Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.

Inclusion criteria

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:

• Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
• Have qualified for on-label PROVENGE® infusion
• Have received all 3 infusions of PROVENGE® prior to randomization
• Written informed consent provided prior to the initiation of study procedures
• Estimated life expectancy ≥12 months

Exclusion criteria

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

• Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).
• Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
• Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
• On experimental or investigational therapy.