Trial · NCT01193244
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Radiographic Progression-free Survival (rPFS) | Baseline until radiographic disease progression or death, whichever occurred first (approximately up to 4.7 years) | 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. |
| Primary | Overall Survival | Baseline until death (up to 4.7 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 | Percentage of Participants Achieving 50 Percent Reduction From Baseline in Prostate Specific Antigen (PSA50) Response at Week 12 | Week 12 | The PSA50 is defined as a decline of at least 50 percent (%) from baseline. |
| Secondary | Percentage of Participants With Favorable Circulating Tumor Cell Count (CTC) Levels at Week 12 | 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. |
| Secondary | Time to Pain Progression | Baseline until End of treatment (EOT) (approximately up to 4.7 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. 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. |
| Secondary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events Greater Than or Equal to (>=) Grade 3 | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | 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. |
| Secondary | Number of Participants With TEAEs Related to Vital Signs | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | |
| Secondary | Number of Participants With TEAEs Related to Weight | Baseline up to 30 days after last dose of study drug (Cycle 61 Day 58) | |
| Secondary | Number of Participants With Worst Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status | Baseline until EOT (approximately up to 4.7 years) | 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. |
| Secondary | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Baseline up to EOT (Cycle 61 Day 58) | |
| Secondary | Worst Change From Baseline Over Time in Cardiac Ejection Fraction | Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58) | Worst change was defined as the worst overall change that occurred in cardiac ejection fraction at any measured time point. |
| Secondary | Number of Participants With TEAEs Categorized Into Investigations Related to Chemistry, Hematology or Coagulation | Baseline up to 30 days or EOT whichever is later (approximately up to Cycle 61 Day 58) | |
| Secondary | Percentage of Participants With Skeletal Related Events (SRE) | Baseline up to EOT (approximately up to 4.7 years) | 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. |
| Secondary | Time to SRE | Baseline up to EOT (Cycle 61 Day 58) | 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. |
| Secondary | Percentage of Participants Achieving PSA50 Response at Any Time During the Study | Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37 | The PSA50 is defined as a decline of PSA by 50 percent 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 is defined as a decline of PSA by 90 percent from baseline. |
| Secondary | Percentage of Participants Achieving PSA90 Response at Any Time During the Study | Cycle: 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 and 37 | The PSA90 is defined as a decline of PSA by 90 percent 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 4.7 years) | 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. |
| Secondary | Time to Docetaxel Chemotherapy | Baseline until start of docetaxel chemotherapy (up to 4.7 years) | 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. |
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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