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

 I. To assess the feasibility, based on percent able or willing to receive all three infusions
 of sipuleucel-T immunotherapy, when combining sipuleucel-T with radiation therapy to a single
 site of metastasis delivered one week prior to beginning of sipuleucel-T therapy.

 SECONDARY OBJECTIVES:

 I. To assess the effect of radiation therapy to single metastasis on immune response
 (antibody and T-cell proliferation to prostate acid phosphate [PAP] and fusion protein
 PA2024) generated by sipuleucel-T immunotherapy.

 II. To assess the effect of external beam radiotherapy to single metastasis on prostate
 specific antigen (PSA) response to therapy with sipuleucel-T.

 III. To assess the effect of external beam radiotherapy to single metastasis on radiographic
 response rate to therapy with sipuleucel-T.

 IV. To assess the time from the onset of therapy with sipuleucel-T +/- radiation to the need
 for subsequent therapy for prostate cancer.

 V. To assess the toxicity associated with sipuleucel-T +/- radiation.

 OUTLINE: Patients are randomized to 1 of 2 treatment arms.

 ARM A: Patients receive sipuleucel-T intravenously (IV) over 60 minutes days 22, 36, and 50.

 ARM B: Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive
 sipuleucel-T as in Arm A.

 In both arms, treatment continues in the absence of disease progression or unacceptable
 toxicity.

 After completion of study treatment, patients are followed up until week 60.
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