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

• Status: Active, not recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Bicalutamide; Hormones

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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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