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UNKNOWNPHASE3

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

A Phase III, Multicenter, Randomized, Open Study of SHR3680 Compared to Bicalutamide in the Treatment of Patients With Hormone Sensitive Prostate Cancer

NCT03520478•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

Locations (67)

Complex oncological center - Bourgas

Burgas, Bulgaria

UMHAT 'Deva Maria'. EOOD

Burgas, Bulgaria

MHAT - Dobrich. AD

Dobrich, Bulgaria

MHAT 'Dr. Tota Venkova'. AD

Gabrovo, Bulgaria

Complex Oncological Center - Plovdiv. EOOD

Plovdiv, Bulgaria

MHAT 'Central Onco Hospital'. OOD

Plovdiv, Bulgaria

Acibadem City Clinic Tokuda Hospital Ead

Sofia, Bulgaria

Affiliated Hospital of Hebei University

Baoding, China

Beijing Cancer Hospital

Beijing, China

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

May 30, 2018

Primary Completion Date

April 30, 2023

Completion Date

April 30, 2025

Last Updated

March 2, 2021

Enrollment

654

ACTUAL participants

Conditions

Prostate CancerHormone-Dependent Prostate Cancer

Interventions

SHR3680

DRUG

Bicalutamide

DRUG

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC