A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
This is an open-label (all people know the identity of the intervention), multicenter,
single arm (only one treatment group) study to evaluate the efficacy and safety of
abiraterone acetate in patients with mCRPC. The study will be divided into screening phase
(up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of
treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled
into this study. Safety evaluations for adverse events, clinical laboratory tests,
electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug)
assessments will be conducted in this study. Patients will continue to receive abiraterone
acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Prostate specific antigen (PSA) response rate
PSA response rate is defined as the number of patients achieving a PSA decline of at least 50% according to the Prostate-Specific Antigen Working Group (PSAWG) criteria.
Day 1 of treatment Cycles until the date of first documented PSA progression, lost to follow Up or withdrawn consent, as assessed up to 9 months after the last patient is enrolled
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Taiwan: Taiwan Food and Drug Administration