A randomized study of apalutamide in Chinese patients with non-metastatic castration-resistant prostate cancer.

ABSTRACT: This post-approval commitment study addressed the limited data on the safety and efficacy of apalutamide in Chinese patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Utilizing a double-blinded, placebo-controlled trial with pre-planned crossover design, 75 patients were randomized (2:1) to receive apalutamide 240 mg daily or placebo while continuing androgen deprivation therapy. Apalutamide significantly reduced the risk of prostate-specific antigen (PSA) progression by 76.7% compared with placebo (hazard ratio [HR] = 0.233, p = 0.0052), with confirmed PSA response rate of 92.0% versus 12.0%. The median metastasis-free survival with apalutamide was 36.8 months, while the median overall survival was not reached. Grade 3 and 4 treatment-emergent adverse even

SUBMITTER: Jiang S 

PROVIDER: S-EPMC12355417 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature