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A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate CancerUnique Dataset IDProstat_Janssen_2009_169ClinicalTrial.gov IDNCT00887198
Clinical Trial Title
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone in Asymptomatic or Mildly Symptomatic Subjects With Metastatic Castration-Resistant Prostate Cancer
Trial Summary and Conditions
This is a multinational, randomized, double-blind, placebo-controlled, Phase 3 study conducted at 151 study sites. The study was designed to compare the efficacy and safety of abiraterone acetate plus prednisone with that of placebo plus prednisone in medically or surgically castrated asymptomatic or mildly symptomatic men with mCRPC who have not received cytotoxic chemotherapy. Subjects were stratified according to ECOG performance status Grade (0 versus 1) and were randomly assigned (1:1) to receive abiraterone acetate plus prednisone or placebo plus prednisone. Prednisolone was used in Europe; it was used in Australia when prednisone was not available. Eligible subjects received 1,000 mg of abiraterone acetate (administered as 4 x 250 mg tablets) or 4 placebo tablets once daily plus prednisone 5 mg twice daily. Food was not to be consumed for at least 2 hours before and for at least 1 hour after the dose of study drug. The study consisted of a Screening Period (within 14 days before Cycle 1 Day 1), a Treatment Period (starting at the first dose on Cycle 1 Day 1 and ending with the End-of-Study Treatment Visit), and a Follow-up Period (follow-up for survival every 3 months up to 5 years). Each treatment cycle was 28 calendar days. While treatment was administered on a continuous schedule, each cycle of treatment was defined as 28 calendar days. Dosing compliance was evaluated during the Cycle 1 Day 15 visit, on Day 1 of each subsequent cycle, at treatment discontinuation, if applicable, and at the End-of-Study Treatment Visit. Safety assessments were based on medical history, measurements of vital signs, and physical examinations.
Control arm data files include raw data on safety, efficacy, demographic, and baseline disease characteristics.
The primary objective of this study was to compare the clinical benefit of abiraterone acetate plus prednisone to placebo plus prednisone in men with asymptomatic or mildly symptomatic chemotherapy-na?ve metastatic CRPC. The secondary objectives of this study were to establish additional clinically relevant improvements in prostate cancer subjects treated with abiraterone acetate in comparison with placebo, to characterize the safety profile of abiraterone acetate in this subject population, and to characterize the pharmacokinetics of abiraterone acetate when administered concurrently with prednisone.
The co-primary efficacy endpoints of this study were radiographic progression-free survival (rPFS) and overall survival (OS). The rPFS was defined as the time from randomization to the occurrence of 1 of the following, whichever occurred first: progression by bone scan (according to adapted PCWG2 criteria), progression by CT or MRI (according to modified RECIST criteria), or death. OS was defined as the time from randomization to the date of death (regardless of the cause). Secondary efficacy endpoints included time to opiate use for cancer-related pain, defined as the time interval from the date of randomization to the date of opiate use for prostate cancer pain; time to initiation of cytotoxic chemotherapy for metastatic prostate cancer, defined as the time interval from the date of randomization to the date of initiation of cytotoxic chemotherapy for prostate cancer; time to first clinical deterioration, as assessed by the time interval from the date of randomization to deteriorati
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DATA DICTIONARY: COU-AA-302_Data_Dictionary.pdf
DATA (COMPARATOR ARM): COU-AA-302.zip