drugset / Trial / NCT00924469
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).
Timeline
- Start
- 2009-11
- Primary completion
- 2012-02
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |
| Background | Leuprolide | Other / unclassified | 22.5 mg | Intramuscular |