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

• ClinicalTrials.gov Identifier: NCT03520478
• Recruitment Status: Active, not recruiting
• First Posted: May 9, 2018
• Last Update Posted: March 2, 2021
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Tracking Information

• First Submitted Date: April 27, 2018
• First Posted Date: May 9, 2018
• Last Update Posted Date: March 2, 2021
• Actual Study Start Date: May 30, 2018
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of SHR3680 in Treating Patients With Hormone Sensitive Prostate Cancer
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Prostate Cancer
• Hormone-Dependent Prostate Cancer

Intervention

• Drug: SHR3680
  Tablet. Specifications of 80 mg; orally, once a day
• Drug: Bicalutamide
  Tablet. Specifications of 50 mg; orally, once a day

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 28, 2021): 654
• Original Estimated Enrollment (submitted: April 27, 2018): 572
• Estimated Study Completion Date: April 30, 2025
• Estimated Primary Completion Date: April 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, China, Czechia, Poland

Administrative Information

• NCT Number: NCT03520478
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Dingwei Ye, M.D.; Fudan University

• PRS Account: Jiangsu HengRui Medicine Co., Ltd.
• Verification Date: February 2021