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

Inclusion Criteria:

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

1. Potential subjects are men aged ≥18 years who are clinically indicated for treatmentwith PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant [hormone refractory] prostate cancer).

2. Have qualified for on-label PROVENGE® infusion

3. Have received all 3 infusions of PROVENGE® prior to randomization

4. Written informed consent provided prior to the initiation of study procedures

5. 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.

1. Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic orminimally symptomatic metastatic castrate-resistant [hormone refractory] prostatecancer).

2. Need for systemic chronic immunosuppressive therapy, including antitumor necrosisfactor alpha monoclonal antibodies, glucocorticoids, systemic steroids, bloodproducts, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations,or experimental and investigational therapies (see Section 6.3.1)

3. Uncontrolled, concurrent illness, including, but not limited to the following:ongoing or active infection (bacterial, viral, or fungal), or psychiatric illnessthat would limit compliance with study requirements, as well as any condition thatwould preclude a subject from completing PROVENGE® or sipuleucel-T treatment.

4. On experimental or investigational therapy.