This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: Investigational Drug + neoadjuvant hormone therapy (NHT) OR Arm B: neoadjuvant hormone therapy. After randomization, patients will receive study treatment for three cycles (one cycle is defined as 28 days). After completion of three cycles, patients will undergo a prostatectomy and pathology assessments will be completed at a central laboratory, the Armed Forces Institute of Pathology (AFIP) in Washington, DC. Up to 52 response evaluable patients are expected to be enrolled in this study.

Condition	Treatment or Intervention	Phase
Prostate Cancer	Drug: Investigational New Drug	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion:

• 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:

• 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

Dr. Jesus Gomez-Navarro, MD      860-732-2079    jesus_gomez-navarro@groton.pfizer.com

California
      Pfizer Investigational Site, San Diego,  California,  92134,  United States; Recruiting
District of Columbia
      Pfizer Investigational Site, Washington,  District of Columbia,  20307,  United States; Recruiting
Rhode Island
      Pfizer Investigational Site, Providence,  Rhode Island,  02903,  United States; Recruiting
      Pfizer Investigational Site, Providence,  Rhode Island,  02904,  United States; Recruiting
      Pfizer Investigational Site, Providence,  Rhode Island,  02905,  United States; Recruiting
Tennessee
      Pfizer Investigational Site, Nashville,  Tennessee,  37203,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37203,  United States; Recruiting
      Pfizer Investigational Site, Smyrna,  Tennessee,  37167,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37203,  United States; Recruiting
      Pfizer Investigational Site, Gallatin,  Tennessee,  37066,  United States; Recruiting
      Pfizer Investigational Site, Lebanon,  Tennessee,  37087,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37207,  United States; Recruiting
      Pfizer Investigational Site, Hermitage,  Tennessee,  37076,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37205,  United States; Recruiting
      Pfizer Investigational Site, Murfreesboro,  Tennessee,  37130,  United States; Recruiting
      Pfizer Investigational Site, Nashville,  Tennessee,  37211,  United States; Recruiting
Washington
      Pfizer Investigational Site, Tacoma,  Washington,  98431,  United States; Recruiting

Study ID Numbers:  A3671004
Record last reviewed:  November 2004
Record first received:  January 5, 2004
ClinicalTrials.gov Identifier:  NCT00075192
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10