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ACTIVE NOT RECRUITING
NCT04108208
PHASE4

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2019-12-17

Completion Date

2026-06-05

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

DRUG

Apalutamide

Apalutamide 240 mg (4\*60 mg tablets) will be administrated orally once daily.

DRUG

Placebo

Matching placebo will be administered orally.

DRUG

Androgen-deprivation Therapy (ADT)

Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.

Locations (27)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Beijing Friendship Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Beijing Hospital

Beijing, China

Hunan Cancer hospital

Changsha, China

Sichuan Provincial Peoples Hospital

Chengdu, China

Chongqing University Cancer Hospital

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

Sun Yat-Sen Memorial Hospital Sun Yat-sen University

Guangzhou, China

Guangzhou First Municipal People's Hospital

Guangzhou, China

Zhejiang Provincial People's Hospital

Hangzhou, China

The First Affiliated Hospital Zhejiang University College of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Nanjing Drum Tower Hospital

Nanjing, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

Cancer Hospital, FuDan University

Shanghai, China

Shanghai Zhongshan Hospital

Shanghai, China

Huashan Hospital Fudan University

Shanghai, China

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

The Fifth People's Hospital of Shanghai, Fudan University

Shanghai, China

Huadong Hospital Affiliated to Fudan University

Shanghai, China

First Affiliated Hospital SooChow University

Suzhou, China

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Wuhan, China

Wuxi People s Hospital

Wuxi, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China