Prostate Cancer Study Decision Tree

Inclusion Criteria

• 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

• 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 (eg, antitumor necrosis factor alpha monoclonal antibodies, or glucocorticoids)
• 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