ARN-509 Chemo-naïve Indicated Subjects
A Phase 3 Randomized, Multicenter, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naive Metastatic Castration-resistant ProstateCancer (mCRPC).
JNJ-56021927 (also referred to as ARN-509) is an orally available, small molecule, non-steroidal potent and selective antagonist of the androgen receptor (AR) receptor (anti-androgen). It is currently being developed for the treatment of castration-resistant prostate cancer (CRPC).
The primary objective is to compare the radiographic progression-free survival (rPFS) of JNJ-56021927
in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in subjects with chemotherapy-naïve mCRPC.
Radiographic progression-free survival is defined as the time from date of randomization to the date of radiographic progression or death, whichever occurs first.
Overall survival (OS), time to chronic opioid use, time to initiation of cytotoxic chemotherapy, and time to pain progression.
Participants’ safety will be monitored throughout the study.