Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.

Inclusion Criteria:

• Histologically documented adenocarcinoma of the prostate
• Metastatic disease as evidenced by soft tissue and/or bony metastases
• Prostate-specific antigen value of at least 5 ng/mL
• Tumor progression while on hormonal therapy
• Castration levels of testosterone (defined as less than 50 ng/dL)
• Life expectancy of at least 16 weeks
• Adequate hematologic, renal, and liver function

Exclusion Criteria:

• Visceral organ metastases
• Metastatic disease expected to be in need of radiation therapy within 4 months.
• Concurrent therapy with experimental agents