<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/NCT02220517</url>
  </required_header>
  <id_info>
    <org_study_id>003</org_study_id>
    <nct_id>NCT02220517</nct_id>
  </id_info>
  <brief_title>Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy</brief_title>
  <official_title>A Prospective Randomized Study Comparing the Diagnostic Efficacy of MR-guided in Bore Prostate Biopsy Versus MRI/US Fusion-guided Prostate Biopsy in Men With at Least One Negative Prostate Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heinrich-Heine University, Duesseldorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heinrich-Heine University, Duesseldorf</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with&#xD;
      additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more&#xD;
      prostate cancers than targeted MR-guided in-bore prostate.&#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 strategy offers the highest detection rate for&#xD;
      prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined&#xD;
      with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than&#xD;
      MRI-guided prostate biopsies alone.&#xD;
&#xD;
      Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA&#xD;
      values will be submitted to a multiparametric MRI examination of the prostate. Subsequently,&#xD;
      all participants will be randomized (1:1) into both study arms. In study arm A patients will&#xD;
      be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted&#xD;
      biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted&#xD;
      biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with&#xD;
      software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional&#xD;
      systematic 12-core TRUS-guided prostate biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prostate cancer detection rate</measure>
    <time_frame>1 week after biopsy</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">480</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>A: MR-guided in-bore prostate biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: MRI/US fusion-guided prostate biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MR-guided in-bore prostate biopsy</intervention_name>
    <description>Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.</description>
    <arm_group_label>A: MR-guided in-bore prostate biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI/US fusion-guided prostate biopsy</intervention_name>
    <description>Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)</description>
    <arm_group_label>B: MRI/US fusion-guided prostate biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one prior negative prostate biopsy&#xD;
&#xD;
          -  Prostate-specific antigen (PSA) &gt; 4 ng/ml&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known prostate cancer&#xD;
&#xD;
          -  Contraindications against MRI&#xD;
&#xD;
          -  Contraindications against prostate biopsy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Arsov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, University of Düsseldorf</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>March 23, 2015</last_update_submitted>
  <last_update_submitted_qc>March 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI/US fusion-guided prostate biopsy</keyword>
  <keyword>MR-guided in-bore prostate biopsy</keyword>
  <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/NCT02220517
org study id: 003
nct id: NCT02220517
lead sponsor: 
has dmc: No
The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with
      additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more
      prostate cancers than targeted MR-guided in-bore prostate.
In men with previously negative prostate biopsy and persistent elevated prostate-specific
      antigen (PSA) value, it is unclear which strategy offers the highest detection rate for
      prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined
      with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than
      MRI-guided prostate biopsies alone.

      Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA
      values will be submitted to a multiparametric MRI examination of the prostate. Subsequently,
      all participants will be randomized (1:1) into both study arms. In study arm A patients will
      be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted
      biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted
      biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with
      software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional
      systematic 12-core TRUS-guided prostate biopsy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Prostate cancer detection rate
time frame: 1 week after biopsy
arm group label: A: MR-guided in-bore prostate biopsy
arm group type: Experimental
description: Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
arm group label: B: MRI/US fusion-guided prostate biopsy
arm group type: Experimental
description: Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
intervention type: Device
intervention name: MR-guided in-bore prostate biopsy
description: Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
arm group label: A: MR-guided in-bore prostate biopsy
intervention type: Device
intervention name: MRI/US fusion-guided prostate biopsy
description: Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
arm group label: B: MRI/US fusion-guided prostate biopsy
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Arsov, MD
role: Principal Investigator
affiliation: Department of Urology, University of Düsseldorf
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Prostatic Neoplasms