Overview
Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).
Description
This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.
Eligibility
Inclusion Criteria:
- Men ≥ 18 years of age
- Prostate cancer with history of metastasis
- Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of ≥ 6 months
Exclusion Criteria:
- Previously received Sipuleucel-T (Provenge®)
- Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
- A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent)
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
- Any infection requiring antibiotic therapy within 1 week prior to registration