Phase II Trial of Radiation With Androgen Deprivation (AbiRAD): Abiraterone Acetate, Prednisone and LHRH Agonist Prior to and Concurrent With Radiation Therapy

Inclusion Criteria:

- Willing and able to provide written informed consent

- Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial
placement

- Written Authorization for Use and Release of Health and Research Study Information
has been obtained

- Histologically proven adenocarcinoma of the prostate

- Patients must be candidates for short or long term androgen deprivation in
combination with external beam radiotherapy (RT) based on the following criteria:

- Intermediate Risk Disease: T2b/c, or Gleason 7, or PSA 10-20

- High Risk Disease: Gleason 8-10, or PSA > 20, or T3/4

- Patients may not have received any prior pharmacologic therapy or RT for prostate
cancer

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- Karnofsky >= 60%

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the androgen axis will be determined following review of
their case by the Principal Investigator

- White blood cell count: >= 3,000/mm^3

- Absolute granulocyte count: >= 1,000/mm^3

- Platelets: >= 100,000/mm^3

- Hemoglobin >= 10g/dL

- Potassium >= 3.5 mmol/L

- Serum creatinine: =< 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) < 2.5 x ULN

- Alanine transaminase (ALT) < 2.5 x ULN

- Total bilirubin: =< 1.5 x ULN (except for patients with documented Gilbert's disease)

Exclusion Criteria:

- Patients may not be receiving any investigational agents

- Concurrent enrollment in another clinical investigational drug or device study is
prohibited

- The concurrent administration of other anticancer therapy, including cytotoxic or
hormonal agents (except LHRH agonists), or immunotherapy, is prohibited during
neoadjuvant concurrent and adjuvant therapy

- Patients who are currently receiving active therapy for other neoplastic disorders
will not be eligible

- Patients with histologic evidence of small cell carcinoma of the prostate will not be
eligible

- Patients with hypogonadism or severe androgen deficiency as defined by serum
testosterone less than 100 ng/dL will not be eligible

- History of pituitary or adrenal dysfunction

- Patients who are receiving any androgens, estrogens or progestational agents, or who
received any of these agents within the 6 months prior to evaluation will not be
eligible

- Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone,
ketoconazole, finasteride, dutasteride) will not be eligible

- Concomitant therapy with any of the following listed is prohibited: 5 alpha-reductase
inhibitor (finasteride, dutasteride); ketoconazole, diethylstilbestrol, PC-SPES, and
other preparations such as saw palmetto thought to have endocrine effects on prostate
cancer; radiopharmaceuticals such as strontium (89Sr) or samarium (153Sm); Aldactone,
Spironol (spironolactone); estrogens, testosterone, progesterones, herbal medications

- Patients who received any of these agents within the 6 months prior to evaluation
will be reviewed for eligibility by the Principal Investigator on a case by case
basis

- Use of other investigational drug therapy for any reason is prohibited

- Patients with inflammatory bowel disease or other autoimmune conditions which might
affect the radiated colon or rectum

- Patients with uncontrolled intercurrent illness including, but not limited to,
ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is
symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary
emboli, cerebrovascular accident or ischemia will not be eligible

- Patients who have chronic active hepatitis or acute hepatitis will not be eligible

- Patients with dementia/psychiatric illness/social situations that would limit
compliance with study requirements or would prohibit the understanding and/or giving
of informed consent will not be eligible

- Patients with medical conditions, which, in the opinion of the investigators, would
jeopardize either the patient or the integrity of the data obtained will not be
eligible

- Uncontrolled hypertension within the screening period (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 congestive heart failure of any severity

- Other active malignancy, except non-melanoma skin cancer and superficial bladder
cancer

- History of gastrointestinal disorders (medical disorders or extensive surgery) which
may interfere with the absorption of the study drug

- Patients with diabetes not controlled with diet alone (i.e. requiring insulin or oral
hypoglycemics)

- Patients unwilling to use contraceptives while on study