Sipuleucel-T as Neoadjuvant Treatment in Prostate Cancer

An Open Label, Phase 2 Trial of Immunotherapy With Sipuleucel-T (Provenge®) as Neoadjuvant Treatment in Men With Localized Prostate Cancer

This is an open label, Phase 2 trial of immunotherapy with sipuleucel-T as neoadjuvant treatment in men with localized prostate cancer.

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:

• 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:

• 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.