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A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC)
Sponsor: Janssen Research & Development, LLC
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
Conditions
Interventions
Apalutamide
Apalutamide 240 mg (4\*60 mg tablets) will be administrated orally once daily.
Placebo
Matching placebo will be administered orally.
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