To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

Inclusion Criteria

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.

• Histologically documented adenocarcinoma of the prostate.
• Metastatic disease.
• Progressive androgen independent castrate resistant prostate cancer.
• Serum PSA ≥ 5.0 ng/mL.
• Life expectancy of ≥ 6 months.
• Castrate level of testosterone ( 0.5 mcg/day).
• Any other systemic therapy for prostate cancer (except for medical castration).
• Treatment with any investigational vaccine within 2 years of registration or treatment with any other investigational product within 28 days of registration.
• Participation in any previous study involving sipuleucel-T, regardless of whether the subject received sipuleucel-T (APC8015) or placebo.
• Known pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.
• A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ≥ 3 years at the time of registration.
• A requirement for systemic immunosuppressive therapy for any reason.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or granulocyte-macrophage colony-stimulating factor.
• Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5°F or > 38.1°C) within 1 week prior to registration.
• Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.