Immune Monitoring on Sipuleucel-T (PROVENGE)

January 3, 2017 updated by: Icahn School of Medicine at Mount Sinai

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Center of Nevada
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited from those patients who receive their care at Mount Sinai Medical Center, or a participating site

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Castration Resistant Metastatic Prostate Cancer
Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Regulatory T cells (Tregs)
Time Frame: 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
baseline and 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 11-1689

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe