At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,088 enrolled
Drug / intervention
Abiraterone acetate +2 moredrug
Likely dose
Abiraterone acetate 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Abiraterone acetate, Placebo, and 1 other intervention for Prostate Cancer. Completed, enrolled 1,088 participants across 134 sites in 11 countries.
Detailed Summary
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Belgium, Canada, France, Germany, Greece, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartApr 2009
Primary CompletionMar 2014
Study CompletionMay 2017
TodayJul 2026
First PostedApr 23, 2009
Enrollment StartApr 28, 2009
Primary CompletionMar 31, 2014
Study CompletionMay 25, 2017
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 17.2 years ago
Interventions
Abiraterone acetatedrug
1000 mg per day (4 x 250-mg tablets) taken orally.
Placebodrug
4 placebo tablets per day taken orally.
Prednisonedrug
5 mg tablet orally twice daily.