Pilot: Impact of High-Dose, Single Fraction Radiation on Immunogenicity of Sipuleucel-T in Metastatic Castration Recurrent Prostate Cancer Patients
I. To assess whether radiation therapy (RT) increases the immunogenic potential or
sipuleucel-T in patients with castration recurrent prostate cancer.
II. To assess systemic changes to the immune system and genetic changes to immune cells in
patients 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.).
I. To assess adverse event rates in patients receiving the high-dose radiation and
II. Prostate-specific antigen (PSA) changes will be assessed. III. Overall and cancer
specific survival will be assessed.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Capacity of T cells to proliferate in response to antigen stimulation, assessed with a tritiated thymidine incorporation assay and an IFN-gamma ELISPOT assay
Will be assessed using Wilcoxon Signed Rank and McNemar's tests for continuous and dichotomous endpoints respectively.
Up to 6 months
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|