OncRef

Clinical Trial: NCT04108208

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

Status:

COMPLETED

Phase:

Phase 4

Lead Sponsor:Janssen Research & Development, LLC
Information Provided By:Janssen Research & Development, LLC
Last Update Posted:2026-07-30

Study Overview

Brief 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).

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IV Study of Apalutamide in Chinese Participants With Non-Metastatic Castration-Resistant Prostate Cancer (NM-CRPC)

Conditions

Prostatic Neoplasms

Intervention / Treatment

  • Drug: Apalutamide
  • Drug: Placebo
  • Drug: Androgen-deprivation Therapy (ADT)

Other Study ID Numbers

  • CR108660
  • 56021927PCR4007

Start Date (Actual)

2019-12-17

Primary Completion Date (Actual)

2023-06-01

Study Completion Date (Actual)

2026-06-05

Enrollment (Actual)

75

Study Type

Interventional

Phase

Phase 4