A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
1 other identifier
interventional
654
4 countries
67
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started May 2018
Typical duration for phase_3 prostate-cancer
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2018
CompletedFirst Posted
Study publicly available on registry
May 9, 2018
CompletedStudy Start
First participant enrolled
May 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedMarch 2, 2021
February 1, 2021
4.9 years
April 27, 2018
February 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
rPFS
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Approximately 70 months
OS
Time from randomisation to death due to any cause
Approximately 70 months
Secondary Outcomes (4)
Time to prostate specific antigen (PSA) progression
Approximately 70 months
Time to skeletal-related events
Approximately 70 months
Objective response rate (ORR)
Approximately 70 months
Time to initiation of a new antineoplastic therapy
Approximately 70 months
Study Arms (2)
SHR3680
EXPERIMENTALParticipants will receive SHR3680 orally
bicalutamide
ACTIVE COMPARATORParticipants will receive bicalutamide orally
Interventions
Eligibility Criteria
You may qualify if:
- Age≧18 year, male;
- ECOG performance scale 0 to 1;
- Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ;
- Adequate hepatic, renal, heart, and hematological functions;
- Patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
You may not qualify if:
- Subject has received any prior radiation therapy or surgery for prostate cancer, except 1 course of palliative surgical therapy if it was used at least 4 weeks prior to day 1;
- Previous use or are using a second-generation androgen receptor antagonist (enzalutamide, ARN-509, ODM-201), abiraterone, ketoconazole for prostate cancer, or other agents that will inhibit the production of androgens;
- Have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks prior to day 1: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease PSA levels ;
- Evidence of brain metastasis or primary tumors;
- Planned to initiate any other anti-tumor therapies during the study;
- Unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; Clinically significant cardiovascular diseases;
- History of seizure or certain conditions that may predispose to seizure;
- Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
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.
Pilsen, Plzeň, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Fakultni nemocnice Olomouc
Pavlov, Czechia
Nemocnice Na Homolce
Prague, 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
Piotrkow Trybunalski, Poland
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
Słupsk, Poland
Related Publications (3)
Wang H, Jiang S, Luo H, Zhou F, He D, Ma L, Guo H, Liang C, Chong T, Jiang J, Chen Z, Wang Y, Zou Q, Tian Y, Xiao J, Huang J, Chen J, Dong Q, Zhang X, Li H, Yang X, Lian J, Wang W, Ye D. Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study. Signal Transduct Target Ther. 2024 Dec 18;9(1):351. doi: 10.1038/s41392-024-02064-z.
PMID: 39690158DERIVEDBian X, Gu W, Zhang X, Xie L, Wang S, Shi B, Sun T, Wei S, Weng Z, Xia S, Han B, Xu Z, Xing J, Zhang D, Xu D, Du C, He C, Wang Q, Yang X, Lian J, Wang W, Ye D. Correlation of PSA and survival in metastatic hormone-sensitive prostate cancer treated with rezvilutamide plus ADT in the CHART trial. Med. 2025 Feb 14;6(2):100520. doi: 10.1016/j.medj.2024.09.009. Epub 2024 Oct 16.
PMID: 39419035DERIVEDGu W, Han W, Luo H, Zhou F, He D, Ma L, Guo H, Liang C, Chong T, Jiang J, Chen Z, Wang Y, Zou Q, Tian Y, Xiao J, Huang J, Zhu S, Dong Q, Zhang X, Li H, Yang X, Chen C, Li J, Jin C, Zhang X, Ye D; CHART Investigators. Rezvilutamide versus bicalutamide in combination with androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer (CHART): a randomised, open-label, phase 3 trial. Lancet Oncol. 2022 Oct;23(10):1249-1260. doi: 10.1016/S1470-2045(22)00507-1. Epub 2022 Sep 5.
PMID: 36075260DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dingwei Ye, M.D.
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2018
First Posted
May 9, 2018
Study Start
May 30, 2018
Primary Completion
April 30, 2023
Study Completion
April 30, 2025
Last Updated
March 2, 2021
Record last verified: 2021-02