prednisone and Adenocarcinoma

prednisone has been researched along with Adenocarcinoma in 177 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.

Adenocarcinoma: A malignant epithelial tumor with a glandular organization.

Research

Studies (177)

Authors

Clinical Trials (34)

Trial Overview

Trial Outcomes

Median Prostate Specific Antigen (PSA) Nadir

PSA nadir is the lowest PSA level recorded during neoadjuvant therapy. (NCT02268175)
Timeframe: PSA was assessed at baseline and every cycle during neoadjuvant therapy (up to 24 weeks).

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

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

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

Overall Survival Time

"Overall survival (OS) time was measured as the time from date of randomization to the date of death due to any cause.~The median OS time and its 95.6% confidence interval were estimated using the Kaplan-Meier method. In the absence of confirmation of death, the participant was censored at the last date he/she was known to be alive or the study cut-off date (when 873 deaths have occurred), whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Pain Progression-free Survival Time

"Pain progression was defined as either ≥1-point increase in Present Pain Intensity (PPI) score or ≥25% increase in Analgesics Score (AS) confirmed at least 3 weeks later, or requirement for palliative radiotherapy. PPI scale is a self-report 0-5 scale to assess pain intensity - a score 0 reflects no pain, a score 5 reflects excruciating pain. AS is a scoring method to assess analgesics consumption. Each analgesic is scored 1 or 4 depending on the analgesic type and dose. AS is the sum of the analgesic scores.~Pain progression-free survival (PFS) time was measured as the time from the date of randomization up to the date of first pain progression or death due to any cause, whichever occurred first.~The median pain-PFS and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of event, the participant was censored at the the date of last assessment without evidence of pain progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Pain Response Rate

Pain response was defined as either a ≥2-point decrease from baseline in Present Pain Intensity (PPI) score without increase in Analgesics Score (AS), or a ≥50% decrease from baseline in AS without increase in the PPI score confirmed at least 3 weeks later. Increases in PPI or AS during the first 12 weeks were ignored in determining pain response. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 weeks up to pain progression or the cut-off date, whichever occurred first

Progression Free Survival Time

"Disease progression was defined as a composite of: Radiological tumor progression (≥20% increase in target lesions, or appearance of at least 2 new bone lesions); PSA progression (≥25% increase in PSA level confirmed 3 weeks later); Pain progression (increase in pain intensity or in analgesic consumption for cancer related pain confirmed 3 weeks later); Radiotherapy for cancer related symptoms; Occurence of Skeletal related events (SRE).~Progression Free survival (PFS) time was measured as the time from the date of randomization up to the date of occurrence of the first event defining a disease progression or death due to any cause, whichever occurred first.~The median PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of disease progression, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Prostate Specific Antigen Progression-free Survival Time

"Prostate specific antigen (PSA) progression was defined as ≥25% increase in PSA level confirmed 3 weeks later, above the nadir in participants who had achieved a PSA response, or above the baseline in participants who hadn't achieved a PSA response.~PSA progression-free survival (PFS) time was defined as the time from the date of randomization up to the date of the first documented PSA progression or death due to any cause, whichever occurred first.~The median PSA-PFS time and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of PSA progression or death, the participant was censored at the the date of last assessment without evidence of progression or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Prostate Specific Antigen Response Rate

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. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 weeks up to PSA progression (≥25% increase) or the cut-off date, whichever occurred first

Time to Skeletal Related Events

"Skeletal Related Events (SRE) included pathological fractures and/or spinal cord compression, need for bone irradiation, including radioisotopes or bone surgery, change in antineoplastic therapy to treat bone pain.~Time to SRE was defined as the time from the date of randomization to the date of occurence of the first event defining a SRE or death due to any cause, whichever occurred first.~The median time to SRE and its 95% confidence interval were estimated using the Kaplan-Meier method. In the absence of SRE, the participant was censored at the last date he/she was known to be alive or the study cut-off date, whichever was earlier." (NCT00519285)
Timeframe: From randomization up to the cut-off date (median follow-up of 35.4 months)

Tumor Response Rate in Participants With Measurable Disease

Tumor response was defined as either a Complete Response (disappearance of all target lesions) or a Partial Response (≥30% decrease from baseline in target lesions) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST)version 1.0. (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 months up to tumor progression (≥25% increase) or the cut-off date, whichever occurred first

Change From Baseline in Functional Assessment of Cancer Therapy-Prostate Total Score as a Measure of Health Related Quality of Life

"Functional Assessment of Cancer Therapy-Prostate (FACT-P) is a 39-item participant questionnaire that measures the concerns of patients with prostate cancer. It consists of 5 subscales assessing physical well-being, social/family well-being, emotional well-being, functional well-being, and prostate-specific concerns.~FACT-P total score is the sum of the 5 subscores. It ranges from 0 to 156 with higher score indicating better quality of life." (NCT00519285)
Timeframe: Before randomization (baseline) then every 3 weeks until disease progression or administration of further antitumor therapy, whichever came first

Number of Participants With Adverse Events as a Measure of Safety

"Adverse Events (AE) are any unfavorable and unintended sign, symptom, syndrome or illness observed by the investigator or reported by the participant during the study.~AE were collected at regular intervals throughout the study then graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0)." (NCT00519285)
Timeframe: From first dose of study treatment (aflibercept/placebo or docetaxel whichever came first) to last dose of study treatment (aflibercept/placebo or docetaxel whichever came last) + 30 days

Number of Participants With Positive Anti-aflibercept Antibody Levels as a Measure of Immunogenicity of Aflibercept

"Serum for detection of anti-drug antibodies (ADA) was collected in patients treated in selected centers only. Samples were analyzed using a titer-based, bridging immunoassay developed and validated to detect ADAs in human serum.~Samples with positive antibody levels were further analyzed using a validated, non-quantitative ligand binding assay to detect neutralizing antibodies Ab).~A participant was considered to have positive antibody levels if antibodies were detected above the quantification limits." (NCT00519285)
Timeframe: Pre-dose of cycle 1 (baseline), pre-dose of each every other cycle, then 30 and 90 days after the last administration of the study drug

Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings

(NCT01193244)
Timeframe: Baseline up to EOT (Cycle 61 Day 58)

Overall Survival

Overall survival was calculated from the date of participant randomization to the date of participant death due to any cause. Participants without documentation of death at time of the analysis were censored as of the date the participant was last known to be alive, or the data cutoff date, whichever was earlier. (NCT01193244)
Timeframe: Baseline until death (up to 4.7 years)

Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12

The PSA50 is defined as a decline of at least 50 percent (%) from baseline. (NCT01193244)
Timeframe: Week 12

Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12

The PSA90 is defined as a decline of PSA by 90 percent from baseline. (NCT01193244)
Timeframe: Week 12

Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12

A favorable CTC count was defined as less than <5 counts per 7.5 milliliter (mL) in whole blood. An unfavorable CTC count was defined as greater than or equal to (>=) 5 counts/7.5 mL in whole blood. (NCT01193244)
Timeframe: Week 12

Percentage of Participants With Objective Response

Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. A CR was defined as the disappearance of all target lesions determined by computerized tomography (CT) or MRI. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to <10 millimetre (mm). A PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of longest diameters of non-lymph node lesions and of the short diameter or short axis of lymph nodes. (NCT01193244)
Timeframe: Baseline until disease progression or death, whichever occurred first (approximately up to 4.7 years)

Percentage of Participants With Skeletal Related Events (SRE)

Skeletal related (SRE) event is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence. (NCT01193244)
Timeframe: Baseline up to EOT (approximately up to 4.7 years)

Radiographic Progression-free Survival (rPFS)

rPFS was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause, whichever occurred first. Radiographic disease progression was evaluated by computerized tomography (CT) scan or magnetic resonance imaging (MRI) and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for soft tissue disease and Prostate Cancer Working Group (PCWG2) guidelines for bone disease. Participants who did not reach the endpoint were censored at their last assessment. (NCT01193244)
Timeframe: Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years)

Time to Deterioration in Global Health Status

Global health status deterioration is defined as a drop greater than 16 points from the baseline assessment, confirmed at least 3 weeks later, on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module 30 (EORTC QLQ-C30) index after the score has been linearly transformed to a 0 to 100 scale. EORTC QLQ-C30 consists of 30 questions, where question 1 to 28 can be answered with 1: Not at all, 2: A little, 3: Quite a bit, 4: Very much and question 29 to 30 with 1: Very poor to 7: Excellent. For subscales a high score from 0-100 indicates: high global quality of life, high level of functioning (physical, role, emotional, cognitive, social) or a high level of symptoms (fatigue, nausea, pain, dyspnea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). (NCT01193244)
Timeframe: Baseline until EOT (approximately up to 4.7 years)

Time to Docetaxel Chemotherapy

Time to docetaxel based chemotherapy is defined as the time from randomization to the start of docetaxel based chemotherapy for prostate cancer, regardless of whether the participant received concurrent orteronel or not. Deaths due to disease progression prior to Docetaxel based chemotherapy were considered as events. (NCT01193244)
Timeframe: Baseline until start of docetaxel chemotherapy (up to 4.7 years)

Time to Pain Progression

Time to pain progression was defined as the time from participant randomization to the first assessment date of pain progression. Pain progression was defined as the occurrence of 1 of the following and confirmed by an additional assessment, at least 3 weeks but not more than 5 weeks later: The brief pain inventory-short form (BPI-SF) worst pain score was >=4 with a >=2 point increase over baseline in BPI-SF worst pain score with stable or increased analgesic use; The BPI-SF worst pain score was >=4 but not less than baseline with new or increased (relative to baseline) Step II or Step III analgesic use; The BPI-SF worst pain score was <=3 but not less than baseline with new or increased (relative to baseline) Step III analgesic use. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 100 with lower scores being indicative of less pain or pain interference. (NCT01193244)
Timeframe: Baseline until End of treatment (EOT) (approximately up to 4.7 years)

Time to PSA Progression

Time to PSA progression was defined as time from randomization to a PSA increase of 25 percent and PSA rise of at least 2 nanogram per milliliter (ng/mL) above the lowest value observed post baseline or, if no PSA decline occurred post baseline, compared to baseline PSA. (NCT01193244)
Timeframe: Baseline until the final on treatment assessment or until end of short term follow-up following discontinuation of treatment, whichever occurred later (approximately up to 4.7 years)

Time to SRE

Time to SRE is defined as the time from randomization to SRE, or death due to any cause, whichever comes first. SRE is defined as a fracture or spinal cord compression or the need for radiation or surgery at the site of a prostate cancer metastatic lesion that is substantiated by radiographic or pathologic evidence. (NCT01193244)
Timeframe: Baseline up to EOT (Cycle 61 Day 58)

Time to Subsequent Antineoplastic Therapy

Time to subsequent antineoplastic therapy is defined as the time from randomization to the start of any alternate antineoplastic therapy for prostate cancer. Deaths due to disease progression prior to antineoplastic therapy for prostate cancer are considered as events. Otherwise, time to next therapy is censored at the date of death or the last date the participant was known to be alive or the data cutoff date, whichever is earlier. (NCT01193244)
Timeframe: Baseline until start of subsequent antineoplastic therapy (up to 4.7 years)

Worst Change From Baseline Over Time in Cardiac Ejection Fraction

Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point. (NCT01193244)
Timeframe: Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

(NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation

(NCT01193244)
Timeframe: Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58)

Number of Participants With TEAEs Related to Vital Signs

(NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Number of Participants With TEAEs Related to Weight

(NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3

Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events=death related to an AE. (NCT01193244)
Timeframe: Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58)

Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status

ECOG assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50 percent of waking hours [hrs]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50 percent of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead. Worst change was defined as the worst overall change that occurred in ECOG status at any measured time point during the treatment period. (NCT01193244)
Timeframe: Baseline until EOT (approximately up to 4.7 years)

Percentage of Participants Achieving PSA50 Response at Any Time During the Study

The PSA50 is defined as a decline of PSA by 50 percent from baseline. (NCT01193244)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

Percentage of Participants Achieving PSA90 Response at Any Time During the Study

The PSA90 is defined as a decline of PSA by 90 percent from baseline. (NCT01193244)
Timeframe: Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37

Composite Progression-free Survival (cPFS)

"Defined as the median time from randomization to the earliest of:~Tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST);~Evidence of progression by bone scan, performed after completion of the first 3 cycles, demonstrating the appearance of >=2 new lesions;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression)~Symptomatic progression (for participants without measurable disease);~Other clinical events attributable to prostate cancer that require major interventions; or~Death from any cause~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to composite progressive disease, up to 23.4 months

Composite Progression-free Survival (cPFS) at 12-months

"Data presented are the percentage of participants without disease progression at 12 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 12 months

Composite Progression-free Survival (cPFS) at 6-months

"Data presented are the percentage of participants without disease progression at 6 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 6 months

Composite Progression-free Survival (cPFS) at 9-months

"Data presented are the percentage of participants without disease progression at 9 months.~Participants who were ongoing with no progression or who discontinued treatment for reasons other than progression were censored at date of last assessment. Participants who started new anticancer treatment before progression were censored at date of last assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: 9 months

Objective Response Rate (ORR)

"Objective response is Complete Response (CR) + Partial Response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is a disappearance of all target and non-target lesions; PR is at least a 30% decrease in the sum of the longest diameter of target lesions without new lesions and progression of non-target lesions.~Objective response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100." (NCT00683475)
Timeframe: Baseline to date of progressive disease or death up to 36.3 months

Overall Survival (OS)

Overall survival is defined as the time from randomization to the date of death due to any cause. Participants who were alive at the time of study completion were censored at the time the participant was last known to be alive. (NCT00683475)
Timeframe: First dose to death due to any cause up to 36.3 months

Prostate Specific Antigen (PSA) Response Rate

PSA response rate is defined as the percentage of participants with a decrease in PSA >= 50 percent from baseline. (NCT00683475)
Timeframe: Baseline up to data cut-off date (up to 36.3 months)

Time to Radiographic Evidence of Disease Progression

"Time between date of randomization and earliest date of radiographic progression defined as either:~Tumor progression by RECIST;~Evidence of progression by bone scan;~New skeletal events (New pathologic bone fracture in the region of metastatic disease; New bone lesion requiring radiation or surgery; Spinal cord or nerve root compression).~Participants who were ongoing with no radiographic evidence of disease progression, who discontinued treatment for reasons other than progression,or died before progression were censored at date of last tumor or bone radiographic assessment. Participants who started a new anticancer treatment before progression were censored at date of last tumor or bone radiographic assessment before start of new anti-cancer therapy." (NCT00683475)
Timeframe: Randomization to date of radiographic progression, up to 36.3 months

Summary Listing of Participants Reporting Treatment-Emergent Adverse Events

Data presented are the number of participants who experienced A12 or 1121B (ramucirumab) related treatment-emergent adverse events (TEAE), treatment related serious adverse events (SAE), or any Grade 3 or higher TEAE; any TEAE leading to discontinuation of A12 or 1121B (ramucirumab) treatment, and any TEAE leading to dose modification of A12 or 1121B (ramucirumab). A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Event section. (NCT00683475)
Timeframe: Randomization to 36.3 months

Overall Survival

Overall Survival as measured by the Kaplan-Meier method (NCT01051570)
Timeframe: After treatment, participants will be contacted every 3 months up to 4 years

Pharmacokinetics: Observed Carboplatin AUC Was Estimated Based on the Concentration in the 2.75-h Sample.

Using a limited sampling model (i.e., AUC = 0.52 × C2.75h + 0.92) (Sorensen et al., 1993), observed carboplatin AUC was estimated based on the concentration in the 2.75-h sample. (NCT01051570)
Timeframe: Samples were collected Cycle 2, Day 1

PSA Response Rate

PSA response rate with response defined as => a 30% reduction in PSA (NCT01051570)
Timeframe: Day 1 of each cycle (every 21 days), through study completion, an average of 6 months

Time to Progression (TTP)

Progression defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01051570)
Timeframe: Up to 63 days while on treatment, then up 90 days thereafter. From date of registration to date of progressive disease.

Association of PSA Response Rate With Correlative Markers (Phospho mTOR, pAKT, and p70S6)

PSA response defined as a decrease of 30% or more will be tabled against mTOR, pAKT, and p70S6 (1+, 2+, 3+ vs ND) (NCT01051570)
Timeframe: Archival tissue will be collected if available. Optional biopsies pre-treatment and 24 hours after first everolimus and carboplatin dose

Number of Participants With Toxicity as Measured by NCI CTCAE v3.0 Criteria

Number of Participants with Grade 3/4 Toxicity as measured by NCI CTCAE v3.0 criteria (NCT01051570)
Timeframe: Day 1 of each cycle (every 21 days), through study completion, an average of 6 months

2-year Radiographically Evident Progression-free Survival (REPFS).

"Radiographic progression:~1) For bone scan, 2 unequivocal new lesions confirmed by a subsequent bone scan with at least 1 more new lesion; 2) Skeletal related event (eg, fracture, need for radiation to bone for pain, spinal cord compression, need for surgery to bone to prevent or treat a pathologic fracture)." (NCT00661492)
Timeframe: 24 months.

Median Overall Survival (OS)

OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date. (NCT00661492)
Timeframe: 30 months

Median Progression-free Survival (PFS)

PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. (NCT00661492)
Timeframe: 24 months

Median Time to Progression (TTP)

TTP will be measured from the start of treatment date to the date the patient is first recorded as having disease progression (even in patients who discontinue study treatment early due to toxicity or death due to disease progression. (NCT00661492)
Timeframe: 24 months

Median Time to Prostate-specific Antigen (PSA) Progression

Defined as the time from initiation of therapy until the first 25% increase from baseline in non-responders or 50% increase from nadir in responders as defined above. A minimum increase in the PSA of 5 ng/mL will be required for progression. (NCT00661492)
Timeframe: 24 months

Objective Response Rate (ORR)

ORR = CR + PR 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. (NCT00661492)
Timeframe: 24 months

Prostate-specific Antigen (PSA) Doubling Time

PSA doubling time = [log (2)× t] ÷ [log (final PSA) - log (initial PSA)] (NCT00661492)
Timeframe: 24 months

Prostate-specific Antigen (PSA) Response Rate

Defined as the fraction of patients with a ≥50% reduction in serum PSA confirmed by a second serum PSA at least 3 weeks later (NCT00661492)
Timeframe: 24 months

Number of Participants With Adverse Events

Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module. (NCT01240551)
Timeframe: date treatment consent signed to date off study, approximately 52.5 months

Number of Participants With Present or Not Present Bone Metastasis

Present and not present bone metastasis was determined by sodium fluoride (NaF) PET (positron emission imaging)/CT (computed tomography) imaging. Present bone metastasis is defined as greater than normal bone uptake. Not present bone metastasis is defined as physiological bone uptake of F-18 NaF on PET/CT imaging (i.e. excluding traumatic and degenerative foci of increased F-18 NaF uptake. (NCT01240551)
Timeframe: Single imaging sessions will be acquired at baseline, between 4-6 months and between 10-12 months on emolument.

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

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

Acute Grade 3 or Higher Treatment-related Toxicity Rate.

Number of participants that experienced acute grade 3 or higher, treatment-related toxicity based on CTCAE version 3.0 criteria. (NCT01040624)
Timeframe: 6 months after the completion of radiation therapy

Maximum Tolerated Dose (MTD)

MTD is defined as the dose level at which no more than 1 of 6 patients experiences a dose limiting toxicity (DLT) at the level below that which had two instances of DLT. A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01683994)
Timeframe: Adverse events were assessed from the date treatment consent signed to date off study, approximately 45 months and 14 days for Arm A; 43 months and 14 days for Arm B; 9 months and 11 days for DL1; 27 months and 1 day for DL2; & 11 months & 25 days for DL3

Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone

PFS is the time interval from start of treatment to documented evidence of disease progression or death. Disease progression was assessed by the Response Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions as referenced by the smallest sum on study. Appearance of one or more new lesions on bone scan and/or two consecutive rising prostatic-specific antigen values above the baseline at a minimum of one week intervals. A normal PSA value is 4.0 ng/ml and lower. (NCT01683994)
Timeframe: From start date of treatment until the date of first documented progression, date of death from any cause and up to 40 months, whichever occurred first.

Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline

PSA normal range is 4 ng/ml or lower. Participants with PSA decline of 30% or 50% is the measures for prostate cancer based on conventional reporting metrics. (NCT01683994)
Timeframe: up to 38 months

Number of Participants With a Dose Limiting Toxicities (DLTs)

A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding. (NCT01683994)
Timeframe: First two cycles of treatment (each cycle is 21 days), approximately 42 days.

Disease Free Survival

Measured from date of randomization to date of first observation of recurrence or death due to any cause. Patients without recurrence are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years

Overall Survival

Measured from date of randomization to date of death from any cause. Patient known to be alive are censored at date of last contact. (NCT00004124)
Timeframe: at 10 Years

Compare Qualitative and Quantitative Toxicities of These Regimens in These Patients

Number of patients with adverse events that are related to study drug (NCT00004124)
Timeframe: Up to 22 months from registration

Toxicity and Tolerability of Experimental Arm

Descriptive analysis of observed toxicity and patient reports of tolerating experimental treatment (NCT03261336)
Timeframe: 2 years

Reviews

15 reviews available for prednisone and Adenocarcinoma

Trials

46 trials available for prednisone and Adenocarcinoma