<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/NCT03031418</url>
  </required_header>
  <id_info>
    <org_study_id>ECT2016-001</org_study_id>
    <nct_id>NCT03031418</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the 'ExoDx Prostate IntelliScore' (EPI)</brief_title>
  <official_title>Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exosome Diagnostics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Exosome Diagnostics, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is investigate a new and validated urine test which&#xD;
      predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The&#xD;
      current protocol has two objectives; one is to further assess and evaluate the performance of&#xD;
      the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1)&#xD;
      and two, to evaluate how the results of the urine test influences the decision process for&#xD;
      determining whether to perform a prostate biopsy (cohort (group) 2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective(s)&#xD;
&#xD;
        -  Confirm performance of the ExoDx Prostate (IntelliScore) (EPI) utilizing a designated&#xD;
           collection vessel for men presenting for their initial prostate biopsy with an elevated&#xD;
           Prostate-specific antigen (2-10 ng/mL).&#xD;
&#xD;
        -  Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to&#xD;
           perform an initial prostate biopsy for men presenting with an elevated Prostate-specific&#xD;
           antigen (2-10 ng/mL).&#xD;
&#xD;
      Secondary and Exploratory Objectives&#xD;
&#xD;
        -  Assess physician satisfaction with the ExoIntelliScore Prostate report including test&#xD;
           result presentation, graphics and interpretation.&#xD;
&#xD;
        -  Assess patient satisfaction for ease of understanding test results and role on decision&#xD;
           process to have a biopsy.&#xD;
&#xD;
        -  Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate&#xD;
           biopsy decision process.&#xD;
&#xD;
        -  Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">September 1, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Confirm performance of the ExoDx Prostate IntelliScore</measure>
    <time_frame>6 months</time_frame>
    <description>Confirm performance of the ExoDx Prostate IntelliScore utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated prostate-specific antigen (2-10 ng/mL).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">532</enrollment>
  <condition>Cancer of Prostate</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>Enroll up to 500 patients to confirm performance of ExoDx Prostate IntelliScore (EPI) for men scheduled for initial biopsy. The treating physician will collect a urine sample from from a consented subject to test before their scheduled prostate biopsy (during your established clinic visit).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>Enroll up to 500 patients to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy. The treating physician will collect a urine sample for testing and 2 weeks later discuss whether to perform a prostate biopsy with the subject knowing the results of the urine test and comparing them to the overall consensus report from Cohort 1 as well as other clinical factors the treating physician would otherwise use to determine whether they should have a prostate biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ExoDx Prostate Intelliscore</intervention_name>
    <description>ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.</description>
    <arm_group_label>Cohort 2</arm_group_label>
    <other_name>EPI</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Random first catch urine sample &gt; 20mL&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male, 50+ years of age with a clinical suspicion for prostate cancer based in part on an&#xD;
        elevated Prostate-specific antigen (limit range: 2.0 - 10 ng/ mL), and or suspicious DRE,&#xD;
        without the clinical history of a prior negative biopsy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 years of age&#xD;
&#xD;
          -  Clinical suspicion for prostate cancer&#xD;
&#xD;
          -  Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL&#xD;
&#xD;
          -  No clinical history of a prior negative biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of prior prostate biopsy.&#xD;
&#xD;
          -  Use of medications or hormones that are known to affect serum Prostate-specific&#xD;
             antigen levels within 3-6 months of study enrollment.&#xD;
&#xD;
          -  Clinical symptoms of urinary tract infection (including prostatitis) at the time of&#xD;
             enrollment.&#xD;
&#xD;
          -  History of prostate cancer.&#xD;
&#xD;
          -  History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic&#xD;
             Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.&#xD;
&#xD;
          -  No known hepatitis (all types) and/or HIV documented in patient's medical record.&#xD;
&#xD;
          -  Patients with history of concurrent renal/bladder tumors.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Must be male to screen for prostate cancer</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger Tun</last_name>
    <role>Study Director</role>
    <affiliation>Exosome Diagnostics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>21st Century Oncology</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center of Florida</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Urology Associates</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical CPDR</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Urology</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Five Valley Urology</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Urology Group</name>
      <address>
        <city>Edison</city>
        <state>New Jersey</state>
        <zip>08837</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urologic Research and Consulting LLC</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delaware Valley Urology</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manhattan Medical Research</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Urology Associates</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</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>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Urologists of North Carolina</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urologic Research Center</name>
      <address>
        <city>Myrtle Beach</city>
        <state>South Carolina</state>
        <zip>29572</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Health Science Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology of Virginia</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Donovan MJ, Noerholm M, Bentink S, Belzer S, Skog J, O'Neill V, Cochran JS, Brown GA. A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result. Prostate Cancer Prostatic Dis. 2015 Dec;18(4):370-5. doi: 10.1038/pcan.2015.40. Epub 2015 Sep 8.</citation>
    <PMID>26345389</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>January 23, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03031418
org study id: ECT2016-001
nct id: NCT03031418
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is investigate a new and validated urine test which
      predicts the likelihood of high grade prostate cancer on an initial prostate biopsy The
      current protocol has two objectives; one is to further assess and evaluate the performance of
      the urine test in men already scheduled for initial prostate needle biopsy (cohort (group) 1)
      and two, to evaluate how the results of the urine test influences the decision process for
      determining whether to perform a prostate biopsy (cohort (group) 2).
Primary Objective(s)

        -  Confirm performance of the ExoDx Prostate (IntelliScore) (EPI) utilizing a designated
           collection vessel for men presenting for their initial prostate biopsy with an elevated
           Prostate-specific antigen (2-10 ng/mL).

        -  Evaluate impact of the confirmed ExoDx Prostate (IntelliScore) on the decision to
           perform an initial prostate biopsy for men presenting with an elevated Prostate-specific
           antigen (2-10 ng/mL).

      Secondary and Exploratory Objectives

        -  Assess physician satisfaction with the ExoIntelliScore Prostate report including test
           result presentation, graphics and interpretation.

        -  Assess patient satisfaction for ease of understanding test results and role on decision
           process to have a biopsy.

        -  Determine the medical economic impact of the ExoIntelliScore Prostate in the prostate
           biopsy decision process.

        -  Correlation of the ExoIntelliScore Prostate score with the actual biopsy result.
observational model: Cohort
time perspective: Prospective
measure: Confirm performance of the ExoDx Prostate IntelliScore
time frame: 6 months
description: Confirm performance of the ExoDx Prostate IntelliScore utilizing a designated collection vessel for men presenting for their initial prostate biopsy with an elevated prostate-specific antigen (2-10 ng/mL).
arm group label: Cohort 1
description: Enroll up to 500 patients to confirm performance of ExoDx Prostate IntelliScore (EPI) for men scheduled for initial biopsy. The treating physician will collect a urine sample from from a consented subject to test before their scheduled prostate biopsy (during your established clinic visit).
arm group label: Cohort 2
description: Enroll up to 500 patients to evaluate how the results of the urine test influences the decision process for determining whether to perform a prostate biopsy. The treating physician will collect a urine sample for testing and 2 weeks later discuss whether to perform a prostate biopsy with the subject knowing the results of the urine test and comparing them to the overall consensus report from Cohort 1 as well as other clinical factors the treating physician would otherwise use to determine whether they should have a prostate biopsy.
intervention type: Diagnostic Test
intervention name: ExoDx Prostate Intelliscore
description: ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.
arm group label: Cohort 2
other name: EPI
Random first catch urine sample > 20mL
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Must be male to screen for prostate cancer
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Roger Tun
role: Study Director
affiliation: Exosome Diagnostics, Inc.
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country: United States
citation: Donovan MJ, Noerholm M, Bentink S, Belzer S, Skog J, O'Neill V, Cochran JS, Brown GA. A molecular signature of PCA3 and ERG exosomal RNA from non-DRE urine is predictive of initial prostate biopsy result. Prostate Cancer Prostatic Dis. 2015 Dec;18(4):370-5. doi: 10.1038/pcan.2015.40. Epub 2015 Sep 8.
PMID: 26345389
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Undecided