Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

Inclusion Criteria:

Histologically documented adenocarcinoma of the prostate
Metastatic disease
Castrate resistant prostate cancer
Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
Life expectancy of ≥ 3 months
Men ≥ 18 years of age
Adequate hematologic, renal and liver function

Exclusion Criteria:

Presence of known lung, liver, or brain metastases
Evidence of neuroendocrine or small cell features
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
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 six months 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 > 100.5F or > 38.1C) 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

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 (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans
Non-steroidal anti-androgens (eg, 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
Chemotherapy
Treatment with any other investigational product