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

February 28, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

654

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria
        • Complex oncological center - Bourgas
      • Burgas, Bulgaria
        • UMHAT 'Deva Maria'. EOOD
      • Dobrich, Bulgaria
        • MHAT - Dobrich. AD
      • Gabrovo, Bulgaria
        • MHAT 'Dr. Tota Venkova'. AD
      • Plovdiv, Bulgaria
        • Complex Oncological Center - Plovdiv. EOOD
      • Plovdiv, Bulgaria
        • MHAT 'Central Onco Hospital'. OOD
      • Sofia, Bulgaria
        • Acibadem City Clinic Tokuda Hospital Ead
  • China
      • Baoding, China
        • Affiliated Hospital of Hebei University
      • Beijing, China
        • Tumor Hospital of the Chinese Academy of Medical Sciences
      • Beijing, 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
      • Changchun, China
        • The First Hospital of Jilin University
      • Changchun, China
        • China Japan Friendship Hospital of Jilin University
      • Changsha, China
        • Hunan Cancer hospital
      • Chengdu, China
        • West China Hospital of Sichuan University
      • Chongqing, China
        • Chongqing Cancer Hospital
      • Chongqing, China
        • Army characteristic medical center of the Chinese people's Liberation Army
      • Chongqing, China
        • The First Affiliated Hospital of Army Medical University
      • Fuzhou, China
        • The First Affiliated Hospital of Fujian Medical University
      • Guangzhou, China
        • Sun Yat-Sen University Cancer Center
      • Guangzhou, China
        • Sun Yat-Sen hospital of Sun Yat-Sen University
      • Hangzhou, China
        • Zhejiang Cancer Hospital
      • Hangzhou, China
        • The First Affiliated Hospital of Zhejiang University Medicine college
      • Hangzhou, China
        • The Second Affiliated Hospital of Zhejiang University Medical College
      • Hangzhou, China
        • Zhejiang Province People's Hospital
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, China
        • Anhui Provincial Hospital
      • Jinan, China
        • Qilu Hospital of Shandong University
      • Kunming, China
        • Yunnan Provincial Cancer Hospital
      • Lanzhou, China
        • The Second Hospital of Lanzhou University
      • Nanchang, China
        • The First Affiliated Hospital of NanChang University
      • Nanjing, China
        • Gulou Hospital Affiliated to Medical College of Nanjing University
      • Nanjing, China
        • Jiangsu Provincial Cancer Hospital
      • Nanjing, China
        • Jiangsu Provincial People's Hospital
      • Shanghai, China
        • Shanghai General Hospital
      • Shanghai, China
        • Ruijin Hospital
      • Shanghai, China
        • Huadong Hospital of Fudan University
      • Shanghai, China
        • The Cancer Hospital of Fudan University
      • Shanghai, China
        • Zhongshan Hospital of Fudan University
      • Shenyang, China
        • Liaoning Provincial Cancer Hospital
      • Shijia Zhuang, China
        • The Fourth Hospital of Hebei Medical University
      • Tianjing, China
        • The Second Hospital of Tianjin Medical University
      • Wenzhou, China
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China
        • Tongji Hospital, Tongji Medical College of HUST
      • Wuhan, China
        • Hubei Provincial Cancer Hospital
      • Wuhan, China
        • Union Hospital, Tongji Medical College of HUST
      • Wuxi, China
        • Wuxi People's Hospital
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, China
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
      • Yangzhou, China
        • Jiangsu Subei People's Hospital
      • Zhengzhou, China
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, China
        • Henan People's Hospital
      • Zhengzhou, China
        • Henan Provincial Cancer Hospital
  • Czechia
      • Brno, Czechia
        • Fakultni nemocnice u sv. Anny v Brne
      • Pavlov, Czechia
        • Fakultní nemocnice Olomouc
      • Praha, Czechia
        • Nemocnice na Homolce
      • Ústí Nad Labem, Czechia
        • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
    • Plzeň
      • Plzen, Plzeň, Czechia
        • Research Site s.r.o.
  • Poland
      • Biała Podlaska, Poland
        • KO-MED Centra Kliniczne Biala Podlaska
      • Kielce, Poland
        • Swietokrzyskie Centrum Onkologii
      • Piotrków Trybunalski, Poland
        • Provita Profamilia
      • Słupsk, Poland
        • Wojewodzki Szpital Specjalistyczny im. J. Korczaka
    • Bielsko-Biała
      • Bielsko-Biala, Bielsko-Biała, Poland
        • Beskidzkie Centrum Onkologii Im.Jana Pawla Ii
    • Weigla
      • Wesoła, Weigla, Poland
        • LexMedica Osrodek Badan Klinicznych

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR3680
Participants will receive SHR3680 orally
Drug: SHR3680
Tablet. Specifications of 80 mg; orally, once a day
Active Comparator: bicalutamide
Participants will receive bicalutamide orally
Drug: Bicalutamide
Tablet. Specifications of 50 mg; orally, once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rPFS
Time Frame: Approximately 70 months
Time from randomisation to radiologically confirmed progressive disease or death due to any cause
Approximately 70 months
OS
Time Frame: Approximately 70 months
Time from randomisation to death due to any cause
Approximately 70 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to prostate specific antigen (PSA) progression
Time Frame: Approximately 70 months
Time from randomisation to the first time of PSA progression according to the criterion of PCGW3
Approximately 70 months
Time to skeletal-related events
Time Frame: Approximately 70 months
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
Objective response rate (ORR)
Time Frame: Approximately 70 months
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
Time to initiation of a new antineoplastic therapy
Time Frame: Approximately 70 months
Time from randomisation to the initiation of antineoplastic subsequent to the study treatment
Approximately 70 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

April 27, 2018

First Submitted That Met QC Criteria

April 27, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 28, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-3680-III-HSPC

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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