Sipuleucel-T is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer.

Sipuleucel-T consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.

The study will evaluate the safety of and magnitude of the immune responses to treatment with sipuleucel-T.

Study Requirements

Subjects will receive the investigational product, sipuleucel-T, at approximately two week intervals, for a total of three infusions.

All subjects will be followed for 30 days following the last infusion of sipuleucel-T. The study is also available to placebo subjects who participated in the D9902B study.

Eligibility 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
• Castrate-resistant prostate cancer
• Serum PSA >= 5.0 ng/mL
• Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration
• Life expectancy of at least three months
• Men at least 18 years old
• Adequate hematologic, renal, and liver function

Exclusion Criteria

A subject will not be eligible for participation in this study if any of the following criteria apply.

• The presence of known lung, liver, or brain metastases
• Evidence of neuroendocrine or small cell features
• Eastern Cooperative Oncology Group (ECOG) performance status greater than two
• Prior treatment with three infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)
• Imminent pathologic long-bone fracture (cortical erosion on radiography is greater than 50 percent) 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 GM-CSF
• Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5F or > 38.1C) within one 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, ≤ one 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

Compensation

Participants will receive no payment for participation, ideas, or products that may result from this study.

For more information, contact Karla Morris at 919-668-8375.