Inclusion Criteria
Histologically documented adenocarcinoma of the prostate
Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan of the chest, abdomen, and pelvis
Androgen independent prostatic adenocarcinoma. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
Adequate hematologic, renal, and liver function
Exclusion Criteria
The presence of lung, liver, or known brain metastases, malignant pleural ffusions, or malignant ascites
Moderate or severe symptomatic metastatic disease
A requirement for treatment with opioid analgesics for any reason within 28 days prior to registration
Average weekly pain score of 4 or more as reported on the 10-point Visual Analog Scale (VAS) on the Registration Pain Log
Eastern Cooperative Oncology Group (ECOG) performance status > 2
Use of non-steroidal antiandrogens (e.g., flutamide, nilutamide, or bicalutamide) within 6 weeks of registration
Treatment with chemotherapy within 28 days of registration including subjects who received more than 2 chemotherapy regimens in the metastatic setting at any time prior to registration
Treatment with any of the following medications or interventions within 28 days of registration:
Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
Ketoconazole
High dose calcitriol [1,25(OH)2VitD] (i.e., > 7.0 ?g/week)
Any other systemic therapy for prostate cancer (except for medical castration)
Prior treatment with sipuleucel-T (on clinical trial or as part of standard of care)
Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
Paget's disease of bone
A history of stage III or greater cancer, excluding prostate cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer must have been adequately treated and been disease-free for ? 3 years at the time of registration
A requirement for systemic immunosuppressive therapy for any reason
Any infection requiring parenteral antibiotic therapy or causing fever (temperature > 100.5?F or 38.1?C) within 1 week prior to registration
A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT imaging
Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives