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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
654

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Fakultni 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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