• To assess the immune response within prostate tissue following neoadjuvant treatment with sipuleucel T. [ Time Frame: baseline and at prostatectomy ] [ Designated as safety issue: No ]
  

• Other immunological or immunohistochemical tests will be evaluated [ Time Frame: estimated ] [ Designated as safety issue: No ]
  

Biological: Sipuleucel-T
Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

This is a single center, open label, Phase 2 study. Subjects will be treated with 3 infusions of sipuleucel-T prior to a scheduled radical prostatectomy (RP) surgery. To assess the immune response following treatment with sipuleucel-T, tissue from the prostatectomy specimen will be compared with tissue from the core biopsy specimen obtained prior to treatment with sipuleucel T. Following RP, subjects will be randomized to receive either a booster infusion of sipuleucel T or no further treatment with sipuleucel-T (i.e., booster: no booster).

Inclusion Criteria

Eligible subjects must meet all of the following criteria.

• Adenocarcinoma of the prostate.
• Subject is scheduled for RP as the initial therapy for localized prostate cancer.
• Subject is ≥ 18 years of age.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subject has adequate hematologic, renal, and liver function.

Exclusion Criteria

A subject is not eligible for study participation if any of the following criteria apply.

• Subject has any evidence of metastasis.
• Subject received hormones, including luteinizing hormone-releasing hormone agonists, antiandrogens, or 5 α-reductase inhibitors at any time prior to study screening.
• Subject has received prior radiation therapy or chemotherapy for prostate cancer.
• Subject has received systemic steroid therapy within 14 days.
• Subject has a history of stage III or greater cancer, excluding prostate cancer. Subjects with a history of basal or squamous cell skin cancers are allowed, provided that the subject was adequately treated and is disease-free at the time of study screening. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years prior to study screening.