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

Inclusion Criteria

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.