AASUR in High Risk Prostate Cancer

Inclusion Criteria

• Histological or cytologic evidence of adenocarcinoma of the prostate confirmed at local institution.
• At least one of the following:
• Two or more high risk features OR
• Gleason score 8-10
• PSA ≥20 ng/mL within two months prior to registration
• Clinical Stage ≥T3 disease, as determined by standard digital rectal examination (DRE)
• Radiographic stage ≥T3 disease as determined by a ≥75% probability of extracapsular extension or seminal vesicle invasion per reading radiologist
• Any Gleason 9 or 10 disease OR >4 cores of Gleason 8 disease
• KPS ≥ 70%
• IPSS (International Prostate Symptom Score) ≤ 20F
• Patient must be available for follow-up
• Laboratory test findings within 28 days of study registration :
• Adequate hepatic function:
• Bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN). Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is 1.5 x the institutional ULN, direct and indirect bilirubin will be measured and if direct bilirubin is ≤ 1.5 x the institutional ULN, the patient will be eligible to participate
• SGPT (ALT) and SGOT (AST) ≤ 2.5 x ULN
• Adequate renal function with creatinine 1.5 cm on the short axis will require review by the local reference radiologist per institutional RECIST review practices. If the lymph nodes are considered suspicious on repeat review, they must be confirmed negative for study participation
• Prior treatment for prostate cancer; this includes any prior surgery (including Transurethral resection of the prostate (TURP), prostate cancer treatment), chemotherapy, radiation, or anti-androgen therapy/androgen deprivation therapy with the following exception: patients who will have been on LHRH Agonist/Antagonist Therapy for 450ms at the Screening Visit
• Uncontrolled diabetes, heart disease, hypertension
• Gastrointestinal disorder that may affect absorption of study treatment
• Active symptomatic viral hepatitis or chronic liver disease
• History of pituitary or adrenal dysfunction
• Active Infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone corticosteroid) use contraindicated
• Patients with Crohn's disease or ulcerative colitis
• Patients that cannot tolerate MRI
• Inability to have fiducial markers placed
• Any condition that in the opinion of the investigator, would preclude participation in this study
• Enrollment concurrently in another investigational drug study or within 4 weeks of registration
• Concurrent treatment with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)