<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/NCT03044197</url>
  </required_header>
  <id_info>
    <org_study_id>17-0013</org_study_id>
    <nct_id>NCT03044197</nct_id>
  </id_info>
  <brief_title>Detection of Clinically Significant Prostate Cancer Using Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy</brief_title>
  <official_title>Assessing the Detection of Clinically Significant Prostate Cancer Using Magnetic Resonance Imaging-Guided Transperineal Targeted Biopsy Compared to Standard Transrectal Biopsy Outcomes Study: The ASTROS Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many&#xD;
      biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With&#xD;
      multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of&#xD;
      increasing the detection of detecting clinically significant prostate cancer (csPCa) while&#xD;
      decreasing the detection of non-significant PCa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In men with previously negative prostate biopsy and persistent elevated prostate-specific&#xD;
      antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate&#xD;
      for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound&#xD;
      fusion-guided biopsy improves the detection rates of clinically significant prostate cancers&#xD;
      (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.&#xD;
&#xD;
      Patients who fulfill all eligibility criteria and have provided written consent will be&#xD;
      randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B).&#xD;
      Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization&#xD;
      procedure according to a computer-generated randomization list. The primary end point will be&#xD;
      the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined&#xD;
      according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for&#xD;
      targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for&#xD;
      SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral&#xD;
      cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa&#xD;
      and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm&#xD;
      A mpMRI+ and arm B.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">April 12, 2018</completion_date>
  <primary_completion_date type="Actual">April 12, 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>Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Prostate Cancer</measure>
    <time_frame>Within 2-4 wks after biopsy</time_frame>
    <description>Number of subjects with positive clinically significant prostate cancer results</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B</measure>
    <time_frame>Within 2-4 wks from biopsy</time_frame>
    <description>Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of UTI Incidence in Arm A mpMRI+ and Arm B</measure>
    <time_frame>From the time of biopsy through 4 weeks post-biopsy</time_frame>
    <description>Number of confirmed UTIs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <condition>Target Lesion</condition>
  <condition>Fusion Biopsy</condition>
  <condition>Clinically Significant Prostate Cancer</condition>
  <condition>Transperineal</condition>
  <arm_group>
    <arm_group_label>MRI/ultrasound transperineal prostate biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS&lt;3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>transrectal ultrasound-guided prostate biopsy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI/ultrasound transperineal prostate biopsy</intervention_name>
    <description>3-6 targeted biopsy cores from each prostate region of interest</description>
    <arm_group_label>MRI/ultrasound transperineal prostate biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transrectal ultrasound-guided prostate biopsy</intervention_name>
    <description>12 systematic biopsy cores</description>
    <arm_group_label>transrectal ultrasound-guided prostate biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males aged 18-75 years old&#xD;
&#xD;
          2. PSA &gt;1 ng/ml but &lt;15 ng/ml&#xD;
&#xD;
          3. Negative DRE&#xD;
&#xD;
          4. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous prostate biopsy or prostate surgery&#xD;
&#xD;
          2. Previous prostate mpMRI&#xD;
&#xD;
          3. Contraindication to mpMRI: patients with pacemakers, defibrillators or other implanted&#xD;
             electronic devices&#xD;
&#xD;
          4. Patients in the Texas Department of Criminal Justice (prisoners)&#xD;
&#xD;
          5. Patients with acute urinary symptoms including urinary retention and urinary tract&#xD;
             infection&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen B Williams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Medical Branch at Galveston</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <results_first_submitted>April 18, 2019</results_first_submitted>
  <results_first_submitted_qc>April 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 9, 2019</results_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>magnetic resonance imaging</keyword>
  <keyword>transperineal biopsy</keyword>
  <keyword>target lesion</keyword>
  <keyword>fusion biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Erythema Multiforme</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>December 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/97/NCT03044197/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MRI/Ultrasound Transperineal Prostate Biopsy</title>
          <description>In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS&lt;3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.&#xD;
MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest</description>
        </group>
        <group group_id="P2">
          <title>Transrectal Ultrasound-guided Prostate Biopsy</title>
          <description>TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.&#xD;
transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>3 subjects in Arm A and 1 subject in Arm B withdrew from the study.</population>
      <group_list>
        <group group_id="B1">
          <title>MRI/Ultrasound Transperineal Prostate Biopsy</title>
          <description>In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS&lt;3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.&#xD;
MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest</description>
        </group>
        <group group_id="B2">
          <title>Transrectal Ultrasound-guided Prostate Biopsy</title>
          <description>TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.&#xD;
transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>3 subjects in Arm A and 1 subject in Arm B withdrew from the study.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" lower_limit="56" upper_limit="71"/>
                    <measurement group_id="B2" value="60" lower_limit="54" upper_limit="68"/>
                    <measurement group_id="B3" value="62" lower_limit="54" 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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </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 Prostate Cancer</title>
        <description>Number of subjects with positive clinically significant prostate cancer results</description>
        <time_frame>Within 2-4 wks after biopsy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MRI/Ultrasound Transperineal Prostate Biopsy</title>
            <description>In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS&lt;3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.&#xD;
MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest</description>
          </group>
          <group group_id="O2">
            <title>Transrectal Ultrasound-guided Prostate Biopsy</title>
            <description>TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.&#xD;
transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Prostate Cancer</title>
          <description>Number of subjects with positive clinically significant prostate cancer results</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="9"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B</title>
        <description>Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.</description>
        <time_frame>Within 2-4 wks from biopsy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MRI/Ultrasound Transperineal Prostate Biopsy</title>
            <description>In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS&lt;3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.&#xD;
MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest</description>
          </group>
          <group group_id="O2">
            <title>Transrectal Ultrasound-guided Prostate Biopsy</title>
            <description>TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.&#xD;
transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B</title>
          <description>Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.</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="9"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Comparison of UTI Incidence in Arm A mpMRI+ and Arm B</title>
        <description>Number of confirmed UTIs</description>
        <time_frame>From the time of biopsy through 4 weeks post-biopsy</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MRI/Ultrasound Transperineal Prostate Biopsy</title>
            <description>In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS&lt;3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.&#xD;
MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest</description>
          </group>
          <group group_id="O2">
            <title>Transrectal Ultrasound-guided Prostate Biopsy</title>
            <description>TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.&#xD;
transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores</description>
          </group>
        </group_list>
        <measure>
          <title>Comparison of UTI Incidence in Arm A mpMRI+ and Arm B</title>
          <description>Number of confirmed UTIs</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="9"/>
                <count group_id="O2" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Time of biopsy through 2 to 4 weeks post biopsy</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MRI/Ultrasound Transperineal Prostate Biopsy</title>
          <description>In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS&lt;3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.&#xD;
MRI/ultrasound transperineal prostate biopsy: 3-6 targeted biopsy cores from each prostate region of interest</description>
        </group>
        <group group_id="E2">
          <title>Transrectal Ultrasound-guided Prostate Biopsy</title>
          <description>TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.&#xD;
transrectal ultrasound-guided prostate biopsy: 12 systematic biopsy cores</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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <point_of_contact>
      <name_or_title>Lori Simon</name_or_title>
      <organization>UTexasGalveston</organization>
      <phone>409-772-1978</phone>
      <email>lasimon@utmb.edu</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/NCT03044197
org study id: 17-0013
nct id: NCT03044197
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Prostate biopsies are currently the gold standard for the diagnosis of prostate cancer. Many
      biopsies, however, are unnecessary or cannot detect significant prostate cancer (PCa). With
      multi-parametric magnetic resonance imaging (mpMRI) we now potentially have a way of
      increasing the detection of detecting clinically significant prostate cancer (csPCa) while
      decreasing the detection of non-significant PCa.
In men with previously negative prostate biopsy and persistent elevated prostate-specific
      antigen (PSA) value, it is unclear which biopsy strategy offers the highest detection rate
      for significant prostate cancer. The hypothesis of this study is that targeted MRI/ultrasound
      fusion-guided biopsy improves the detection rates of clinically significant prostate cancers
      (csPCa) compared with systematic transrectal ultrasound-guided prostate biopsy.

      Patients who fulfill all eligibility criteria and have provided written consent will be
      randomized to undergo MRI followed by biopsies (arm A) or TRUS transrectal biopsy (arm-B).
      Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization
      procedure according to a computer-generated randomization list. The primary end point will be
      the comparison of detection rates csPCa between arm A and arm B. csPCa will be defined
      according to the Standards of Reporting for MRI-targeted Biopsy Studies (START) criteria for
      targeted biopsy Gleason Score ≥ 7 or maximum CCL ≥ 5 mm and the updated Epstein criteria for
      SB (Gleason score ≥ 7, PSA density ≥ 0.15, Gleason score ≥ 2 positive cores, and bilateral
      cancer). The secondary end points will be (1) Comparison of the overall detection rate of PCa
      and csPCa between arm A mpMRI+ and arm B and (2) Comparison of complication rates between arm
      A mpMRI+ and arm B.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomly assigned to arm A or arm B following a 1:1 simple randomization procedure according to a computer-generated randomization list.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants With Clinically Significant Prostate Cancer
time frame: Within 2-4 wks after biopsy
description: Number of subjects with positive clinically significant prostate cancer results
measure: Overall Detection Rate of Prostate Cancer Between Arm A mpMRI+ and Arm B
time frame: Within 2-4 wks from biopsy
description: Number of overall positive prostate cancer (Combined positive and clinically significant positive results) Not all positive prostate biopsies are considered clinically significant. Clinically significant results indicate further work up and/or treatment. Physicians and patients may choose not to just monitor non-clinically significant prostate results for future changes. The overall detection rate will report the total number of both non-clinically significant positive results and clinically significant results.
measure: Comparison of UTI Incidence in Arm A mpMRI+ and Arm B
time frame: From the time of biopsy through 4 weeks post-biopsy
description: Number of confirmed UTIs
arm group label: MRI/ultrasound transperineal prostate biopsy
arm group type: Experimental
description: In arm A, all patients with positive mpMRI evidence of lesions suspicious for PCa, i.e. PI RADS ≥ 3 will be submitted to transperineal mpMRI-targeted prostate biopsy (arm A MRI+). The gland and the regions of interest will be contoured, and the prostate contour will be fused in real time with the TRUS image. Biopsies will be performed via a transperineal approach in the operating room. The patient will be placed in dorsal lithotomy position. mpMRI-targeted biopsies will be performed on regions of interest, and three to six cores will be obtained for biopsy from each lesion and is standard of care according to START criteria for targeted biopsy. In cases of negative mpMRI results i.e. PI RADS<3, arm A patients will undergo TRUS-guided transrectal 12-core prostate biopsy (arm A MRI-) as described in arm B.
arm group label: transrectal ultrasound-guided prostate biopsy
arm group type: Active Comparator
description: TRUS-guided transrectal prostate biopsy will be performed using a disposable 18-gauge biopsy gun with a specimen size of 18-22 mm (Bard Medical, Covington, GA, USA). The 12 cores will be obtained from 12 separate anatomical regions of the prostate which is standard practice in performing TRUS-guided transrectal prostate biopsy: left medial apex, left lateral apex, left medial midgland, left lateral midgland, left medial base, left lateral base, right medial apex, right lateral apex, right medial midgland, right lateral midgland, right medial base and right lateral base.
intervention type: Device
intervention name: MRI/ultrasound transperineal prostate biopsy
description: 3-6 targeted biopsy cores from each prostate region of interest
arm group label: MRI/ultrasound transperineal prostate biopsy
intervention type: Device
intervention name: transrectal ultrasound-guided prostate biopsy
description: 12 systematic biopsy cores
arm group label: transrectal ultrasound-guided prostate biopsy
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen B Williams, MD
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Erythema Multiforme
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 