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

Primary Purpose

Prostate Cancer, Hormone-Dependent Prostate Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SHR3680
Bicalutamide
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone sensitive prostate cancer, SHR3680, Anti-androgen receptor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Sites / Locations

  • Complex oncological center - Bourgas
  • UMHAT 'Deva Maria'. EOOD
  • MHAT - Dobrich. AD
  • MHAT 'Dr. Tota Venkova'. AD
  • Complex Oncological Center - Plovdiv. EOOD
  • MHAT 'Central Onco Hospital'. OOD
  • Acibadem City Clinic Tokuda Hospital Ead
  • Affiliated Hospital of Hebei University
  • Beijing Cancer Hospital
  • Beijing Friendship Hospital, Capital Medical University
  • Peking Union Medical College Hospital
  • The third hospital of Peking University
  • Tumor Hospital of the Chinese Academy of Medical Sciences
  • China Japan Friendship Hospital of Jilin University
  • The first hospital of Jilin University
  • Hunan Cancer Hospital
  • West China Hospital of Sichuan University
  • Army characteristic medical center of the Chinese people's Liberation Army
  • Chongqing Cancer Hospital
  • The First Affiliated Hospital of Army Medical University
  • The First Affiliated Hospital of Fujian Medical University
  • Sun Yat-Sen hospital of Sun Yat-Sen University
  • Sun Yat-sen University Cancer Center
  • The First Affiliated Hospital of Zhejiang University Medicine college
  • The Second affiliated hospital of zhejiang university medical college
  • Zhejiang Cancer Hospital
  • Zhejiang Province People's Hospital
  • Anhui Provincial Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Qilu Hospital of Shandong University
  • Yunnan Provincial Cancer Hospital
  • The second hospital of Lanzhou University
  • The First Affiliated Hospital of Nanchang University
  • Gulou Hospital Affiliated to Medical College of Nanjing University
  • Jiangsu Provincial Cancer Hospital
  • Jiangsu Provincial People's Hospital
  • Huadong Hospital of Fudan University
  • Ruijin Hospital
  • Shanghai General Hospital
  • The Cancer Hospital of Fudan University
  • Zhongshan Hospital of Fudan University
  • Liaoning Provincial Cancer Hospital
  • The fourth hospital of Hebei Medical University
  • The second hospital of Tianjin Medical University
  • The First Affiliated Hospital of Wenzhou Medical University
  • Hubei Provincial Cancer Hospital
  • Tongji Hospital, Tongji medical college of HUST
  • Union Hospital, Tongji Medical college of HUST
  • Wuxi People's Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The Second Affiliated Hospital of Xi'an Jiaotong University
  • The First Affiliated Hospital of Xiamen University
  • Jiangsu Subei people's Hospital
  • Henan people's Hospital
  • Henan Provincial Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • RESEARCH SITE s.r.o.
  • Fakultni nemocnice u sv. Anny v Brne
  • Fakultni nemocnice Olomouc
  • Nemocnice Na Homolce
  • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
  • Beskidzkie Centrum Onkologii im.Jana Pawla II
  • LexMedica Osrodek Badan Klinicznych
  • KO-MED Centra Kliniczne Biala Podlaska
  • Swietokrzyskie Centrum Onkologii
  • Provita Profamilia
  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SHR3680

bicalutamide

Arm Description

Participants will receive SHR3680 orally

Participants will receive bicalutamide orally

Outcomes

Primary Outcome Measures

rPFS
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
OS
Time from randomisation to death due to any cause

Secondary Outcome Measures

Time to prostate specific antigen (PSA) progression
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
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
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
Time to initiation of a new antineoplastic therapy
Time from randomisation to the initiation of antineoplastic subsequent to the study treatment

Full Information

First Posted
April 27, 2018
Last Updated
February 28, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03520478
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 Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Hormone-Dependent Prostate Cancer
Keywords
Hormone sensitive prostate cancer, SHR3680, Anti-androgen receptor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
654 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SHR3680
Arm Type
Experimental
Arm Description
Participants will receive SHR3680 orally
Arm Title
bicalutamide
Arm Type
Active Comparator
Arm Description
Participants will receive bicalutamide orally
Intervention Type
Drug
Intervention Name(s)
SHR3680
Intervention Description
Tablet. Specifications of 80 mg; orally, once a day
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Intervention Description
Tablet. Specifications of 50 mg; orally, once a day
Primary Outcome Measure Information:
Title
rPFS
Description
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Time Frame
Approximately 70 months
Title
OS
Description
Time from randomisation to death due to any cause
Time Frame
Approximately 70 months
Secondary Outcome Measure Information:
Title
Time to prostate specific antigen (PSA) progression
Description
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
Time Frame
Approximately 70 months
Title
Time to skeletal-related events
Description
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
Time Frame
Approximately 70 months
Title
Objective response rate (ORR)
Description
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
Time Frame
Approximately 70 months
Title
Time to initiation of a new antineoplastic therapy
Description
Time from randomisation to the initiation of antineoplastic subsequent to the study treatment
Time Frame
Approximately 70 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dingwei Ye, M.D.
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complex oncological center - Bourgas
City
Burgas
Country
Bulgaria
Facility Name
UMHAT 'Deva Maria'. EOOD
City
Burgas
Country
Bulgaria
Facility Name
MHAT - Dobrich. AD
City
Dobrich
Country
Bulgaria
Facility Name
MHAT 'Dr. Tota Venkova'. AD
City
Gabrovo
Country
Bulgaria
Facility Name
Complex Oncological Center - Plovdiv. EOOD
City
Plovdiv
Country
Bulgaria
Facility Name
MHAT 'Central Onco Hospital'. OOD
City
Plovdiv
Country
Bulgaria
Facility Name
Acibadem City Clinic Tokuda Hospital Ead
City
Sofia
Country
Bulgaria
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Facility Name
The third hospital of Peking University
City
Beijing
Country
China
Facility Name
Tumor Hospital of the Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
China Japan Friendship Hospital of Jilin University
City
Changchun
Country
China
Facility Name
The first hospital of Jilin University
City
Changchun
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Facility Name
Army characteristic medical center of the Chinese people's Liberation Army
City
Chongqing
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
Country
China
Facility Name
The First Affiliated Hospital of Army Medical University
City
Chongqing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
Country
China
Facility Name
Sun Yat-Sen hospital of Sun Yat-Sen University
City
Guangzhou
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
Country
China
Facility Name
The First Affiliated Hospital of Zhejiang University Medicine college
City
Hangzhou
Country
China
Facility Name
The Second affiliated hospital of zhejiang university medical college
City
Hangzhou
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Facility Name
Zhejiang Province People's Hospital
City
Hangzhou
Country
China
Facility Name
Anhui Provincial Hospital
City
Hefei
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
Country
China
Facility Name
Yunnan Provincial Cancer Hospital
City
Kunming
Country
China
Facility Name
The second hospital of Lanzhou University
City
Lanzhou
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Gulou Hospital Affiliated to Medical College of Nanjing University
City
Nanjing
Country
China
Facility Name
Jiangsu Provincial Cancer Hospital
City
Nanjing
Country
China
Facility Name
Jiangsu Provincial People's Hospital
City
Nanjing
Country
China
Facility Name
Huadong Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
Country
China
Facility Name
The Cancer Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
Country
China
Facility Name
Liaoning Provincial Cancer Hospital
City
Shenyang
Country
China
Facility Name
The fourth hospital of Hebei Medical University
City
Shijia Zhuang
Country
China
Facility Name
The second hospital of Tianjin Medical University
City
Tianjing
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Facility Name
Hubei Provincial Cancer Hospital
City
Wuhan
Country
China
Facility Name
Tongji Hospital, Tongji medical college of HUST
City
Wuhan
Country
China
Facility Name
Union Hospital, Tongji Medical college of HUST
City
Wuhan
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
The Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
Country
China
Facility Name
Jiangsu Subei people's Hospital
City
Yangzhou
Country
China
Facility Name
Henan people's Hospital
City
Zhengzhou
Country
China
Facility Name
Henan Provincial Cancer Hospital
City
Zhengzhou
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Facility Name
RESEARCH SITE s.r.o.
City
Plzen
State/Province
Plzeň
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Pavlov
Country
Czechia
Facility Name
Nemocnice Na Homolce
City
Praha
Country
Czechia
Facility Name
Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
City
Ústí Nad Labem
Country
Czechia
Facility Name
Beskidzkie Centrum Onkologii im.Jana Pawla II
City
Bielsko-Biala
State/Province
Bielsko-Biała
Country
Poland
Facility Name
LexMedica Osrodek Badan Klinicznych
City
Wesoła
State/Province
Weigla
Country
Poland
Facility Name
KO-MED Centra Kliniczne Biala Podlaska
City
Biała Podlaska
Country
Poland
Facility Name
Swietokrzyskie Centrum Onkologii
City
Kielce
Country
Poland
Facility Name
Provita Profamilia
City
Piotrków Trybunalski
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. J. Korczaka
City
Słupsk
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36075260
Citation
Gu 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.
Results Reference
derived

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

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