Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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

Further Study Information

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 1,000 medically or surgically castrated male patients with metastatic CRPC who have shown tumor progression and are asymptomatic or mildly symptomatic. The study period will consist of screening, treatment, and follow-up phases. Patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until radiographic progression of disease and/or unequivocal clinical progression. Efficacy evaluations will be performed and safety will be assessed throughout the study. Follow-up will continue for 60 months (5 years) or until patient dies, is lost to follow-up, or withdraws informed consent.

At the interim analysis of overall survival (OS; 43% of death events), the independent data monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of the data pointed to a significant advantage for patients in one arm of the study compared with the other arm thereby unanimously recommending unblinding the study and allowing crossover from the placebo arm to active therapy. Patients currently receiving placebo will be offered crossover therapy to abiraterone acetate. Treatment for patients who were originally randomized to the abiraterone acetate treatment group will not change.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Janssen Research and Development, LLC

Janssen Research & Development, LLC Clinical Trial

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00887198
Information obtained from ClinicalTrials.gov on May 06, 2013

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