This pilot clinical trial studies the impact of radiation therapy on the immunogenicity of Sipuleucel-T. Patients with castration recurrent prostate cancer who are eligible for treatment with Sipuleucel-T and who have bone metastases are eligible.
PRIMARY OBJECTIVES: I. To assess whether radiation therapy (RT) increases the immunogenic potential or sipuleucel-T in participants with castration recurrent prostate cancer. II. To assess systemic changes to the immune system and genetic changes to immune cells in participants treated by the combination of RT and sipuleucel-T. III. To assess the induction of antigen-specific immune responses to prostatic acid phosphatase (PAP), cancer/testis antigen 1B (NY-ESO-1) and antigens that have proven to be released by radiation (such as, heat shock protein 90 \[HSP-90\], calreticulin, etc.). SECONDARY OBJECTIVES: I. To assess adverse event rates in participants receiving the high-dose radiation and sipuleucel-T therapy. II. To assess prostate-specific antigen (PSA) changes. III. To assess overall and cancer specific survival. OUTLINE: Patients undergo single-fraction radiation therapy to at least 1 bone lesion 2 days after the first sipuleucel-T dose. After completion of study treatment, patients are followed up at 3 and 6 months and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Correlative studies
Undergo single-fraction radiation therapy
Roswell Park Cancer Institute
Buffalo, New York, United States
Western New York Urology Associates LLC-Harlem
Cheektowaga, New York, United States
Capacity of T cells to proliferate in response to antigen stimulation, assessed with a tritiated thymidine incorporation assay and an interferon-gamma enzyme-linked immunosorbent spot assay
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
Time frame: Up to 6 months
Change in antigen-specific humoral response measured via enzyme-linked immunosorbent assay
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
Time frame: Baseline up to 6 months
Change in the genetics of immune effectors, measured with ribonucleic acid from monocytic and lymphocytic cells
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
Time frame: Baseline to 6 months
Quantification of lymphocyte subsets and NK cells
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
Time frame: Baseline to 6 months
Adverse event rates assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4
The Clopper-Pearson one-sided upper 95% confidence limit will be provided. Associations between baseline characteristics and presence of an adverse event will be considered using the Wilcoxon rank sum test (or Cochran-Armitage test for trend) and Fisher's exact test respectively. Bar charts, scatterplots and other descriptive and graphical methods will also be utilized.
Time frame: Up to 6 months
Cancer-specific survival
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Will be depicted using Kaplan Meier methods.
Time frame: Up to 2 years
Change in PSA
Time frame: Baseline up to 6 months
Overall survival
Will be depicted using Kaplan Meier methods.
Time frame: Up to 2 years