Sipuleucel-T Manufacturing Demonstration Study

Exclusion Criteria

• •The presence of known brain metastases
• •A requirement for systemic immunosuppressive therapy for any reason
• •Treatment with any investigational vaccine within 2 years prior to registration
• •Any previous treatment with sipuleucel-T
• •Any previous treatment with ipilimumab (Yervoy\[TM\], MDX-010, or MDX-101) or denosumab (Xgeva\[TM\])
• •Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%), or spinal cord compression
• •Known malignancies other than prostate cancer that are likely to require treatment within 6 months of registration
• •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
• •More than 2 chemotherapy regimens at any time prior to registration
• •Treatment with any chemotherapy within 90 days of registration
• •Received granulocyte colony-stimulating factor (G-CSF) or GM-CSF within 90 days prior to registration
• •Treatment with any of the following medications or interventions within 28 days of registration:
• •Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (i.e., ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans.
• •Non-steroidal anti-androgens (e.g., bicalutamide, flutamide, or nilutamide)
• •External beam radiation therapy or major surgery requiring general anesthetic
• •Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary.
• •Immunosuppressive therapy
• •Treatment with any other investigational product
• •Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 7 days prior to registration.
• •Any medical intervention or other condition which, in the opinion of the Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.