prednisone and Androgen-Independent Prostatic Cancer

prednisone has been researched along with Androgen-Independent Prostatic Cancer in 310 studies

Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.

Research

Studies (310)

Authors

Clinical Trials (49)

Trial Overview

Trial Outcomes

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

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

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

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

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

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

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

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

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

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

Time to Skeletal-Related Event

Time to skeletal-related event was defined as the earliest of the following: clinical or pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone. (NCT01715285)
Timeframe: Up to 66 months

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

Overall Survival, Intention-to-treat Population

Overall survival is defined as the time from randomization until death due to any cause. (NCT02111577)
Timeframe: From randomization to death due to any cause, up to 58 months

Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy

Overall survival is defined as the time from randomization until death due to any cause. (NCT02111577)
Timeframe: From randomization to death due to any cause, up to 58 months

Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy

Overall survival is defined as the time from randomization until death due to any cause. (NCT02111577)
Timeframe: From randomization to death due to any cause, up to 58 months

Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide

Overall survival is defined as the time from randomization until death due to any cause. (NCT02111577)
Timeframe: From randomization to death due to any cause, up to 58 months

Overall Survival, Per Protocol Population

Overall survival is defined as the time from randomization until death due to any cause. (NCT02111577)
Timeframe: From randomization to death due to any cause, up to 58 months

Proportion of Patients With Skeletal-related Events, Intention-to-treat Population

"Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.~Skeletal-related events included:~Radiation therapy to bone~Pathologic bone fracture~Spinal cord compression~Surgery to bone~Change in antineoplastic therapy to treat bone pain" (NCT02111577)
Timeframe: From randomization to the end of the study, up to 57 months

Proportion of Patients With Skeletal-related Events, Per Protocol Population

"Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.~Skeletal-related events included:~Radiation therapy to bone~Pathologic bone fracture~Spinal cord compression~Surgery to bone~Change in antineoplastic therapy to treat bone pain" (NCT02111577)
Timeframe: From randomization to the end of the study, up to 57 months

Radiological Progression-free Survival, Intention-to-treat Population

Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. (NCT02111577)
Timeframe: Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months

Radiological Progression-free Survival, Per Protocol Population

Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan. (NCT02111577)
Timeframe: Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months

Time to First Skeletal-related Event, Intention-to-treat Population

"Skeletal-related events included:~Radiation therapy to bone~Pathologic bone fracture~Spinal cord compression~Surgery to bone~Change in antineoplastic therapy to treat bone pain" (NCT02111577)
Timeframe: Time from randomization to the date of the first skeletal-related event, up to 58 months

Time to First Skeletal-related Event, Per Protocol Population

"Skeletal-related events included:~Radiation therapy to bone~Pathologic bone fracture~Spinal cord compression~Surgery to bone~Change in antineoplastic therapy to treat bone pain" (NCT02111577)
Timeframe: Time from randomization to the date of the first skeletal-related event, up to 58 months

Time to PSA Progression, Intention-to-treat Population

The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later. (NCT02111577)
Timeframe: Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months

Time to PSA Progression, Per Protocol Population

The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later. (NCT02111577)
Timeframe: Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase ≥ 2 ng/mL and ≥ 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months

Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population

"Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.~Skeletal-related events included:~Radiation therapy to bone~Pathologic bone fracture~Spinal cord compression~Surgery to bone~Change in antineoplastic therapy to treat bone pain" (NCT02111577)
Timeframe: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

Time to Radiological Progression or Skeletal-related Event, Per Protocol Population

"Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.~Skeletal-related events included:~Radiation therapy to bone~Pathologic bone fracture~Spinal cord compression~Surgery to bone~Change in antineoplastic therapy to treat bone pain" (NCT02111577)
Timeframe: Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months

Part A: Number of Patients With Dose Limiting Toxicities (DLTs)

"DLTs were assessed by a Safety Review Committee (SRC) after a minimum of 3 patients had received at least 14 days of treatment in Part A.~A DLT was defined as any toxicity which was not a recognised AE of abiraterone or prednisolone, and was not attributable to the disease or disease-related processes under investigation, which occurred during a minimum period of 14 days treatment and which included: 1. haematological toxicity CTCAE v4.0 Grade 4 or higher present for more than 4 days (except anaemia); 2. non-haematological toxicity CTCAE v4.0 Grade 3 or higher including infection, corrected QT interval prolongation; 3. any other toxicity that was greater than that at baseline, was clinically significant and/or unacceptable, did not respond to supportive care, resulted in a disruption of dosing schedule of 7 days or more, or was judged to be a DLT by the SRC.~A DLT excluded alopecia and isolated laboratory changes of any grade without clinical sequelae or clinical significance." (NCT01972217)
Timeframe: From Day 1 for Cohort 1 and from Day 4 for Cohort 2 up to 14 days treatment with olaparib + abiraterone for 3 patients.

Part B: Median Best Percentage Change From Baseline in Circulating Tumour Cell (CTC) Level

"The median best percentage change from baseline in CTC levels was determined to assess the anti-tumour activity of olaparib when given in combination with abiraterone, compared with placebo given in addition to abiraterone.~The best percentage change was defined as the biggest CTC level reduction compared with baseline or smallest increase in the absence of a decrease." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 24, and then every 12 weeks.

Part B: Median Best Percentage Change From Baseline in Prostate Specific Antigen (PSA) Levels

"The best percentage change from baseline in PSA levels was determined to assess the anti-tumour activity of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~The best percentage change was defined as the biggest reduction in PSA level compared with baseline or smallest increase in the absence of a decrease." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 52, and then every 12 weeks.

Part B: Median Overall Survival (OS)

"OS was determined to assess the efficacy of olaparib when given in addition to abiraterone, compared with placebo given in addition to abiraterone.~OS was performed at the time of the analysis of rPFS, and the median OS, calculated using the Kaplan-Meier technique, is presented." (NCT01972217)
Timeframe: From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.

Part B: Median Radiological Progression-Free Survival (rPFS) Time

"The efficacy of olaparib when given in combination with abiraterone was assessed by rPFS, defined as the time from randomisation to disease progression using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (for soft tissue disease) and Prostate Cancer Working Group 2 (PCWG-2) (for bone disease) criteria, or death.~Progression using RECIST 1.1 criteria was defined as at least 20% increase from baseline in the sum of diameters of target lesions, progression of existing non-target lesions, or the appearance of at least 1 new lesion.~Progression using PCWG-2 criteria was determined if 2 or more new metastatic bone lesions were observed (with a total of at least 4 new lesions since baseline assessment if observed at the 12 week scan, or persistence of or increase in number of lesions if observed after the 12 week scan as determined by a confirmatory scan at least 6 weeks later or at next scheduled visit)." (NCT01972217)
Timeframe: From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.

Part B: Median Time to Second Progression or Death (PFS2)

The efficacy of olaparib when given in combination with abiraterone was assessed by PFS2, defined by local standard clinical practice and included objective radiological progression by RECIST 1.1 (soft tissue), symptomatic progression, rise in PSA level or death in the absence of overall progression. (NCT01972217)
Timeframe: From randomisation until analysis cut-off date (up to approximately 3 years).

Part B: Percentage of Patients With at Least One Objective Response (Objective Response Rate [ORR])

"The overall radiological ORR was calculated to assess the anti-tumour activity of olaparib in combination with abiraterone, compared with placebo in combination with abiraterone.~The best overall ORR was defined as the percentage of patients with at least 1 visit response of complete response (CR) or partial response (PR) in soft tissue disease assessed by RECIST 1.1 and also bone scan status of non-progressive disease or non-evaluable for their bone scans assessed by PCWG-2.~CR: Disappearance of all target lesions. Reduction of pathological lymph nodes to <10 millimetres.~PR: At least a 30% decrease in the sum of diameters of target lesions from baseline.~The percentage of patients with a response is presented." (NCT01972217)
Timeframe: From baseline, then every 4 weeks up to Week 52, and then every 12 weeks.

Part B: Percentage of Patients With Progression Events or Death (rPFS)

"The efficacy of olaparib when given in combination with abiraterone was assessed by rPFS, defined as the time from randomisation to disease progression using RECIST version 1.1 (for soft tissue disease) and PCWG-2 (for bone disease) criteria, or death.~Progression using RECIST 1.1 criteria was defined as at least 20% increase from baseline in the sum of diameters of target lesions, progression of existing non-target lesions, or the appearance of at least 1 new lesion.~Progression using PCWG-2 criteria was determined if 2 or more new metastatic bone lesions were observed (with a total of at least 4 new lesions since baseline assessment if observed at the 12 week scan, or persistence of or increase in number of lesions if observed after the 12 week scan as determined by a confirmatory scan at least 6 weeks later or at next scheduled visit).~The percentage of patients with progression events is presented overall and according to RECIST 1.1 and/or PCWG-2 criteria, or death." (NCT01972217)
Timeframe: From baseline, every 12 weeks up to Week 72, then every 24 weeks up to 24 months.

Median Time to First Subsequent Therapy (TFST) and Median Time to Second Subsequent Therapy (TSST)

"The TFST and TSST were determined to assess the anti-tumour activity of olaparib when given in combination with abiraterone, compared with placebo given in addition to abiraterone.~TFST was defined as the time from randomisation to the earlier of first subsequent anti-cancer therapy start date following study treatment discontinuation, or death.~TSST was defined as the time from randomisation to the earlier of the second subsequent anti-cancer therapy start date following study treatment discontinuation, or death." (NCT01972217)
Timeframe: From randomisation until analysis cut-off date (up to approximately 3 years).

Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Part A Pharmacokinetics (PK): Olaparib Maximum Plasma Concentration at Steady State (Cmax,ss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib Cmax,ss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib AUCss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.

Part A PK Analysis: Olaparib Area Under the Plasma Concentration-Time Curve at Steady State (AUCss)

"Following multiple dosing to steady state of olaparib 300 mg bid, the Cohort 2 olaparib AUCss is presented for olaparib monotherapy and for olaparib given in combination with abiraterone.~Only patients with data available for analysis at each time point are presented." (NCT01972217)
Timeframe: PK sampling for Cohort 2 Group 1 was between Days 3 and 7 for olaparib, and Days 4 and 8 for olaparib and abiraterone. PK sampling for Cohort 2 Group 2 was between Days 5 and 7 for abiraterone, and Days 6 and 8 for olaparib and abiraterone.