- An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) — Active Not Recruiting • Phase III • Oncology • NCT02257736.
- Adding apalutamide to standard hormone therapy improves progression-free survival in men with advanced prostate cancer.
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The purpose of this study is to compare the radiographic progression-free survival (rPFS) of apalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone (AAP) and AAP in participants with chemotherapy-naive (participants who did not receive any chemotherapy [treatment of cancer using drugs]) metastatic castration-resistant prostate cancer (mCRPC) (cancer of prostate gland [gland that makes fluid that aids movement of sperm]). Conditions: Prostatic Neoplasms Interventions: Apalutamide, Abiraterone acetate, Prednisone, Placebo Lead Sponsor: Aragon Pharmaceuticals, Inc. Planned Enrollment: 982 participants