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Brief Title: A Study of Apalutamide in Chinese Participants With 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)
Study ID: NCT04108208
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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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 Cancer Hospital, Hang Zhou, , China
Zhejiang Provincial People's Hospital, Hangzhou, , China
The First Affiliated Hospital Zhejiang University College of Medicine, 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, Xian, , China
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR