<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/NCT03235687</url>
  </required_header>
  <id_info>
    <org_study_id>ECT2017-002</org_study_id>
    <nct_id>NCT03235687</nct_id>
  </id_info>
  <brief_title>Decision Impact Trial of the ExoDx Prostate (IntelliScore)</brief_title>
  <official_title>A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exosome Diagnostics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CareFirst BlueCross BlueShield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chesapeake Urology Research Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Exosome Diagnostics, Inc.</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 purpose of this research study is to investigate the utility of a validated urine test&#xD;
      which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective(s)&#xD;
&#xD;
        1. Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of&#xD;
           initial prostate biopsies by greater than or equal to 15% for men with an elevated&#xD;
           Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their&#xD;
           urologist.&#xD;
&#xD;
        2. Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with&#xD;
           respect to the biopsy decision process.&#xD;
&#xD;
        3. Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including&#xD;
           test result presentation, graphics and interpretation.&#xD;
&#xD;
        4. Assess urologist / patient satisfaction for ease of understanding test results and role&#xD;
           on biopsy decision process.&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        1. Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the&#xD;
           prostate biopsy decision process.&#xD;
&#xD;
        2. Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by&#xD;
           utilizing the Receiver Operating Characteristic of the Area Under Curve for&#xD;
           discriminating high-grade (greater than or equal to Gleason Score 7, International&#xD;
           Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International&#xD;
           Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 19, 2017</start_date>
  <completion_date type="Anticipated">September 29, 2023</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a prospective, randomized blinded, shared decision-impact and health-economic assessment study. 1000 appropriately screened consecutive patients seen during planning for a prostate biopsy will be enrolled. 500 patients will be randomized (blinded) to have the ExoDx Prostate (IntelliScore) test (Cohort A) and 500 (Cohort B) will proceed with conventional standard of care. At time of enrollment, neither the patient nor the urologist will be made aware of whether the patient will have an ExoDx Prostate (IntelliScore) test as part of their work-up. Cohort A EPI test results will be sent to the urologist for assessment and ultimately shared with the patient.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate performance of the ExoDx Prostate(IntelliScore)</measure>
    <time_frame>6 Months</time_frame>
    <description>Evaluate performance of the ExoDx Prostate(IntelliScore) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated prostate specific antigen between 2-10ng/mL presenting for a biopsy in consultation with their urologist.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Cancer of the Prostate</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to Cohort B will proceed with conventional standard of care.</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 A</arm_group_label>
    <other_name>EPI</other_name>
  </intervention>
  <eligibility>
    <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;
          -  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>
  <overall_official>
    <last_name>Ronald F Tutrone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chesapeake Urology Research Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chesapeake Urology Research Associates</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Tutrone R, Donovan MJ, Torkler P, Tadigotla V, McLain T, Noerholm M, Skog J, McKiernan J. Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):607-614. doi: 10.1038/s41391-020-0237-z. Epub 2020 May 7.</citation>
    <PMID>32382078</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>May 3, 2022</last_update_submitted>
  <last_update_submitted_qc>May 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 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>
  <patient_data>
    <sharing_ipd>No</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/NCT03235687
org study id: ECT2017-002
nct id: NCT03235687
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to investigate the utility of a validated urine test
      which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.
Primary Objective(s)

        1. Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of
           initial prostate biopsies by greater than or equal to 15% for men with an elevated
           Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their
           urologist.

        2. Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with
           respect to the biopsy decision process.

        3. Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including
           test result presentation, graphics and interpretation.

        4. Assess urologist / patient satisfaction for ease of understanding test results and role
           on biopsy decision process.

      Secondary Objectives

        1. Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the
           prostate biopsy decision process.

        2. Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by
           utilizing the Receiver Operating Characteristic of the Area Under Curve for
           discriminating high-grade (greater than or equal to Gleason Score 7, International
           Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International
           Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a prospective, randomized blinded, shared decision-impact and health-economic assessment study. 1000 appropriately screened consecutive patients seen during planning for a prostate biopsy will be enrolled. 500 patients will be randomized (blinded) to have the ExoDx Prostate (IntelliScore) test (Cohort A) and 500 (Cohort B) will proceed with conventional standard of care. At time of enrollment, neither the patient nor the urologist will be made aware of whether the patient will have an ExoDx Prostate (IntelliScore) test as part of their work-up. Cohort A EPI test results will be sent to the urologist for assessment and ultimately shared with the patient.
primary purpose: Screening
masking: Triple (Participant, Care Provider, Investigator)
measure: Evaluate performance of the ExoDx Prostate(IntelliScore)
time frame: 6 Months
description: Evaluate performance of the ExoDx Prostate(IntelliScore) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated prostate specific antigen between 2-10ng/mL presenting for a biopsy in consultation with their urologist.
arm group label: Cohort A
arm group type: Experimental
description: Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation.
arm group label: Cohort B
arm group type: No Intervention
description: Patients randomized to Cohort B will proceed with conventional standard of care.
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 A
other name: EPI
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.
last name: Ronald F Tutrone, MD
role: Principal Investigator
affiliation: Chesapeake Urology Research Associates
facility: 
country: United States
citation: Tutrone R, Donovan MJ, Torkler P, Tadigotla V, McLain T, Noerholm M, Skog J, McKiernan J. Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):607-614. doi: 10.1038/s41391-020-0237-z. Epub 2020 May 7.
PMID: 32382078
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No