Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Trial end date: 2017-05-25
• Target enrollment: 0
• Participant gender: Male

Summary

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Prednisone

Criteria

Inclusion Criteria:

• Metastatic castration-resistant prostate cancer (CRPC)

• Previous anti-androgen therapy and progression after withdrawal

• ECOG performance status of either 0 or 1

• Medical or surgical castration with testosterone less than 50 ng/dL

• Life expectancy of at least 6 months

Exclusion Criteria:

• Prior cytotoxic chemotherapy or biologic therapy for CRPC

• Prior ketoconazole for prostate cancer

• Known brain metastasis or visceral organ metastasis

• Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1