Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

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