<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/NCT03762616</url>
  </required_header>
  <id_info>
    <org_study_id>EVU-2018-001</org_study_id>
    <nct_id>NCT03762616</nct_id>
  </id_info>
  <brief_title>Urology San Antonio MRI/MicroUS Comparison</brief_title>
  <official_title>Urology San Antonio MRI/MicroUS Comparison</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Exact Imaging</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Exact Imaging</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI&#xD;
      targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer.&#xD;
      Both imaging techniques will be applied to each subject and compared, along with systematic&#xD;
      biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigational protocol describes a study designed to compare ultra-high resolution&#xD;
      transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities&#xD;
      are both used clinically to identify targets for prostate biopsy, however little data is&#xD;
      available to compare their sensitivity. While mpMRI is used clinically to identify targets&#xD;
      for biopsy, it is not used for real-time biopsy guidance due to challenges performing the&#xD;
      biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled&#xD;
      during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often&#xD;
      using software assisted fusion products. For this investigation, the biopsy procedure will be&#xD;
      guided by transrectal micro-US (current standard of care at Urology San Antonio), and will&#xD;
      include systematic (standard, random, extended sextant) plus image-guided prostate biopsies&#xD;
      among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2018</start_date>
  <completion_date type="Actual">November 4, 2019</completion_date>
  <primary_completion_date type="Actual">November 4, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigator performing the micro-ultrasound biopsy will be blinded to the MRI report, and the investigator performing the MRI targeted biopsy will be blinded to the micro-ultrasound images and targets.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Cancer</measure>
    <time_frame>At time of biopsy</time_frame>
    <description>Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Micro-Ultrasound Biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MRI Targeted Biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Micro-ultrasound targeted biopsy</intervention_name>
    <description>Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system</description>
    <arm_group_label>Micro-Ultrasound Biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>mpMRI targeted biopsy</intervention_name>
    <description>Multiparametric MRI targeted biopsy using software assisted MRI/US fusion</description>
    <arm_group_label>MRI Targeted Biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men presenting for prostate biopsy due to clinical suspicion of prostate cancer&#xD;
&#xD;
          2. 40-75 years old&#xD;
&#xD;
          3. Available mpMRI images and report, performed according to the PI-RADS v2 standard&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy&#xD;
&#xD;
          2. Men who are unable to provide their own informed consent&#xD;
&#xD;
          3. Prostate volume on MRI &gt; 100cc&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David R Talley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Urology San Antonio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology San Antonio - Pasteur Plaza Surgery Center</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>March 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <results_first_submitted>March 2, 2021</results_first_submitted>
  <results_first_submitted_qc>March 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2021</results_first_posted>
  <last_update_submitted>March 25, 2021</last_update_submitted>
  <last_update_submitted_qc>March 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multiparametric MRI</keyword>
  <keyword>micro-ultrasound</keyword>
  <keyword>prostate biopsy</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03762616/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Micro-ultrasound Biopsy Then MRI Biopsy</title>
          <description>Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by MRI biopsy by a second blinded operator</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Micro-ultrasound Biopsy Then MRI Biopsy</title>
          <description>Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system Followed in the same session by... mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="118"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" lower_limit="62" upper_limit="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Cancer</title>
        <description>Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.</description>
        <time_frame>At time of biopsy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Micro-ultrasound Biopsy</title>
            <description>Micro-ultrasound biopsy: Micro-ultrasound biopsy using the ExactVu micro-ultrasound system</description>
          </group>
          <group group_id="O2">
            <title>MRI Targeted Biopsy</title>
            <description>mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Cancer</title>
          <description>Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During biopsy procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Micro-ultrasound Targeted Biopsy</title>
          <description>Micro-ultrasound targeted biopsy: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system</description>
        </group>
        <group group_id="E2">
          <title>MRI Targeted Biopsy</title>
          <description>mpMRI targeted biopsy: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="118"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to issues with marking of targeted samples the primary endpoint was modified to distinguish between the two devices used in the arms rather than biopsy annotations.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Brian Wodlinger</name_or_title>
      <organization>Exact Imaging</organization>
      <phone>6475279032</phone>
      <email>bwodlinger@exactimaging.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03762616
org study id: EVU-2018-001
nct id: NCT03762616
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study compares micro-ultrasound image targeted prostate biopsy with multi-parametric MRI
      targeted biopsy in men indicated for prostate biopsy due to suspicion of prostate cancer.
      Both imaging techniques will be applied to each subject and compared, along with systematic
      biopsy.
The investigational protocol describes a study designed to compare ultra-high resolution
      transrectal micro-ultrasound (micro-US), and multi-parametric MRI (mpMRI). These modalities
      are both used clinically to identify targets for prostate biopsy, however little data is
      available to compare their sensitivity. While mpMRI is used clinically to identify targets
      for biopsy, it is not used for real-time biopsy guidance due to challenges performing the
      biopsy procedure within the MRI gantry. Instead, targets identified on mpMRI are sampled
      during transrectal ultrasound guided biopsy as part of the prostate biopsy procedure, often
      using software assisted fusion products. For this investigation, the biopsy procedure will be
      guided by transrectal micro-US (current standard of care at Urology San Antonio), and will
      include systematic (standard, random, extended sextant) plus image-guided prostate biopsies
      among men with clinical suspicion of prostate cancer and an indication for prostate biopsy.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
masking description: Investigator performing the micro-ultrasound biopsy will be blinded to the MRI report, and the investigator performing the MRI targeted biopsy will be blinded to the micro-ultrasound images and targets.
measure: Number of Participants With Clinically Significant Cancer
time frame: At time of biopsy
description: Comparison of subject-level detection rate of clinically significant cancer (csPCa, defined as Grade Group 2 or higher) between micro-ultrasound targeted biopsy and mpMRI targeted biopsy.
arm group label: Micro-Ultrasound Biopsy
arm group type: Experimental
arm group label: MRI Targeted Biopsy
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Micro-ultrasound targeted biopsy
description: Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
arm group label: Micro-Ultrasound Biopsy
intervention type: Diagnostic Test
intervention name: mpMRI targeted biopsy
description: Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
arm group label: MRI Targeted Biopsy
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: David R Talley, MD
role: Principal Investigator
affiliation: Urology San Antonio
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to issues with marking of targeted samples the primary endpoint was modified to distinguish between the two devices used in the arms rather than biopsy annotations.
point of contact: 