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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

December 17, 2019

Primary Completion Date

June 1, 2023

Study Completion Date

June 5, 2026

Conditions
Prostatic Neoplasms
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.

Trial Locations (27)

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

100034

Peking University First Hospital, Beijing

100044

Peking University People s Hospital, Beijing

100050

Beijing Friendship Hospital, Beijing

100191

Peking University Third Hospital, Beijing

100730

Beijing Hospital, Beijing

200032

Cancer Hospital, FuDan University, Shanghai

Shanghai Zhongshan Hospital, Shanghai

200040

Huashan Hospital Fudan University, Shanghai

200240

Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai

The Fifth People's Hospital of Shanghai, Fudan University, Shanghai

200400

Huadong Hospital Affiliated to Fudan University, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

214023

Wuxi People s Hospital, Wuxi

215006

First Affiliated Hospital SooChow University, Suzhou

310000

Zhejiang Provincial People's Hospital, Hangzhou

310003

The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

315010

The First Affiliated Hospital of Ningbo University, Ningbo

350001

Fujian Medical University Union Hospital, Fuzhou

400030

Chongqing University Cancer Hospital, Chongqing

410013

Hunan Cancer hospital, Changsha

430030

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

510120

Sun Yat-Sen Memorial Hospital Sun Yat-sen University, Guangzhou

510180

Guangzhou First Municipal People's Hospital, Guangzhou

610072

Sichuan Provincial Peoples Hospital, Chengdu

710061

The First Affiliated Hospital of Xian Jiaotong University, Xi'an

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY