<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/NCT03807492</url>
  </required_header>
  <id_info>
    <org_study_id>18D.644</org_study_id>
    <nct_id>NCT03807492</nct_id>
  </id_info>
  <brief_title>Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)</brief_title>
  <official_title>Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Cancer Center at Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine&#xD;
      rates of genetic mutations among men with or at-risk for prostate cancer to address the&#xD;
      various facets of genetic education and counseling for optimized genetic assessment and&#xD;
      wellness of men. The results will inform practice guidelines and future studies for maximal&#xD;
      impact of genetic evaluation of men for inherited prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Anticipated">March 2024</completion_date>
  <primary_completion_date type="Anticipated">January 19, 2024</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>Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.</measure>
    <time_frame>6 months</time_frame>
    <description>Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>EMPOWeR Study</arm_group_label>
    <description>This is a cohort study, with initial patient assessments and longitudinal follow-up. Participation of subjects will be indefinite, which will be discussed in the informed consent.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any male &gt;18 years with prostate cancer is eligible. Furthermore, unaffected men at higher&#xD;
        risk for prostate cancer (family history of prostate cancer or African American males) are&#xD;
        also eligible for the study. Men will be approached by their providers or study staff&#xD;
        during their clinical appointments for participation. Emails or mailings may also be sent&#xD;
        to introduce the study to patients and to contact us for participation. Men who previously&#xD;
        participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered&#xD;
        participation in EMPOWeR.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with a personal history of prostate cancer&#xD;
&#xD;
          -  Unaffected males who are at higher risk for prostate cancer (family history of&#xD;
             prostate cancer or African American males)&#xD;
&#xD;
          -  Men who previously tested positive for a mutation may be eligible for Specific Aims&#xD;
             2-7&#xD;
&#xD;
          -  Men with a known familial mutation&#xD;
&#xD;
          -  Men who previously participated in the Genetic Evaluation of Men (GEM) study&#xD;
             (IRB#14S.546) will be offered participation in EMPOWeR -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Mental or cognitive impairment that interferes with ability to provide informed&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>As this is a study on prostate cancer, women and children are not included. Minorities meeting eligibility criteria may participate in the study.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hospitals.jefferson.edu/</url>
    <description>Thomas Jefferson University Hospital</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</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/NCT03807492
org study id: 18D.644
nct id: NCT03807492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine
      rates of genetic mutations among men with or at-risk for prostate cancer to address the
      various facets of genetic education and counseling for optimized genetic assessment and
      wellness of men. The results will inform practice guidelines and future studies for maximal
      impact of genetic evaluation of men for inherited prostate cancer.
observational model: Cohort
time perspective: Prospective
measure: Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.
time frame: 6 months
description: Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics.
arm group label: EMPOWeR Study
description: This is a cohort study, with initial patient assessments and longitudinal follow-up. Participation of subjects will be indefinite, which will be discussed in the informed consent.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: As this is a study on prostate cancer, women and children are not included. Minorities meeting eligibility criteria may participate in the study.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
url: http://hospitals.jefferson.edu/
description: Thomas Jefferson University Hospital
responsible party type: Sponsor
mesh term: Prostatic Neoplasms