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

Inclusion Criteria:

• Age≧18 year, male;
• ECOG performance scale 0 to 1;
• Histologically or cytological confirmed prostate adenocarcinoma without neuroendocrinedifferentiation or small cell features ;
• Adequate hepatic, renal, heart, and hematological functions;
• Patients have given voluntary written informed consent before performance of anystudy-related procedure not part of normal medical care,with the understanding thatconsent may be withdrawn by the subject at any time without prejudice to futuremedical care.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 priorto day 1;
• Previous use or are using a second-generation androgen receptor antagonist (enzalutamide, ARN-509, ODM-201), abiraterone, ketoconazole for prostate cancer, orother agents that will inhibit the production of androgens;
• Have participated in an interventional clinical trial or been treated with thefollowing 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 avariety of other factors that affect drug use and absorption; Clinically significantcardiovascular 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.