Abiraterone Acetate, Radiation Therapy, and Hormone Therapy in Treating Patients with Unfavorable-Risk Localized Prostate Cancer

Inclusion Criteria

• Adenocarcinoma of the prostate proven by biopsy within 180 days of study registration with one of the following high risk criteria: * Gleason score 7 with PSA =< 20 ng/ml and clinical T1-2, or * Gleason score 8-10, PSA =< 20 ng/ml and clinical T1-2, or * PSA 10.1-40 ng/ml with Gleason score (GS) < 7 and clinical T1-2, or * Clinical T3 with Gleason score < 7 and PSA =< 10 ng/ml
• Eastern Cooperative Oncology Group (ECOG) performance status =< 1
• Digital rectal exam within 90 days of registration on study
• Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 30 days prior to registration on study)
• Platelets > 100,000/uL (within 30 days prior to registration on study)
• Hemoglobin >= 9 g/dL (within 30 days prior to registration on study)
• Serum potassium >= 3.5 mEq/L (within 30 days prior to registration on study) * Hypokalemia can be managed and corrected at the physician’s discretion; patients who have hypokalemia must have a repeat serum potassium level drawn within 7 days before starting study drug; patients with a supported potassium level at >= 3.5 can be considered eligible at the physician’s discretion
• Serum albumin >= 3.0 g/dl (within 30 days prior to registration on study)
• Total bilirubin < 1.5 x of institutional upper limit of normal (ULN) (within 30 days prior to registration on study)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 1.5 x ULN (within 30 days prior to registration on study)
• Calculated creatinine clearance > 60 mL/min (within 30 days prior to registration on study)
• Able to swallow a whole tablet and take abiraterone acetate on an empty stomach (defined as no food for two hours before and one hour after abiraterone acetate ingestion)
• Ability to understand and sign a written informed consent document
• Written authorization for use and release of health and research study information has been obtained
• Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
• Subjects who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protections as determined acceptable by the principal investigator during the study and for 1 week after the last dose of abiraterone acetate

Exclusion Criteria

• Evidence of bone, brain, visceral or soft tissue metastasis, including lymph nodes on pelvic computed tomography (CT) (>= 2 cm in longest diameter)
• Prior therapy for prostate cancer (exceptions: luteinizing hormone-releasing hormone [LHRH] agonist or antagonist may have been initiated within 30 days prior to enrollment; bicalutamide may have been given within 60 days of enrollment as long as it has been stopped at least 7 days before enrollment and total duration was no longer than 30 days; previous alpha-reductase inhibitor use allowed IF patient has not been taking for at least 30 days prior to abiraterone acetate initiation, OR if alpha reductase inhibitor was not used as a primary treatment of prostate cancer and the PSA on alpha-reductase inhibitor remains within eligibility when doubled
• Known serum testosterone =< 150 ng/dl or symptoms of hypogonadism (fatigue, hot flashes, hair loss, loss of muscle mass, osteoporosis, low libido, depression) prior to ADT initiation not explained by other medical co-morbidity OR history of testosterone supplement; if questionable, serum testosterone level greater than 150 ng/dl can be used to exclude hypogonadism
• Previous malignancy within 3 years other than non-melanomatous skin cancer and non-muscle invasive bladder cancer
• Previous pelvic radiotherapy that would prevent prostate/seminal vesicle (SV) irradiation
• Receiving any investigational agents currently or within 30 days prior to study screening
• Prior demonstrated hypersensitivity, intolerance or allergy to abiraterone acetate, prednisone or their excipients
• Uncontrolled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
• History of gastrointestinal disorders that may interfere with the absorption of study drug (including gastric bypass surgery)
• Active co-morbidity, defined as follows: * Chronic liver disease with cirrhosis (Child-Pugh B or C) or active hepatitis B or C * History of pituitary or adrenal dysfunction * Poorly controlled diabetes mellitus (A1c > 9% or history of complications including peripheral neuropathy, end organ damage, hospitalization, amputation) * Poorly controlled glaucoma * Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class III-IV heart disease or known cardiac ejection fraction measurement of < 50% at baseline * Clinical evidence of active infection of any type, including active or symptomatic viral hepatitis * Known immune deficiency and/or human immunodeficiency virus (HIV)-positive patients * Any medical condition that warrants long-term corticosteroid use in excess of study dose
• Concurrent spironolactone use
• Patients taking strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital)
• Significant concurrent medical condition that would make prednisone/prednisolone use contraindicated or would interfere with the patient’s ability to participate in the trial
• Any condition that in the opinion of the principal investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirements