<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/NCT04420702</url>
  </required_header>
  <id_info>
    <org_study_id>201908215</org_study_id>
    <secondary_id>R01CA258690</secondary_id>
    <nct_id>NCT04420702</nct_id>
  </id_info>
  <brief_title>Diffusion Basis Spectrum Imaging of the Prostate</brief_title>
  <official_title>Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Foundation for Barnes-Jewish Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Midwest Stone Institute.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving&#xD;
      prostate cancer early detection: a non-invasive and accurate imaging test for clinically&#xD;
      significant prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 27, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2027</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>-Dr. Kim will be blinded to the DBSI results at the time of biopsy, but will have the conventional MRI interpretation available</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve (AUC) comparison from biopsy and DBSI</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard&#xD;
In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered &quot;clinically significant&quot;. The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Receiver operating characteristic (ROC) comparison from biopsy to DBSI</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard&#xD;
In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered &quot;clinically significant&quot;. The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sector</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>-Only for those patients with a suspicious MRI lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation</measure>
    <time_frame>Up to 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Early Detection Cohort (MRI with DBSI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy&#xD;
Standard of care prostate biopsy will be performed within 12 weeks of MRI&#xD;
Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Surveillance Cohort (MRI with DBSI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy&#xD;
Standard of care prostate biopsy will be performed within 12 weeks of MRI&#xD;
Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI with DBSI analysis</intervention_name>
    <description>-The procedure will take approximately 1 hour of the participant's time</description>
    <arm_group_label>Active Surveillance Cohort (MRI with DBSI)</arm_group_label>
    <arm_group_label>Early Detection Cohort (MRI with DBSI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age and willing and able to provide informed consent.&#xD;
&#xD;
          -  Patients with no prior diagnosis of prostate cancer, who are planning to undergo&#xD;
             prostate biopsy as clinical standard of care (&quot;early detection cohort&quot;)&#xD;
&#xD;
          -  Including those men with:&#xD;
&#xD;
               -  an elevated PSA and no prior biopsy&#xD;
&#xD;
               -  an elevated PSA and a negative prior biopsy&#xD;
&#xD;
          -  Patients with a prior diagnosis of prostate cancer, who are currently managed with&#xD;
             active surveillance, who are planning to undergo biopsy as clinical standard of care&#xD;
             (&quot;active surveillance cohort&quot;)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any clinical contraindication to MRI&#xD;
&#xD;
             *Including but not limited to:&#xD;
&#xD;
               -  Those with metallic implants, such as pacemakers or implantable&#xD;
                  cardioverter-defibrillators&#xD;
&#xD;
               -  Those with cochlear implants&#xD;
&#xD;
               -  Those with claustrophobia&#xD;
&#xD;
               -  Those who cannot lie flat for over 1 hour&#xD;
&#xD;
          -  Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy,&#xD;
             focal ablation)&#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>Eric Kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eric H Kim, M.D.</last_name>
    <phone>314-747-9781</phone>
    <email>ehkim@wustl.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alex Klim</last_name>
    <phone>314-747-9781</phone>
    <email>klima@wustl.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric H Kim, M.D.</last_name>
      <phone>314-747-9781</phone>
      <email>ehkim@wustl.edu</email>
    </contact>
    <contact_backup>
      <last_name>Alex Kim</last_name>
      <phone>314-747-9781</phone>
      <email>klima@wustl.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Eric H Kim, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sheng-Kwei Song, Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joseph E Ippolito, M.D., Ph.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT04420702
org study id: 201908215
secondary id: R01CA258690
nct id: NCT04420702
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving
      prostate cancer early detection: a non-invasive and accurate imaging test for clinically
      significant prostate cancer.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
masking description: -Dr. Kim will be blinded to the DBSI results at the time of biopsy, but will have the conventional MRI interpretation available
measure: Area under the curve (AUC) comparison from biopsy and DBSI
time frame: Up to 12 weeks
description: As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard
In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.
measure: Receiver operating characteristic (ROC) comparison from biopsy to DBSI
time frame: Up to 12 weeks
description: As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard
In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.
measure: Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sector
time frame: Up to 12 weeks
measure: Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology
time frame: Up to 12 weeks
description: -Only for those patients with a suspicious MRI lesion
measure: Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation
time frame: Up to 12 weeks
measure: Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation
time frame: Up to 12 weeks
arm group label: Early Detection Cohort (MRI with DBSI)
arm group type: Experimental
description: Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy
Standard of care prostate biopsy will be performed within 12 weeks of MRI
Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging
arm group label: Active Surveillance Cohort (MRI with DBSI)
arm group type: Experimental
description: Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy
Standard of care prostate biopsy will be performed within 12 weeks of MRI
Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging
intervention type: Device
intervention name: MRI with DBSI analysis
description: -The procedure will take approximately 1 hour of the participant's time
arm group label: Active Surveillance Cohort (MRI with DBSI)
arm group label: Early Detection Cohort (MRI with DBSI)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Kim, M.D.
role: Principal Investigator
affiliation: Washington University School of Medicine
last name: Eric H Kim, M.D.
phone: 314-747-9781
email: ehkim@wustl.edu
last name: Alex Klim
phone: 314-747-9781
email: klima@wustl.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No