<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/NCT03823001</url>
  </required_header>
  <id_info>
    <org_study_id>CASE9818</org_study_id>
    <nct_id>NCT03823001</nct_id>
  </id_info>
  <brief_title>Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer</brief_title>
  <official_title>Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Case Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the use of MRI surveillance for patients with no&#xD;
      prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use MRI instead of prostate biopsy in combination with regularly scheduled&#xD;
      urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method&#xD;
      for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a&#xD;
      biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative&#xD;
      MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low&#xD;
      risk prostate cancer who are on active surveillance. However, if at any point, clinical&#xD;
      suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA,&#xD;
      and/or positive DRE arises, then an immediate biopsy will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    low accrual&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 2022</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)</measure>
    <time_frame>Up to 3 years from start of study</time_frame>
    <description>Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Virtual prostate biopsy (VB) monitoring</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented:&#xD;
PSA bi-annually or more often according to the discretion of the urologist.&#xD;
Annual DRE.&#xD;
Visit with the urologist bi-annually.&#xD;
Multi-parametric MRI (mpMRI) every year for 3 years.&#xD;
Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>virtual biopsy (VB) monitoring protocol</intervention_name>
    <description>PSA bi-annually or more often according to the discretion of the urologist.&#xD;
Annual DRE.&#xD;
Visit with the urologist bi-annually.&#xD;
Multi-parametric MRI (mpMRI) every year for 3 years.&#xD;
Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.</description>
    <arm_group_label>Virtual prostate biopsy (VB) monitoring</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or&#xD;
&#xD;
          -  Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy;&#xD;
             or&#xD;
&#xD;
          -  Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive DRE;&#xD;
&#xD;
          -  PSA &gt; 10 ng/ml or unstable PSA (doubling time &lt;3 years) during the last year prior to&#xD;
             enrolling in this study;&#xD;
&#xD;
          -  PSAD &gt; 0.15 (calculated using most recent PSA divided by MRI prostate volume);&#xD;
&#xD;
          -  First degree relative diagnosed with prostate cancer&#xD;
&#xD;
          -  First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing&#xD;
             any cancer.&#xD;
&#xD;
          -  Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch&#xD;
             syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation&#xD;
             in the family (Lynch Syndrome) and patient has not had testing; or family history&#xD;
             consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair&#xD;
             gene in the family.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lee Ponsky</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetic Resonance Imaging (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>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication</ipd_time_frame>
    <ipd_access_criteria>To be shared with investigators whose proposed use of the data has been approved by an independent review committee (&quot;learned intermediary&quot;) identified for this purpose.&#xD;
For individual participant data meta-analysis</ipd_access_criteria>
  </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/NCT03823001
org study id: CASE9818
nct id: NCT03823001
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this study is to examine the use of MRI surveillance for patients with no
      prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.
This study will use MRI instead of prostate biopsy in combination with regularly scheduled
      urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method
      for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a
      biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative
      MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low
      risk prostate cancer who are on active surveillance. However, if at any point, clinical
      suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA,
      and/or positive DRE arises, then an immediate biopsy will be performed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
time frame: Up to 3 years from start of study
description: Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.
arm group label: Virtual prostate biopsy (VB) monitoring
arm group type: Experimental
description: Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented:
PSA bi-annually or more often according to the discretion of the urologist.
Annual DRE.
Visit with the urologist bi-annually.
Multi-parametric MRI (mpMRI) every year for 3 years.
Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.
intervention type: Diagnostic Test
intervention name: virtual biopsy (VB) monitoring protocol
description: PSA bi-annually or more often according to the discretion of the urologist.
Annual DRE.
Visit with the urologist bi-annually.
Multi-parametric MRI (mpMRI) every year for 3 years.
Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.
arm group label: Virtual prostate biopsy (VB) monitoring
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lee Ponsky
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication
ipd access criteria: To be shared with investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
For individual participant data meta-analysis