Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Bone Metastases; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Soft Tissue Metastases; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Intervention: sipuleucel-T; external beam radiation therapy; laboratory biomarker analysis
Intervention description: Given IV; Undergo external beam radiation therapy; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well giving sipuleucel-T with or without radiation
      therapy works in treating patients with hormone-resistant metastatic prostate cancer.
      Vaccines may help the body build an effective immune response to kill tumor cells. Radiation
      therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving
      sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented adenocarcinoma of the prostate

          -  Life expectancy of >= 6 months, Eastern Cooperative Oncology Group (ECOG) performance
             status =< 2

          -  Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone
             scan and/or computed tomography (CT) scan or magnetic resonance imaging (MRI) of the
             abdomen or pelvis

          -  Castration resistant prostatic adenocarcinoma; subjects must have current or
             historical evidence of disease progression despite castrated level of testosterone (<
             50 ng/dL) achieved by orchiectomy or luteinizing hormone-releasing hormone (LHRH)
             agonist or antagonist therapy; disease progression has to be demonstrated by PSA
             progression OR progression of measurable disease OR progression of non-measurable
             disease as defined below:

               -  PSA: Two consecutive rising PSA values, at least 7 days apart

               -  Measurable disease: >= 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 =< 2.5 mg/dL

          -  Total bilirubin =< 2 x institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) and
             alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x
             institutional ULN

          -  Prior chemotherapy with 0-2 regimens is allowed

          -  Prior radiation therapy to prostate or prostate bed is allowed provided it occurred >
             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