Overview

This trial is active, not recruiting.

Condition prostate cancer
Sponsor Icahn School of Medicine at Mount Sinai
Start date June 2012
End date December 2016
Trial size 36 participants
Trial identifier NCT02237170, GCO 11-1689

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy

Primary Outcomes

Measure
Change in Regulatory T cells (Tregs)
time frame: baseline and 1 year

Secondary Outcomes

Measure
Change in Antigen Presenting Cells
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
time frame: baseline
Whole-blood RNA transcript-based signatures
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

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
Principal investigator Matthew Galsky, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai.