A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03520478
• Other study ID #: SHR-3680-III-HSPC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 30, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 654
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hormone-Dependent Prostate Cancer
• Hypersensitivity
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• SHR3680
Tablet. Specifications of 80 mg; orally, once a day
• Bicalutamide
Tablet. Specifications of 50 mg; orally, once a day

Locations

Country	Name	City	State
Bulgaria	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
China	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
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno
Czechia	Fakultni nemocnice Olomouc	Pavlov
Czechia	RESEARCH SITE s.r.o.	Plzen	Plzen
Czechia	Nemocnice Na Homolce	Praha
Czechia	Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.	Ústí Nad Labem
Poland	KO-MED Centra Kliniczne Biala Podlaska	Biala Podlaska
Poland	Beskidzkie Centrum Onkologii im.Jana Pawla II	Bielsko-Biala	Bielsko-Biala
Poland	Swietokrzyskie Centrum Onkologii	Kielce
Poland	Provita Profamilia	Piotrków Trybunalski
Poland	Wojewodzki Szpital Specjalistyczny im. J. Korczaka	Slupsk
Poland	LexMedica Osrodek Badan Klinicznych	Wesola	Weigla

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Countries where clinical trial is conducted

Bulgaria,  China,  Czechia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rPFS	Time from randomisation to radiologically confirmed progressive disease or death due to any cause	Approximately 70 months
Primary	OS	Time from randomisation to death due to any cause	Approximately 70 months
Secondary	Time to prostate specific antigen (PSA) progression	Time from randomisation to the first time of PSA progression according to the criterion of PCGW3	Approximately 70 months
Secondary	Time to skeletal-related events	Time from randomisation to the first occurrence of a fracture or treatment for the fracture. The skeletal-related event is defined as the occurrence of either pathological or clinical fracture, spinal cord compression, bone-related radiotherapy or surgery	Approximately 70 months
Secondary	Objective response rate (ORR)	The percentage of subjects with measureable disease at baseline who achieved a complete or partial response in their soft tissue disease using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria	Approximately 70 months
Secondary	Time to initiation of a new antineoplastic therapy	Time from randomisation to the initiation of antineoplastic subsequent to the study treatment	Approximately 70 months