Trial · NCT01193257
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Baseline until death (approximately up to 4.5 years) | 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. |
| Secondary | Radiographic Progression-free Survival (rPFS) | Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years) | rPFS was defined as the time from randomization until radiographic disease progression or death due to any cause, whichever occurred first. Radiographic disease progression was defined as the occurrence of 1 or more of the following: The appearance of 2 or more new lesions on radionuclide bone scan as defined by prostate cancer working group (PCWG)2; Should 2 or more new bone lesions be evident at the first assessment (8-week assessment) on treatment, 2 or more additional new lesions must have been evident on a confirmatory assessment at least 6 weeks later; One or more new soft tissue/visceral organ lesions identified by computed tomography (CT)/magnetic resonance imaging (MRI); Progression as defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria. |
| Secondary | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50 Response) at Week 12 | Week 12 | The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50 percent (%) from baseline. |
| Secondary | Percentage of Participants With Pain Response at Week 12 | Week 12 | Pain response 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: A greater than or equal to (\>=) 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use; or a 25 percent (%) or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. |
| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With Abnormal Physical Examination Findings | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With TEAEs Related to Vital Signs | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With TEAEs Related to Weight | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status | Baseline up to End-of-treatment (EOT) (Cycle 59 Day 58) | 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% 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% 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. |
| Secondary | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Cycle 59 Day 58 | |
| Secondary | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Steroid Hormone Panel | Baseline up to 30 days after last dose of study drug (Cycle 59 Day 58) | |
| Secondary | Percentage of Participants Achieving PSA50 Response at Any Time During the Study | Cycle: 4, 7, 10, 13, 16, 19, 22, and 25 | The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. |
| Secondary | Percentage of Participants Achieving 90 Percent Reduction From Baseline in Prostate Specific Antigen (PSA90 Response) at Week 12 | Week 12 | The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline. |
| Secondary | Percentage of Participants Achieving PSA90 Response at Any Time During the Study | Cycle: 7, 10, 13, 16, 19, 22, and 25 | The PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline. |
| Secondary | Best PSA Response at Any Time During the Study | Cycle: 4, 7, 10, 13, 16, 19, 22, and 25 | The PSA50 was defined as the percentage of participants who had a PSA decline of at least 50% from baseline. PSA90 was defined as the percentage of participants who had a PSA decline of at least 90% from baseline. |
| Secondary | Time to PSA Progression | 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 4.5 years) | Time to PSA progression was defined as time from randomization to a PSA increase of 25% 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, above the baseline PSA. |
| Secondary | Number of Participants With Shifts From Baseline Between Favorable and Unfavorable Categories in Circulating Tumor Cell Count (CTC) | Baseline and EOT (Cycle 59 Day 58) | A favorable CTC count was defined as less than (\<) 5 counts per (/) 7.5 mililiter (mL) in whole blood. An unfavorable CTC count was defined as \>=5 counts/7.5 mL in whole blood. |
| Secondary | Percentage of Participants With Objective Response | Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years) | Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. The overall objective response was defined as a complete response (CR) or partial response (PR). A complete response (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(s) or short axis of lymph nodes. |
| Secondary | Time to Pain Progression | Baseline until EOT visit or until end of short term follow-up, whichever occurred later (approximately up to 4.5 years) | 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. |
| Secondary | Time to Pain Response | Baseline until disease progression or death, whichever occurred first (approximately up to 4.5 years) | Time to pain response was defined as the time from randomization until first pain response. Pain response 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: A \>= 2 point reduction from baseline in BPI-SF worst pain score without an increase in analgesic use, or a 25% or more reduction in analgesic use from baseline without an increase in worst pain score from baseline. The analysis was performed by Kaplan-Meier method. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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