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Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer - NCT00887198-06520(Clinical Trial 349704)



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City:  New Haven
State:  
CT
Zip Code: 06520
Conditions: Prostate Cancer
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: - Metastatic castration-resistant prostate cancer - 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 - Able to provide written informed consent 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 Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria. Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.
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Data Source: ClinicalTrials.gov
Date Processed: May 21, 2010
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