A Phase 1, Open Label, Non-Randomized, Dose Escalation Study to Evaluate the Safety of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and a Phase 2, Open Label, Randomized Study to Evaluate the Efficacy of CP-675,206 in Combination With Neoadjuvant Androgen Ablation and Androgen Ablation Alone in Patients With High Risk Prostate Cancer

Study start date: March 1, 2004

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