<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02237170</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 11-1689</org_study_id>
    <nct_id>NCT02237170</nct_id>
  </id_info>
  <brief_title>Immune Monitoring on Sipuleucel-T</brief_title>
  <acronym>PROVENGE</acronym>
  <official_title>A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this protocol is perform comprehensive immune monitoring studies in patients&#xD;
      with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better&#xD;
      understand the mechanism of action of this treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objectives of this study are to:&#xD;
&#xD;
        1. Establish the phenotype and frequency of circulating immune cell compartments in&#xD;
           patients undergoing treatment with Sipuleucel-T.&#xD;
&#xD;
        2. Determine the induction and the quality of prostate antigen-specific T cell immunity in&#xD;
           patients undergoing treatment with Sipuleucel-T.&#xD;
&#xD;
        3. Correlate whole-blood RNA transcript-based signatures with clinical outcomes in patients&#xD;
           treated with Sipuleucel-T.&#xD;
&#xD;
        4. Evaluate the cytokine and chemokine milieu in the peripheral blood pre- and&#xD;
           post-treatment with Sipuleucel-T.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Regulatory T cells (Tregs)</measure>
    <time_frame>baseline and 1 year</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Antigen Presenting Cells</measure>
    <time_frame>baseline and 1 year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Prostate Antigen-specific T Cell Immunity</measure>
    <time_frame>baseline and one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-blood RNA transcript-based signatures</measure>
    <time_frame>baseline</time_frame>
    <description>whole-blood RNA transcript-based signatures correlate with overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whole-blood RNA transcript-based signatures</measure>
    <time_frame>up to 1 year</time_frame>
    <description>whole-blood RNA transcript-based signatures correlate with overall survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cytokine milieu</measure>
    <time_frame>baseline and 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in chemokine milieu</measure>
    <time_frame>baseline and 1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Castration Resistant Metastatic Prostate Cancer</arm_group_label>
    <description>Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from those patients who receive their care at Mount Sinai&#xD;
        Medical Center, or a participating site&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years of age&#xD;
&#xD;
          -  Written informed consent obtained&#xD;
&#xD;
          -  Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as&#xD;
             standard therapy&#xD;
&#xD;
          -  No prior systemic chemotherapy for metastatic prostate cancer&#xD;
&#xD;
          -  Hemoglobin &gt; 9 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to understand the research protocol and/or provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Galsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Comprehensive Cancer Center of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sipuleucel-T</keyword>
  <keyword>Castration Resistant Prostate Cancer</keyword>
  <keyword>Provenge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02237170
org study id: GCO 11-1689
nct id: NCT02237170
lead sponsor: 
has dmc: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Change in Regulatory T cells (Tregs)
time frame: baseline and 1 year
description: 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
measure: Change in Antigen Presenting Cells
time frame: baseline and 1 year
description: 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
measure: Change in Prostate Antigen-specific T Cell Immunity
time frame: baseline and one year
measure: Whole-blood RNA transcript-based signatures
time frame: baseline
description: whole-blood RNA transcript-based signatures correlate with overall survival
measure: Whole-blood RNA transcript-based signatures
time frame: up to 1 year
description: whole-blood RNA transcript-based signatures correlate with overall survival
measure: Change in cytokine milieu
time frame: baseline and 1 year
measure: Change in chemokine milieu
time frame: baseline and 1 year
arm group label: Castration Resistant Metastatic Prostate Cancer
description: Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy
whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Galsky, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms