A Phase 2 Study of Bicalutamide Plus Finasteride in Men With MRI Detectable Prostate Nodules Undergoing Active Surveillance

Exclusion Criteria

• •1. Prior local therapy to treat prostate cancer (e.g., radical prostatectomy, radiation therapy, brachytherapy)
• •2. Prior use of bicalutamide
• •3. Prior use of finasteride within the past year
• •4. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
• •* Hormonal therapy (e.g., leuprolide, goserelin, triptorelin)
• •* CYP-17 inhibitors (e.g., abiraterone, ketoconazole)
• •* Antiandrogens (e.g., bicalutamide, flutamide, nilutamide)
• •* Second generation antiandrogens (e.g., enzalutamide, ARN-509)
• •* Immunotherapy (e.g., sipuleucel-T, ipilimumab)
• •* Chemotherapy (e.g., docetaxel, cabazitaxel)
• •5. Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study.
• •6. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
• •7. Abnormal bone marrow function \[absolute neutrophil count (ANC)\<1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL\]
• •8. Abnormal liver function (bilirubin, AST, ALT ≥ 3 x upper limit of normal)
• •9. Abnormal kidney function (serum creatinine ≥ 2 x upper limit of normal)
• •10. Abnormal cardiac function as manifested by NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study.