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

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.

Sex

Male

Minimum age

18 Years

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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

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• DERIVEDWang H, Jiang S, 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, Chen J, Dong Q, Zhang X, Li H, Yang X, Lian J, Wang W, Ye D. Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study. Signal Transduct Target Ther. 2024 Dec 18;9(1):351. doi: 10.1038/s41392-024-02064-z. PMID 39690158
• DERIVEDBian X, Gu W, Zhang X, Xie L, Wang S, Shi B, Sun T, Wei S, Weng Z, Xia S, Han B, Xu Z, Xing J, Zhang D, Xu D, Du C, He C, Wang Q, Yang X, Lian J, Wang W, Ye D. Correlation of PSA and survival in metastatic hormone-sensitive prostate cancer treated with rezvilutamide plus ADT in the CHART trial. Med. 2025 Feb 14;6(2):100520. doi: 10.1016/j.medj.2024.09.009. Epub 2024 Oct 16. PMID 39419035
• DERIVEDGu 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. PMID 36075260