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PROVENGE: Immune Monitoring on Sipuleucel-T

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT02237170
Collaborator
(none)
36
Enrollment
3
Locations
54
Duration (Months)
12
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    36 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
    Study Start Date :
    Jun 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Castration Resistant Metastatic Prostate Cancer

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. Change in Prostate Antigen-specific T Cell Immunity [baseline and one year]

    3. Whole-blood RNA transcript-based signatures [baseline]

      whole-blood RNA transcript-based signatures correlate with overall survival

    4. Whole-blood RNA transcript-based signatures [up to 1 year]

      whole-blood RNA transcript-based signatures correlate with overall survival

    5. Change in cytokine milieu [baseline and 1 year]

    6. Change in chemokine milieu [baseline and 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center of Nevada Las Vegas Nevada United States 89169
    2 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    3 Weill Cornell Medical College New York New York United States 10065

    Sponsors and Collaborators

    • Icahn School of Medicine at Mount Sinai

    Investigators

    • Principal Investigator: Matthew Galsky, MD, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT02237170
    Other Study ID Numbers:
    • GCO 11-1689
    First Posted:
    Sep 11, 2014
    Last Update Posted:
    Jan 4, 2017
    Last Verified:
    Jan 1, 2017
    Keywords provided by Icahn School of Medicine at Mount Sinai
    Sipuleucel-T
    Castration Resistant Prostate Cancer
    Provenge
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jan 4, 2017