Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

Inclusion Criteria

• Histologically documented adenocarcinoma of the prostate
• Life expectancy of >= 6 months, Eastern Cooperative Oncology Group (ECOG) performance status = = 20% increase in the sum of the longest diameters of all measurable lesions or the development of any new lesions; the change will be measured against the best response to castration therapy or against the pre-castration measurements if there was no response
• Non-measurable disease:
• Soft tissue disease: The appearance of 1 or more lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response
• Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response; increased uptake of pre-existing lesions on bone scan does not constitute progression
• White blood cell (WBC) >= 2, 500 cells/uL
• Absolute neutrophil count (ANC) >= 1, 000 cells/uL
• Platelet count >= 75,000 cells/uL
• Hemoglobin (HgB) >= 9.0 g/dL
• Creatinine = 3 months before enrollment to the study

Exclusion Criteria

• The presence of liver, or known brain metastases, malignant pleural effusions, or malignant ascites
• Moderate or severe symptomatic metastatic disease, defined as a requirement for treatment with opioid analgesics for cancer-related pain within 21 days prior to registration
• Eastern Cooperative Oncology Group (ECOG) performance status > 2
• Treatment with chemotherapy within 3 months of registration
• Treatment with any of the following medications or interventions within 28 days of registration:
• Systematic corticosteroids; use of inhaled, intranasal, and topical steroids is acceptable
• Any other systemic therapy for prostate cancer (except for medical castration)
• History of external beam radiation therapy to metastatic sites within 1 year of enrollment to the study
• Participation in any previous study involving sipuleucel-T
• Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression
• Concurrent other malignancy with the exception of:
• Cutaneous squamous cell and basal carcinomas
• Adequately treated stage 1-2 malignancy
• Adequately treated stage 3-4 malignancy that has been in remission for >= 2 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 degrees Fahrenheit [F] or 38.1 degrees Celsius [C]) within 1 week prior to registration
• 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