<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/NCT02232230</url>
  </required_header>
  <id_info>
    <org_study_id>21C-2013-02</org_study_id>
    <nct_id>NCT02232230</nct_id>
  </id_info>
  <brief_title>A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T</brief_title>
  <official_title>A Multicenter Trial Enrolling Men With Advanced Prostate Cancer Who Are to Receive Combination Radiation and Sipuleucel-T</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GenesisCare USA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dendreon</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GenesisCare USA</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Radiation in combination with Provenge based immunotherapy may improve outcomes seen on&#xD;
      imaging as well as immunologic monitoring. This study will assess the effect of radiation&#xD;
      therapy to augment anti-tumor responses from immune therapy with Provenge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is common knowledge that the host can make anti-tumor immune responses, although often&#xD;
      these are ineffective in causing tumor regression. Boosting these responses with&#xD;
      immunotherapy is therefore an attractive, relatively benign adjunctive cancer treatment.&#xD;
      Little is known in regards to how standard anti-cancer therapies like radiation therapy might&#xD;
      interact with immunotherapy in a clinical setting. We are interested in knowing if the tumor&#xD;
      cell death occasioned by radiation therapy might augment anti-tumor responses from the immune&#xD;
      therapy, Provenge.&#xD;
&#xD;
      The tentative assumption is that cell death following radiation therapy will stimulate&#xD;
      anti-tumor immunity, which could provide a more permanent solution to curing cancer and&#xD;
      discouraging tumors from spreading throughout the body. In order to find out if this&#xD;
      assumption is correct, for patients undergoing radiation 28 days prior to Provenge, highly&#xD;
      developed, laboratory analyses for tumor-specific immunity and imaging will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 5, 2018</completion_date>
  <primary_completion_date type="Actual">June 5, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in immune stimulation</measure>
    <time_frame>At 52 Weeks post first injection of sipuleucel-T</time_frame>
    <description>The percentage of subjects who exhibit a two-fold increase in peripheral immune response at any post-treatment time point (6, 10, 14, 26, 39 and 52 weeks after the first infusion of sipuleucel-T) utilizing IFNγ ELISPOT response to PA2024.</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Castrate Refractory Metastatic Prostate Cancer (mCRPC)</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Provenge</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men with castrate refractory metastatic prostate cancer (mCRPC).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Subjects will be recruited from the population of patients who are&#xD;
        castrate refractory metastatic prostate cancer (mCRPC) and have made the decision to be&#xD;
        treated with radiation therapy to one or more metastatic sites of concern followed at least&#xD;
        28 days later by Provenge.&#xD;
&#xD;
        Exclusion Criteria: The potential subject is unwilling or hesitant to participate for any&#xD;
        reason and/or fails to complete the appropriate Informed Consent Form.&#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>Steven Finkelstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GenesisCare USA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>21st Century Oncology</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02232230
org study id: 21C-2013-02
nct id: NCT02232230
lead sponsor: 
collaborator: 
has dmc: Yes
Radiation in combination with Provenge based immunotherapy may improve outcomes seen on
      imaging as well as immunologic monitoring. This study will assess the effect of radiation
      therapy to augment anti-tumor responses from immune therapy with Provenge.
It is common knowledge that the host can make anti-tumor immune responses, although often
      these are ineffective in causing tumor regression. Boosting these responses with
      immunotherapy is therefore an attractive, relatively benign adjunctive cancer treatment.
      Little is known in regards to how standard anti-cancer therapies like radiation therapy might
      interact with immunotherapy in a clinical setting. We are interested in knowing if the tumor
      cell death occasioned by radiation therapy might augment anti-tumor responses from the immune
      therapy, Provenge.

      The tentative assumption is that cell death following radiation therapy will stimulate
      anti-tumor immunity, which could provide a more permanent solution to curing cancer and
      discouraging tumors from spreading throughout the body. In order to find out if this
      assumption is correct, for patients undergoing radiation 28 days prior to Provenge, highly
      developed, laboratory analyses for tumor-specific immunity and imaging will be performed.
observational model: Cohort
time perspective: Retrospective
measure: Change in immune stimulation
time frame: At 52 Weeks post first injection of sipuleucel-T
description: The percentage of subjects who exhibit a two-fold increase in peripheral immune response at any post-treatment time point (6, 10, 14, 26, 39 and 52 weeks after the first infusion of sipuleucel-T) utilizing IFNγ ELISPOT response to PA2024.
intervention type: Drug
intervention name: Provenge
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Finkelstein, MD
role: Principal Investigator
affiliation: GenesisCare USA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms