Immune Monitoring on Sipuleucel-T

Study Overview
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Brief Summary
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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
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The primary objectives of this study are to: Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T. Determine the induction and the quality of prostate antigen-specific T cell immunity in patients undergoing treatment with Sipuleucel-T. Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients treated with Sipuleucel-T. Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and post-treatment with Sipuleucel-T.

Official Title
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A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Castration Resistant Metastatic Prostate Cancer<br>Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline and 1 year | 
| Change in Prostate Antigen-specific T Cell Immunity |  | baseline and one year | 
| Whole-blood RNA transcript-based signatures | whole-blood RNA transcript-based signatures correlate with overall survival | baseline | 
| Whole-blood RNA transcript-based signatures | whole-blood RNA transcript-based signatures correlate with overall survival | up to 1 year | 
| Change in cytokine milieu |  | baseline and 1 year | 
| Change in chemokine milieu |  | baseline and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sipuleucel-T, Castration Resistant Prostate Cancer, Provenge