Immune Monitoring on Sipuleucel-T

Prostate Cancer Clinical Trial

— PROVENGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237170
• Other study ID #: GCO 11-1689
• Status: Completed
• Phase: N/A
• First received: September 9, 2014
• Last updated: January 3, 2017
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
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	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Change in Prostate Antigen-specific T Cell Immunity		baseline and one year	No
Secondary	Whole-blood RNA transcript-based signatures	whole-blood RNA transcript-based signatures correlate with overall survival	baseline	No
Secondary	Whole-blood RNA transcript-based signatures	whole-blood RNA transcript-based signatures correlate with overall survival	up to 1 year	No
Secondary	Change in cytokine milieu		baseline and 1 year	No
Secondary	Change in chemokine milieu		baseline and 1 year	No