The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.
The primary objectives of this study are to: 1. Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T. 2. Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T. 3. Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T. 4. Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.
Study Type
OBSERVATIONAL
Enrollment
36
Comprehensive Cancer Center of Nevada
Las Vegas, Nevada, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Change in Regulatory T cells (Tregs)
Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in regulatory T cells at 1 year post treatment compared to at baseline
Time frame: baseline and 1 year
Change in Antigen Presenting Cells
Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in antigen presenting cells: DCs and B cells at 1 year post treatment compared to at baseline
Time frame: baseline and 1 year
Change in Prostate Antigen-specific T Cell Immunity
Time frame: baseline and one year
Whole-blood RNA transcript-based signatures
whole-blood RNA transcript-based signatures correlate with overall survival
Time frame: baseline
Whole-blood RNA transcript-based signatures
whole-blood RNA transcript-based signatures correlate with overall survival
Time frame: up to 1 year
Change in cytokine milieu
Time frame: baseline and 1 year
Change in chemokine milieu
Time frame: baseline and 1 year
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