A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)

Summary

The purpose of this study is to compare the improvement in time to prostate specific antigen (PSA) progression (TTPP, as defined by Prostate Cancer Working Group 2 \[PCWG2\]) of apalutamide versus placebo in Chinese participants with high-risk non-metastatic castration resistant prostate cancer (NM-CRPC).

Timeline

Start

2019-12-17

Primary completion

2023-06-01

Completion

2026-06-05

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo Plus Androgen-deprivation Therapy (ADT) vs Apalutamide 240 mg Plus ADT; p =0.0052; Hazard Ratio (HR) 0.233 (95% CI 0.077 to 0.705); Log Rank NCT04108208 ↗

Drugs

Indications