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

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ClinicalTrials.gov Identifier: NCT03520478
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 572 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


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




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



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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.

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


Contacts
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Contact: Chunlei Jin, Ph.D. 86-021-23511999 jinchunlei@shhrp.com

Locations
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China
Ye Dingwei Recruiting
Shanghai, China
Contact: Dingwei Ye, Doctor         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Dingwei Ye, M.D. Fudan University

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03520478     History of Changes
Other Study ID Numbers: SHR-3680-III-HSPC
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: April 2018

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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:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Immune System Diseases
Hormones
Bicalutamide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents