A clinical study on SHR3680 combined with androgen deprived therapy (ADT) versus Bicalutamide combined with ADT in treatment of prostate cancer

Prior treatment

• Previous ADT, chemotherapy, surgery, external irradiation, brachytherapy, radiopharmaceuticals or experimental local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.), with some exceptions.
• Previous use or plan to use the 2nd generation androgen receptor antagonist (e.g., enzalutamide, ARN-509, ODM-201), ketoconazole, Abiraterone Acetate or other drugs under development inhibiting androgen synthesis (e.g., TAK-700) during study treatment for treatment of prostate cancer.
• The subjects have received the following therapies within 4 weeks prior to C1D1:  5α-reductase inhibitor (e.g., Finasteride, dutasteride, etc.);  Estrogen, progesterone, androgen, steroid systemic therapy (except the temporary use for anti-allergic purpose);  Plant medicine with known anti-prostate cancer or PSA-lowering effect (e.g., Saw Palmetto);  Study treatment in other clinical trials.
• Plan to receive any other antitumor therapies during this trial.

Other

• Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.

• Age ≥ 18 years, male
• Performance status ECOG Scores 0-1;
• Histologically or cytologically confirmed adenocarcinoma of the prostate, and no neuroendocrine differentiation or small cell characteristics indicated;
• High tumor load, i.e., the radiological examination meets at least one of the following conditions: 1) ≧4 bone metastatic foci in Tc-99m bone scanning (at least one focus not located in pelvis or spine); 2) visceral metastasis shown on CT/MRI (not including lymph nodes);
• Plan to receive or maintain ADT during the study, i.e., to receive luteinizing hormone releasing hormone analogue (LHRHA) for continuous treatment (medical castration) or previous bilateral orchidectomy (surgical castration);