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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.

Tracking Information
First Submitted Date  ICMJE April 27, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE May 30, 2018
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • rPFS [ Time Frame: Approximately 70 months ]
    Time from randomisation to radiologically confirmed progressive disease or death due to any cause
  • OS [ Time Frame: Approximately 70 months ]
    Time from randomisation to death due to any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
Official Title  ICMJE A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Prostate Cancer
  • Hormone-Dependent Prostate Cancer
Intervention  ICMJE
  • Drug: SHR3680
    Tablet. Specifications of 80 mg; orally, once a day
  • Drug: Bicalutamide
    Tablet. Specifications of 50 mg; orally, once a day
Study Arms  ICMJE
  • Experimental: SHR3680
    Participants will receive SHR3680 orally
    Intervention: Drug: SHR3680
  • Active Comparator: bicalutamide
    Participants will receive bicalutamide orally
    Intervention: Drug: Bicalutamide
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 28, 2021)
654
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
572
Estimated Study Completion Date  ICMJE April 30, 2025
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   China,   Czechia,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520478
Other Study ID Numbers  ICMJE SHR-3680-III-HSPC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dingwei Ye, M.D. Fudan University
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP