Overview

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)

Status:
Active, not recruiting
Trial end date:
2021-10-28
Target enrollment:
Participant gender:
Summary
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 and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).
Phase:
Phase 3
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Abiraterone Acetate
Androgens
Ascorbic Acid
Estrogens, Conjugated (USP)
Hormones
Methyltestosterone
Prednisone