This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520478
Recruitment Status : Active, not recruiting
First Posted : May 9, 2018
Last Update Posted : March 2, 2021
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Hormone-Dependent Prostate Cancer Drug: SHR3680 Drug: Bicalutamide Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 654 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. rPFS [ Time Frame: Approximately 70 months ]
    Time from randomisation to radiologically confirmed progressive disease or death due to any cause

  2. OS [ Time Frame: Approximately 70 months ]
    Time from randomisation to death due to any cause


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520478


Locations
Show Show 67 study locations
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Dingwei Ye, M.D. Fudan University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03520478    
Other Study ID Numbers: SHR-3680-III-HSPC
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021

Layout table for additional information
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
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
Hormone sensitive prostate cancer
SHR3680
Anti-androgen receptor
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
 Prostatic Diseases
Male Urogenital Diseases
Immune System Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents