Prostate Cancer
Conditions
Keywords
Sipuleucel-T, Castration Resistant Prostate Cancer, Provenge
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years of age * Written informed consent obtained * Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy * No prior systemic chemotherapy for metastatic prostate cancer * Hemoglobin \> 9 mg/dl
Exclusion criteria
* Patients unable to understand the research protocol and/or provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Regulatory T cells (Tregs) | baseline and 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Antigen Presenting Cells | baseline and 1 year | 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 |
| Change in Prostate Antigen-specific T Cell Immunity | baseline and one year | — |
| Whole-blood RNA transcript-based signatures | baseline | whole-blood RNA transcript-based signatures correlate with overall survival |
| Change in cytokine milieu | baseline and 1 year | — |
| Change in chemokine milieu | baseline and 1 year | — |
Countries
United States
Outcome results
None listed