Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer
Adenocarcinoma of the Prostate, Bone Metastases, Hormone-resistant Prostate Cancer
About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
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
Sites / Locations
- City of Hope Medical Center
- South Pasadena Cancer Center
- Huntsman Cancer Institute, Univ. of Utah
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A (sipuleucel-T)
Arm B (radiation therapy, sipuleucel-T)
Patients receive sipuleucel-T IV over 60 minutes days 22, 36, and 50.
Patients undergo external beam radiation therapy in weeks 1-2. Patients also receive sipuleucel-T as in Arm A.