<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/NCT03784924</url>
  </required_header>
  <id_info>
    <org_study_id>430</org_study_id>
    <nct_id>NCT03784924</nct_id>
  </id_info>
  <brief_title>EDRN Prostate MRI Biomarker Study</brief_title>
  <acronym>P-MRI</acronym>
  <official_title>EDRN Prostate MRI Biomarker Study and Reference Set</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use&#xD;
      of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy&#xD;
      setting given the availability of validated prostate cancer early detection markers is&#xD;
      uncertain.This study will allow investigators to determine if prostate MRI is superior to&#xD;
      validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial&#xD;
      biopsy setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to see if the addition of prostate MRI to a panel consisting&#xD;
      of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate&#xD;
      cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine,&#xD;
      blood and tissue biomarkers that will select those cases most likely to benefit from a MRI&#xD;
      targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which&#xD;
      ones are value added in the setting of initial biopsy, 3) evaluate changes in these&#xD;
      biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade&#xD;
      prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this&#xD;
      study will create a unique, prospective, cohort that will become the foundational reference&#xD;
      set for of a range of future biomarker studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinically significant prostate cancer</measure>
    <time_frame>2 years</time_frame>
    <description>Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>PSA</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Initial prostate biopsy</arm_group_label>
    <description>Men who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI prostate</intervention_name>
    <description>MRI and laboratory biomarkers</description>
    <arm_group_label>Initial prostate biopsy</arm_group_label>
    <other_name>urine and blood biomarkers</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      8 x 250ul and 10 x 100ul Serum 10 x 200ul EDTA Plasma&#xD;
&#xD;
      1 x 500ul Buffy Coat&#xD;
&#xD;
      1 x 1ml Whole Blood from EDTA Tube 2 x 1ml Unprocessed Raw Urine 2 x 2.5ml Whole Urine 2 x&#xD;
      5ml Supernatant&#xD;
&#xD;
      1 x 50ul Pellet/Sediment FFPE tumor tissue (blocks) from all cancer foci Nitrocellulose&#xD;
      tissue prints from all cores&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Urology clinics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with suspected but undiagnosed prostate cancer&#xD;
&#xD;
          -  To be scheduled/scheduled for biopsy as routine clinical care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to obtain blood and urine per SOP or conduct an attentive DRE&#xD;
&#xD;
          -  Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI&#xD;
&#xD;
          -  Prior diagnosis of prostate cancer&#xD;
&#xD;
          -  Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one&#xD;
             year prior to consent date)&#xD;
&#xD;
          -  Participating in clinical trial for prostate disease&#xD;
&#xD;
          -  Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift&#xD;
&#xD;
          -  Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John T Wei, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jackie Dahlgren</last_name>
    <phone>206-667-3438</phone>
    <email>jdahlgre@fredhutch.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John T Wei, MD</last_name>
      <phone>734-615-3040</phone>
      <email>jtw@med.umich.edu</email>
    </contact>
    <contact_backup>
      <last_name>Rabia Martin</last_name>
      <phone>7347637508</phone>
      <email>rabia@med.umich.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>John Wei</investigator_full_name>
    <investigator_title>David A Bloom Professor of Urology, Medical Director of Brighton Center for Specialty Care and Professor of Urology, Medical School</investigator_title>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>psa</keyword>
  <keyword>early detection</keyword>
  <keyword>MRI</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>
  <!-- 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/NCT03784924
org study id: 430
nct id: NCT03784924
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use
      of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy
      setting given the availability of validated prostate cancer early detection markers is
      uncertain.This study will allow investigators to determine if prostate MRI is superior to
      validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial
      biopsy setting.
The primary aim of this study is to see if the addition of prostate MRI to a panel consisting
      of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate
      cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine,
      blood and tissue biomarkers that will select those cases most likely to benefit from a MRI
      targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which
      ones are value added in the setting of initial biopsy, 3) evaluate changes in these
      biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade
      prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this
      study will create a unique, prospective, cohort that will become the foundational reference
      set for of a range of future biomarker studies.
observational model: Cohort
time perspective: Prospective
measure: Clinically significant prostate cancer
time frame: 2 years
description: Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy
arm group label: Initial prostate biopsy
description: Men who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy.
intervention type: Diagnostic Test
intervention name: MRI prostate
description: MRI and laboratory biomarkers
arm group label: Initial prostate biopsy
other name: urine and blood biomarkers
8 x 250ul and 10 x 100ul Serum 10 x 200ul EDTA Plasma

      1 x 500ul Buffy Coat

      1 x 1ml Whole Blood from EDTA Tube 2 x 1ml Unprocessed Raw Urine 2 x 2.5ml Whole Urine 2 x
      5ml Supernatant

      1 x 50ul Pellet/Sediment FFPE tumor tissue (blocks) from all cancer foci Nitrocellulose
      tissue prints from all cores
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John T Wei, MD, MS
role: Principal Investigator
affiliation: University of Michigan
last name: Jackie Dahlgren
phone: 206-667-3438
email: jdahlgre@fredhutch.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: John Wei
investigator title: David A Bloom Professor of Urology, Medical Director of Brighton Center for Specialty Care and Professor of Urology, Medical School
mesh term: Prostatic Neoplasms
sharing ipd: No