A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)
This is a randomized (the treatment group is assigned by chance), double-blind (neither
physician nor patient knows the treatment that the patient receives), placebo (an inactive
substance that is compared with a drug to test whether the drug has a real effect in a
clinical trial)-controlled study designed to determine if newly diagnosed (within previous 3
months) patients with mHNPC who have high-risk prognostic factors will benefit from the
addition of abiraterone acetate and low-dose prednisone to ADT (LHRH agonists or surgical
castration). Approximately 1270 patients will be enrolled in this study. Patients will be
stratified by presence of visceral disease and Eastern Cooperative Oncology Group
performance grade prior to randomization. The study protocol consists of the following
phases: screening, double-blind treatment, and follow-up phase of up to 60 months to monitor
survival status and subsequent prostate cancer therapy. Patients will be randomized in a 1:1
ratio to the active treatment group (abiraterone acetate 1000 mg daily plus prednisone 5 mg
daily plus ADT) or the control group (ADT plus placebos). Treatment in 28-day cycles will
continue until disease progression or the occurrence of unacceptable toxicity. Patients will
be monitored for efficacy and safety throughout the study. Two interim analyses and a final
analysis are planned for this study. In the event of a positive study result at either of
the interim analyses or at the time of the final analysis, all participants will have the
opportunity to enroll in an open-label extension phase that will allow participants to
receive active drug (abiraterone acetate plus prednisone) for up to 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Overall survival
Up to the time of death from any cause (up to Month 60)
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR100900
NCT01715285
February 2013
July 2018
Name | Location |
---|