A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

NCT01715285 PHASE3 COMPLETED Results posted

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone \[LHRH\] agonists or surgical castration).

Details

Lead sponsor	Janssen Research & Development, LLC
Phase	PHASE3
Status	COMPLETED
Enrolment	1209
Start date	Tue Feb 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Sun Feb 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Prostate Neoplasms

Interventions

• Abiraterone acetate
• Prednisone
• Androgen deprivation therapy (ADT)
• Abiraterone acetate Placebo
• Prednisone Placebo

Countries

Colombia, Finland, Japan, Malaysia, Poland, South Korea, Denmark, New Zealand, Netherlands, Russia, Belgium, Sweden, Mexico, Bulgaria, Portugal, France, South Africa, Slovakia, Chile, Israel, Hungary, Argentina, Canada, Romania, Brazil, Spain, Ukraine, United Kingdom, Germany, Australia