| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01193257 | Study Comparing Orteronel Plus Prednisone in Participants With Metastatic Castration-Resistant Prostate Cancer. | PHASE3 | COMPLETED | 1,099 | — | — | Nov 15, 2010 | Feb 29, 2016 | Dec 19, 2018 | 78 | United States, Australia +12 |
| NCT01193244 | Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer | PHASE3 | COMPLETED | 1,560 | — | — | Oct 1, 2010 | Apr 7, 2016 | May 17, 2017 | 240 | United States, Australia +38 |
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.
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.
| Arm | Type | Description |
|---|---|---|
| Orteronel + prednisone | EXPERIMENTAL | - |
| Placebo + prednisone | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Orteronel | DRUG | Orteronel tablets |
| Prednisone | DRUG | Prednisone tablets |
| Orteronel Placebo | DRUG | Orteronel placebo-matching tablets |
| Placebo | DRUG | Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of \<50 ng/dL. |
Inclusion Criteria: Each participant must meet all of the following inclusion criteria: * Voluntary written consent * Male 18 years or older * Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Radiograph-documented metastatic disease * Progressive disease * Prior sur...