Sipuleucel-T Manufacturing Demonstration Study

Inclusion Criteria: * Histologically documented adenocarcinoma of the prostate * Metastatic disease as evidenced by soft tissue and/or bony metastases on bone scan and/or computed tomography (CT) scan of the abdomen and pelvis at any time prior to registration * Castrate resistant prostate cancer * Serum PSA ≤ 5.0 ng/mL * Castration levels of testosterone (≤ 50 ng/dL; ≤ 1.74 nmol/L) achieved via medical or surgical castration. Surgical castration must have occurred at least 3 months prior to registration. * ECOG performance status ≤ 1 * Adequate hematologic, renal, and liver function * Negative serology tests indicating no active infection with human immunodeficiency virus types 1 and 2 (HIV-1/2), human T cell lymphotropic virus types 1 and 2 (HTLV-I/II), and Hepatitis B and C viruses. 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.