A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

Exclusion Criteria

• •1. Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy, brachytherapy)
• •2. Prior therapy to a metastatic site.
• •3. Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
• •1. Hormonal therapy (e.g. leuprolide, goserelin, triptorelin, degarelix)
• •2. CYP-17 (cytochrome P450 17α-hydroxy/17,20-lyase) inhibitors (e.g. ketoconazole)
• •3. Antiandrogens (e.g. bicalutamide, nilutamide)
• •4. Second generation antiandrogens (e.g. enzalutamide, abiraterone)
• •5. Immunotherapy (e.g. sipuleucel-T, ipilimumab)
• •6. Chemotherapy (e.g. docetaxel, cabazitaxel) \*Note: may be enrolled if hormone therapy was recently initiated (\<90 days duration)). In the event that hormone therapy was initiated prior to study enrollment, the clock for 2 years of androgen deprivation would begin at the time of therapy initiation, rather than at study enrollment.
• •4. 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.
• •5. Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule.
• •6. Abnormal bone marrow function \[absolute neutrophil count (ANC)\<1500/mm3, platelet count \<100,000/mm3, hemoglobin \<9 g/dL\]
• •7. Abnormal liver function (bilirubin \>ULN ( upper limit of normal); AST (aspartate aminotransferase), ALT (alanine transaminase) \> 2.5 x upper limit of normal)
• •8. Creatinine clearance of ≥ 30 mL/min. CrCl (Creatinine clearance) should be calculated suing the Cockcroft-Gault formula.
• •9. Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within previous six months.
• •10. Prior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin. Other malignancies that are considered to have a low potential to progress may be enrolled at discretion of PI.