Spots Global Cancer Trial Database for A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
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Trial Identification
Brief Title: A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
Official Title: A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
Study ID: NCT03520478
Study Description
Brief Summary: The aim of this study is to compare the safety and efficacy of SHR3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.
Detailed Description: This is an open, multicenter, randomized phase III trial. This clinical study compares the efficacy and safety of SHR3680 with bicalutamide in the patients with hormone sensitive prostate cancer. Approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to SHR3680 or bicalutamide treatment. Primary endpoints of the study are radiological progress-free survival (rPFS) and overall survival (OS).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Complex oncological center - Bourgas, Burgas, , Bulgaria
UMHAT 'Deva Maria'. EOOD, Burgas, , Bulgaria
MHAT - Dobrich. AD, Dobrich, , Bulgaria
MHAT 'Dr. Tota Venkova'. AD, Gabrovo, , Bulgaria
Complex Oncological Center - Plovdiv. EOOD, Plovdiv, , Bulgaria
MHAT 'Central Onco Hospital'. OOD, Plovdiv, , Bulgaria
Acibadem City Clinic Tokuda Hospital Ead, Sofia, , Bulgaria
Affiliated Hospital of Hebei University, Baoding, , China
Beijing Cancer Hospital, Beijing, , China
Beijing Friendship Hospital, Capital Medical University, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
The third hospital of Peking University, Beijing, , China
Tumor Hospital of the Chinese Academy of Medical Sciences, Beijing, , China
China Japan Friendship Hospital of Jilin University, Changchun, , China
The first hospital of Jilin University, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
West China Hospital of Sichuan University, Chengdu, , China
Army characteristic medical center of the Chinese people's Liberation Army, Chongqing, , China
Chongqing Cancer Hospital, Chongqing, , China
The First Affiliated Hospital of Army Medical University, Chongqing, , China
The First Affiliated Hospital of Fujian Medical University, Fuzhou, , China
Sun Yat-Sen hospital of Sun Yat-Sen University, Guangzhou, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
The First Affiliated Hospital of Zhejiang University Medicine college, Hangzhou, , China
The Second affiliated hospital of zhejiang university medical college, Hangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Zhejiang Province People's Hospital, Hangzhou, , China
Anhui Provincial Hospital, Hefei, , China
The First Affiliated Hospital of Anhui Medical University, Hefei, , China
Qilu Hospital of Shandong University, Jinan, , China
Yunnan Provincial Cancer Hospital, Kunming, , China
The second hospital of Lanzhou University, Lanzhou, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
Gulou Hospital Affiliated to Medical College of Nanjing University, Nanjing, , China
Jiangsu Provincial Cancer Hospital, Nanjing, , China
Jiangsu Provincial People's Hospital, Nanjing, , China
Huadong Hospital of Fudan University, Shanghai, , China
Ruijin Hospital, Shanghai, , China
Shanghai General Hospital, Shanghai, , China
The Cancer Hospital of Fudan University, Shanghai, , China
Zhongshan Hospital of Fudan University, Shanghai, , China
Liaoning Provincial Cancer Hospital, Shenyang, , China
The fourth hospital of Hebei Medical University, Shijia Zhuang, , China
The second hospital of Tianjin Medical University, Tianjing, , China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, , China
Hubei Provincial Cancer Hospital, Wuhan, , China
Tongji Hospital, Tongji medical college of HUST, Wuhan, , China
Union Hospital, Tongji Medical college of HUST, Wuhan, , China
Wuxi People's Hospital, Wuxi, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
Jiangsu Subei people's Hospital, Yangzhou, , China
Henan people's Hospital, Zhengzhou, , China
Henan Provincial Cancer Hospital, Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
RESEARCH SITE s.r.o., Plzen, Plzeň, Czechia
Fakultni nemocnice u sv. Anny v Brne, Brno, , Czechia
Fakultni nemocnice Olomouc, Pavlov, , Czechia
Nemocnice Na Homolce, Praha, , Czechia
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z., Ústí Nad Labem, , Czechia
Beskidzkie Centrum Onkologii im.Jana Pawla II, Bielsko-Biala, Bielsko-Biała, Poland
LexMedica Osrodek Badan Klinicznych, Wesoła, Weigla, Poland
KO-MED Centra Kliniczne Biala Podlaska, Biała Podlaska, , Poland
Swietokrzyskie Centrum Onkologii, Kielce, , Poland
Provita Profamilia, Piotrków Trybunalski, , Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka, Słupsk, , Poland
Contact Details
Name: Dingwei Ye, M.D.
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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