Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate, previously untreated

- Potential candidate for radical prostatectomy on the basis of the patient's general
medical condition, performance status, and life expectancy

- Potential candidate for NHT prior to prostatectomy, including high or intermediate
risk of recurrence, based on an estimated risk of biochemical recurrence: High risk
category: PSA >20 or Gleason score 8 or cT2c/cT3 OR Intermediate risk category: PSA
>10 and d20 or Gleason score 7 or cT2b

- No evidence of metastatic disease by physical examination, bone scan, and computed
tomography, or MRI, of the abdomen and pelvis

- Age > 18 years

- ECOG performance status 0-1

- Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to
starting therapy

- Availability of prostatectomy specimen for histological analysis at the Armed Forces
Institute of Pathology

Exclusion Criteria:

- Prior hormone therapy, radiation, chemotherapy, or immunologic therapy for prostate
cancer

- History of, or significant risk for, chronic inflammatory or autoimmune disease

- Potential requirement for systemic corticosteroids before surgery based on prior
history

- History of autoimmune colitis or chronic GI conditions associated with diarrhea or
bleeding, or current acute colitis of any origin

- Any serious uncontrolled medical disorder or active infection which would impair
ability to receive study treatment and subsequent prostatectomy

- Coexisting malignancies except basal or squamous cell carcinoma of the skin