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

Inclusion Criteria:

1. Age≧18 year, male;
2. ECOG performance scale 0 to 1;
3. Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ;
4. Adequate hepatic, renal, heart, and hematological functions;
5. 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performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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:

1. 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;
2. 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;
3. 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 ;
4. Evidence of brain metastasis or primary tumors;
5. Planned to initiate any other anti-tumor therapies during the study;
6. 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;
7. History of seizure or certain conditions that may predispose to seizure;
8. Severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.