This study aims to evaluate patients with metastatic castrate-resistant prostate cancer (mCRPC) undergoing treatment with sipuleucel-T for evidence of treatment-associated immune activation in lymph nodes and peripheral blood.
This is a pilot study of mCRPC patients planning to undergo therapy with sipuleucel-T immunotherapy. Consenting patients will be randomized 3:1 between immediate sipuleucel-T immunotherapy followed by lymph node biopsy (the post-treatment experimental group) or immediate lymph node biopsy followed by sipuleucel-T immunotherapy (the pre-treatment control group). Peripheral blood will be collected before, during, and after treatment with sipuleucel-T and evaluated for evidence of sipuleucel-T induced immune activation. Lymph nodes collected at biopsy will also be evaluated for evidence of sipuleucel-T induced immune activation. Patients will be followed for 3 months for safety and 6 months for disease progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Duke University Medical Center
Durham, North Carolina, United States
anti-PA2024 immune response in lymph node-derived leukocytes
Proportion of patients with lymph node-derived leukocytes showing anti-PA2024 activity as measured by IFNγ ELISPOT
Time frame: Lymph node biopsy, approximately 10 weeks
anti-PAP immune response in lymph node-derived leukocytes
Proportion of patients with lymph node-derived leukocytes showing anti-PAP activity as measured by IFNγ ELISPOT
Time frame: Lymph node biopsy, approximately 10 weeks
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Time frame: Baseline
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Time frame: Baseline
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Time frame: Prior to sipuleucel-T infusion 2, approximately 6 weeks
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Time frame: Prior to sipuleucel-T infusion 2, approximately 6 weeks
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Time frame: Prior to sipuleucel-T infusion 3, approximately 8 weeks
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anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Time frame: Prior to sipuleucel-T infusion 3, approximately 8 weeks
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Time frame: 2 weeks after the last sipuleucel-T infusion
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Time frame: 2 weeks after the last sipuleucel-T infusion
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Time frame: 3 months post-treatment
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Time frame: 3 months post-treatment
anti-PA2024 immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PA2024 activity as measured by IFNγ ELISPOT at each time point
Time frame: 6 months post-treatment
anti-PAP immune response in PBMCs
Proportion of patients with PBMC samples showing anti-PAP activity as measured by IFNγ ELISPOT at each time point
Time frame: 6 months post-treatment
Serum anti-PA2024 antibody level
Describe any relationship between the magnitude of sipuleucel-T induced leukocyte activation observed in tumor-bearing lymph nodes with systemic (i.e. peripheral blood) studies of sipuleucel-T-induced immune activation
Time frame: Baseline, up to 6 months post-treatment
serum anti-PAP antibody level
Describe any relationship between the magnitude of sipuleucel-T induced leukocyte activation observed in tumor-bearing lymph nodes with systemic (i.e. peripheral blood) studies of sipuleucel-T-induced immune activation
Time frame: Baseline, up to 6 months post-treatment