-7, a higher score indicates increased opioid use). For patients who are asymptomatic at baseline (average worst pain score of 0 and not taking opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits or initiation of opioid use; For patients who are symptomatic at baseline (average worst pain score >0 and/or receiving opioids): A ≥2 point change from baseline in average (4-7 days) worst pain score observed at 2 consecutive visits and an average worst pain score ≥4, and no decrease in average opioid use (≥1-point decrease in AQA score from a starting value of ≥2), or increase in opioid use (≥1-point increase, or ≥2-point increase if the starting value is 0) at 2 consecutive follow-up visits. (NCT03732820)
Timeframe: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
| Intervention | Participants (Count of Participants) |
|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 68 |
| Placebo bd + Abiraterone 1000 mg qd | 60 |
Number of Participants With Opiate Use
An event for opiate use is defined as the first opiate use for cancer related pain. (NCT03732820)
Timeframe: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months)
| Intervention | Participants (Count of Participants) |
|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 58 |
| Placebo bd + Abiraterone 1000 mg qd | 45 |
Number of Participants With Overall Survival (OS) Event
An OS event is defined as death by any cause, regardless of whether the patient withdraws from randomised therapy or receives another anticancer therapy. (NCT03732820)
Timeframe: Assessed from date of randomisation to data cut off (DCO3): 12Oct2022 (Approx. 3 years 11 months). DCO3 is the final data cut-off for the OS analysis and therefore no further updates will be made.
| Intervention | Participants (Count of Participants) |
|---|
| Olaparib 300 mg bd + Abiraterone 1000 mg qd | 176 |
| Placebo bd + Abiraterone 1000 mg qd | 205 |
Cohort 1: Radiographic Progression-Free Survival (rPFS) as Assessed by Blinded Independent Central Review (BICR)
As per BICR, rPFS is time interval from the date of randomization to radiographic progression or death, whichever occurs first. Radiographic progression was determined by: 1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) as per response evaluation criteria in solid tumors (RECIST) 1.1; 2) Progression of bone lesions observed by bone scan based on prostate cancer working group 3 (PCWG3) criteria. PCWG3 criteria: bone progression was confirmed by subsequent scan greater than or equal to (>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. Confirmatory scan >=2 new lesions indicate progression; scan does not show >= 2 new lesions means no progression. If Week 8 scan less than (<) 2 new bone lesions compared to baseline, the initial scan >=2 new lesions compared to Week 8 scan indicates progression if confirmed by subsequent scan >=6 weeks later. (NCT03748641)
Timeframe: Up to 32 months
| Intervention | Months (Median) |
|---|
| Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 16.46 |
| Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg | 13.70 |
Change in Quality of Life - FACT/GOG-NTX
Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX) (FACT/GOG-NTX) scale (version 4). FACT/GOG-NTX total score ranges from 0 to 152, with higher scores indicating a higher quality of life. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months
| Intervention | score on a scale (Number) |
|---|
| Baseline Score | Month 3 Score |
|---|
| Arm A (ADT, Docetaxel) | 131.83 | 126 |
Change in Quality of Life - PROMIS Fatigue
Quality of Life questionnaires will be done every 3 months while participants are on treatment. The scale used will be the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale. Total raw scores range from 7 to 35, with higher scores indicating a higher level of fatigue. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months
| Intervention | score on a scale (Number) |
|---|
| Baseline Score | Month 3 Score |
|---|
| Arm A (ADT, Docetaxel) | 10 | 16 |
Prostate Specific Antigen Progression Free Survival (PSA-PFS)
Prostate Specific Antigen (PSA) will be measured every three months while on study. PSA Progression Free Survival (PSA-PSF) will be reported as the number of participants who have not demonstrated PSA progression by the end of the follow-up period. PSA progression is defined by meeting the following criteria: 1) an increase in PSA of greater than or equal to 25% from baseline or nadir, AND 2) an increase in PSA of at least 2 ng/dL, AND 3) the increase is confirmed at least 3 weeks later. This analysis was planned for up to 18 months following study enrollment, but the only participant enrolled on the study was only followed for 3 months. (NCT03827473)
Timeframe: Planned up to 18 months, but actual was 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm A (ADT, Docetaxel) | 1 |
Prostate-specific Antigen (PSA) Response
PSA evaluations will occur every 3 months while on study. PSA response is defined as a reduction in PSA value of greater than or equal to 90% from baseline, reported as a count of participants who had a PSA response on the study. (NCT03827473)
Timeframe: Planned for up to 18 months, but actual was 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm A (ADT, Docetaxel) | 1 |
Change in Quality of Life - FACT-P
The impact of abiraterone acetate and docetaxel on health related quality of life will be assessed every 3 months from screening to month 12 of treatment or follow-up. The scale used will be the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scale. The total score ranges from 0 to 156, with higher scores indicating a higher quality of life. The primary endpoint was intended to be quality of life at 12 months, but since no participants completed 12 months of treatment/follow-up, scores at baseline and 3 months are reported instead. (NCT03827473)
Timeframe: Planned for up to one year, but actual was 3 months
| Intervention | score on a scale (Number) |
|---|
| Baseline Score | Month 3 Score |
|---|
| Arm A (ADT, Docetaxel) | 139.83 | 127 |
Overall Survival (OS)
Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves. (NCT03834519)
Timeframe: Up to ~31 months
| Intervention | Months (Median) |
|---|
| Pembrolizumab + Olaparib | 15.8 |
| Next-generation Hormonal Agent Monotherapy (NHA) | 14.6 |
Radiographic Progression-Free Survival (rPFS)
rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions or ≥2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves. (NCT03834519)
Timeframe: Up to ~31 months
| Intervention | Months (Median) |
|---|
| Pembrolizumab + Olaparib | 4.4 |
| Next-generation Hormonal Agent Monotherapy (NHA) | 4.2 |
Incidence and Severity of Adverse Events (AEs)
Will be assessed using version National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will characterize AEs by type and grade. Safety will be summarized as the severity and frequency of a given AE. (NCT03999515)
Timeframe: Within 14 days of end of treatment, an average of 1 year.
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) | 3 |
Time to Response
Time to response is the time until a radiographic response occures as determined by RECIST 1.1 criteria. This cannot be determined since only two patients had re-staging scans on study and neither had a response. (NCT03999515)
Timeframe: Up to 67 days
| Intervention | years (Number) |
|---|
| Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) | NA |
Radiographic Progression Free Survival (PFS)
Progression free survival is time to progressive disease. Disease progression is determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue metastases and Prostate Cancer Working Group 3 criteria for bone metastases. Median progression free survival will be calculated. (NCT03999515)
Timeframe: Up to 67 days
| Intervention | days (Median) |
|---|
| Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) | 59 |
Objective Response Rate
Will be calculated as the percentage of patients, with 95% confidence intervals, achieving a complete response or partial response across the entire study population at any time. (NCT03999515)
Timeframe: Up to 67 days
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) | 0 |
Prostate-specific Antigen (PSA) Response
PSA response will be defined by a > 50% reduction in PSA compared with baseline at any point during treatment. We will report the percentage of patients who achieve a PSA response. (NCT03999515)
Timeframe: Baseline up to 73 days
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) | 0 |
Overall Survival (OS)
Overall survival is time to death from any cause. Median overall survival survival will be calculated. (NCT03999515)
Timeframe: From cycle 1, day 1 to the date of death, assessed up to 178 days
| Intervention | days (Median) |
|---|
| Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) | 94 |