Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Trial ID or NCT#
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).
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
- - 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
- - 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
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Cancer Clinical Trials Office