<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/NCT02250313</url>
  </required_header>
  <id_info>
    <org_study_id>PASCUAL</org_study_id>
    <nct_id>NCT02250313</nct_id>
  </id_info>
  <brief_title>PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study</brief_title>
  <acronym>PASCUAL</acronym>
  <official_title>PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MDx Health</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MDx Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for&#xD;
      Prostate Cancer test in previously biopsied patients improves urologists' patient management&#xD;
      by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse&#xD;
      events in men being considered for a repeat procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The results of the study will reveal the clinical utility of this test by analyzing the&#xD;
      physicians' use of negative or positive assays compared to patients managed using SOC methods&#xD;
      without assay findings. The repeat biopsy rate at 12 months from study entry will be used for&#xD;
      the primary endpoint analysis. All patients will be followed for 24 months from the date of&#xD;
      the previous negative biopsy to evaluate an extended period of observation to track repeat&#xD;
      biopsies and cancer detection.&#xD;
&#xD;
      The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the&#xD;
      negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All&#xD;
      patients will have the tissue from their previous negative biopsy tested with the assay. Only&#xD;
      data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the&#xD;
      ConfirmMDx assay result) patients with negative test results will be used for the primary&#xD;
      objective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Pending final analysis for termination&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective is to demonstrate the clinical utility of the ConfirmMDx test</measure>
    <time_frame>2 years</time_frame>
    <description>The primary objective is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compare rebiopsy rates assay negative results in cases and controls</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of rebiopsy rates of Cases and Controls with assay negative results at the end of follow up of 24 months from the date of the previous biopsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare rebiopsy rates in assay positive group vs standard of care</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of rebiopsy rates in assay positive results group vs. SOC (blinded) positive assay group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare rebiopsy rates of case and controls</measure>
    <time_frame>2 years</time_frame>
    <description>Comparison of overall rates of rebiopsies of the entire Case vs. Control Cohorts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyse cancer detection rates</measure>
    <time_frame>2 years</time_frame>
    <description>Analysis of cancer detection rates in ConfirmMDx positive and negative arms versus those of Controls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate clinical utility and cost savings by using the ConfirmMDx test</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluate clinical resource utilization, medical complications, and cost impact across groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare rebiopsy rates assay positive results in cases and controls</measure>
    <time_frame>2 years</time_frame>
    <description>Evaluate prostate cancer detection rates after repeat biopsy in the Case and Controls positive and negative groups at the end of 24 months after the previous negative biopsy date.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <description>All patients will have the tissue from their previous negative biopsy tested with the assay. Cases are defined as those subjects who receive the ConfirmMDx assay results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>All patients will have the tissue from their previous negative biopsy tested with the assay. Controls are defined as subjects who will be blinded to the ConfirmMDx assay results.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Archived FFPE prostate biopsy core tissue to be analyzed for this study must have been&#xD;
      collected from a previous, histologically confirmed cancer-negative biopsy. Patients were&#xD;
      considered at risk for prostate cancer due to elevated serum PSA levels, abnormal digital&#xD;
      rectal exam or other risk factor.&#xD;
&#xD;
      Only archived tissues will be used in this study: no new procedures to obtain new samples&#xD;
      from the patient will be done.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate biopsy&#xD;
        within 15 months and being considered for a repeat biopsy due to persistent or elevated&#xD;
        cancer-risk factors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate&#xD;
             biopsy within 15 months and being considered for a repeat biopsy due to persistent or&#xD;
             elevated cancer-risk factors&#xD;
&#xD;
          -  The previous negative prostate biopsy must have collected a minimum of 8 tissue cores&#xD;
             and remaining FFPE tissue from all cores should be available for testing&#xD;
&#xD;
          -  Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue should be&#xD;
             available (40 microns preferable)&#xD;
&#xD;
          -  The presence of HGPIN (high-grade prostatic intraepithelial neoplasia), PIA&#xD;
             (proliferative inflammatory atrophy), or glandular inflammation reported in the first&#xD;
             biopsy histopathology report is acceptable for entry.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (ASAP) in&#xD;
             a previous biopsy histology report.&#xD;
&#xD;
          -  Patients being managed by Active Surveillance for low stage prostate cancer&#xD;
&#xD;
          -  Men greater than 75 years old (generally not considered for repeat biopsy)&#xD;
&#xD;
          -  Most recent biopsy was a saturation biopsy (&gt; 24 tissue cores).&#xD;
&#xD;
          -  Tissue extracted using transurethral resection of the prostate (TURP) procedures&#xD;
             rather than standard patterned biopsy core extraction.&#xD;
&#xD;
          -  Subjects who had been previously tested with ConfirmMDx.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Urology Centers of Alabama</name>
      <address>
        <city>Homewood</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Research LLC</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skyline Urology</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Center of Colorado</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Urology, PSC</name>
      <address>
        <city>Jeffersonville</city>
        <state>Indiana</state>
        <zip>47130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Urology, LLC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>Michigan Institute of Urology</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Medical Professionals of NY</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Urology Institute</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancaster Urology</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Urological 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>Urology Associates, P.C.</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Clinics of North Texas, PLLC</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology San Antonio Research</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>July 24, 2018</last_update_submitted>
  <last_update_submitted_qc>July 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</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/NCT02250313
org study id: PASCUAL
nct id: NCT02250313
lead sponsor: 
has dmc: No
The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for
      Prostate Cancer test in previously biopsied patients improves urologists' patient management
      by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse
      events in men being considered for a repeat procedure.
The results of the study will reveal the clinical utility of this test by analyzing the
      physicians' use of negative or positive assays compared to patients managed using SOC methods
      without assay findings. The repeat biopsy rate at 12 months from study entry will be used for
      the primary endpoint analysis. All patients will be followed for 24 months from the date of
      the previous negative biopsy to evaluate an extended period of observation to track repeat
      biopsies and cancer detection.

      The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the
      negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All
      patients will have the tissue from their previous negative biopsy tested with the assay. Only
      data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the
      ConfirmMDx assay result) patients with negative test results will be used for the primary
      objective.
observational model: Case-Control
time perspective: Prospective
measure: The primary objective is to demonstrate the clinical utility of the ConfirmMDx test
time frame: 2 years
description: The primary objective is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC.
measure: Compare rebiopsy rates assay negative results in cases and controls
time frame: 2 years
description: Comparison of rebiopsy rates of Cases and Controls with assay negative results at the end of follow up of 24 months from the date of the previous biopsy.
measure: Compare rebiopsy rates in assay positive group vs standard of care
time frame: 2 years
description: Comparison of rebiopsy rates in assay positive results group vs. SOC (blinded) positive assay group.
measure: Compare rebiopsy rates of case and controls
time frame: 2 years
description: Comparison of overall rates of rebiopsies of the entire Case vs. Control Cohorts
measure: Analyse cancer detection rates
time frame: 2 years
description: Analysis of cancer detection rates in ConfirmMDx positive and negative arms versus those of Controls
measure: Evaluate clinical utility and cost savings by using the ConfirmMDx test
time frame: 2 years
description: Evaluate clinical resource utilization, medical complications, and cost impact across groups
measure: Compare rebiopsy rates assay positive results in cases and controls
time frame: 2 years
description: Evaluate prostate cancer detection rates after repeat biopsy in the Case and Controls positive and negative groups at the end of 24 months after the previous negative biopsy date.
arm group label: Case
description: All patients will have the tissue from their previous negative biopsy tested with the assay. Cases are defined as those subjects who receive the ConfirmMDx assay results.
arm group label: Control
description: All patients will have the tissue from their previous negative biopsy tested with the assay. Controls are defined as subjects who will be blinded to the ConfirmMDx assay results.
Archived FFPE prostate biopsy core tissue to be analyzed for this study must have been
      collected from a previous, histologically confirmed cancer-negative biopsy. Patients were
      considered at risk for prostate cancer due to elevated serum PSA levels, abnormal digital
      rectal exam or other risk factor.

      Only archived tissues will be used in this study: no new procedures to obtain new samples
      from the patient will be done.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms