Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

Prostate Cancer Clinical Trial

Official title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

Clinical Trial Description

This is a multinational, multicenter, randomized (the study drug is assigned by chance), double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study. All patients will be randomly assigned in a 1:1 ratio between the abiraterone acetate group (abiraterone acetate and prednisone) and the placebo group (placebo and prednisone). The study will consist of a screening phase (within 28 days prior randomization on Cycle 1, Day 1), a treatment phase (28-day cycles until disease progression), and a follow-up phase (all patients will be contacted for every 3 months up to Month 60, focusing primarily on survival status). Patients will receive either abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily or placebo and prednisone 5 mg twice daily. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01591122
• Study type: Interventional
• Source: Janssen Research & Development, LLC
• Status: Completed
• Phase: Phase 3
• Start date: March 27, 2012
• Completion date: January 31, 2019