Immune Monitoring on Sipuleucel-T

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT02237170
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change in chemokine milieu	baseline and 1 year
Whole-blood RNA transcript-based signatures	up to 1 year	whole-blood RNA transcript-based signatures correlate with overall survival
Change in cytokine milieu	baseline and 1 year

Trial Locations

Locations (3)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Comprehensive Cancer Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States