A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy
This is a randomized (the treatment group is assigned by chance), double-blind (neither
physician nor patient knows the treatment that the patient receives) 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 with a randomization allocation ratio of 2:1 between the
abiraterone acetate group (abiraterone acetate plus prednisone) and the placebo group
(placebo plus prednisone). Approximately 200 (133 in the abiraterone acetate group and 67 in
the placebo group) medically or surgically castrated male patients with mCRPC who have
failed docetaxel-based chemotherapy will be enrolled in this study for up to 27 months. The
study protocol includes the following phases: screening (within 28 days prior to
randomization on Cycle 1 Day 1), double-blind treatment (28-day cycles until
protocol-defined disease progression or unacceptable toxicity), and survival follow-up (up
to Month 60). During the follow-up phase, patients with disease progression will be provided
open-label (identity of assigned study drug will be known) extension treatment with
abiraterone acetate. Abiraterone acetate 1000 mg tablets or placebo will be taken orally (by
mouth) once daily plus prednisone 5 mg tablet orally twice daily. Efficacy and safety will
be monitored throughout the study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Time to prostate specific antigen (PSA) progression (TTPP)
From randomization to the time of PSA progression (up to Month 27)
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
China: Food and Drug Administration
CR100010
NCT01695135
August 2012
August 2015
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