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).
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.
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
