<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/NCT03749993</url>
  </required_header>
  <id_info>
    <org_study_id>VISIONING1</org_study_id>
    <nct_id>NCT03749993</nct_id>
  </id_info>
  <brief_title>Evaluation of a MRI-based Prostate Cancer Screening Program</brief_title>
  <acronym>VISIONING</acronym>
  <official_title>Evaluation of a MRI-based Prostate Cancer Screening Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effort and resources (incl. costs) required to&#xD;
      detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of&#xD;
      the prostate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Informed men at risk for prostate cancer will be included into the study to undergo prostate&#xD;
      cancer screening. According to European guidelines we will include men &gt; 50 years of age and&#xD;
      men &gt;45 years of age and a family history of PCA as well as African-Americans &gt;45 years of&#xD;
      age. In this study, bpMRI will be used for opportunistic prostate cancer screening.&#xD;
&#xD;
      The indication for prostate biopsy is based solely on the results of bpMRI. In case of&#xD;
      detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion&#xD;
      biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA (&#xD;
      PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for&#xD;
      PCA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">May 1, 2023</completion_date>
  <primary_completion_date type="Actual">April 1, 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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total costs of the MRI based prostate cancer screening</measure>
    <time_frame>24 months</time_frame>
    <description>Total costs of the program</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of costs of classical screening based on PSA and DRE</measure>
    <time_frame>24 months</time_frame>
    <description>Total costs per patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients undergoing active surveillance</measure>
    <time_frame>24 months</time_frame>
    <description>Number of follow-up interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients undergoing radical cystoprostatectomy</measure>
    <time_frame>24 months</time_frame>
    <description>Number of follow-up interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients undergoing radiotherapy</measure>
    <time_frame>24 months</time_frame>
    <description>Number of follow-up interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients undergoing androgen deprivation therapy</measure>
    <time_frame>24 months</time_frame>
    <description>Number of follow-up interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients undergoing chemotherapy</measure>
    <time_frame>24 months</time_frame>
    <description>Number of follow-up interventions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (Qol)</measure>
    <time_frame>24 months</time_frame>
    <description>Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer Assessment</measure>
    <time_frame>24 months</time_frame>
    <description>&quot;Distress Thermometer&quot; score (0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AI Evaluation</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients</measure>
    <time_frame>24 months</time_frame>
    <description>Number of patients needed to screen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of consultations</measure>
    <time_frame>24 months</time_frame>
    <description>Number of total consultations</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Screening Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Screening</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Screening</intervention_name>
    <description>Use of bpMRI for opportunistic prostate cancer screening.</description>
    <arm_group_label>Screening Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  well-informed men with the wish for prostate cancer screening&#xD;
&#xD;
          -  prostate biopsy naïve&#xD;
&#xD;
          -  life expectancy &gt; 10 years&#xD;
&#xD;
          -  men &gt; 50 years of age&#xD;
&#xD;
          -  men &gt; 45 years of age with a family history of prostate cancer&#xD;
&#xD;
          -  African-Americans &gt; 45 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prostate biopsy performed prior to study&#xD;
&#xD;
          -  life expectancy &lt; 10 years&#xD;
&#xD;
          -  acute urinary tract infection&#xD;
&#xD;
          -  NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)&#xD;
&#xD;
          -  IPSS score 20 (leads to initiation of urologic diagnostics and treatment)&#xD;
&#xD;
        Contraindications for MRI:&#xD;
&#xD;
          -  Heart pacemaker&#xD;
&#xD;
          -  Artificial heart valves (some types are eligible)&#xD;
&#xD;
          -  Cochlea implant&#xD;
&#xD;
          -  ICD&#xD;
&#xD;
          -  Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump,&#xD;
             etc.)&#xD;
&#xD;
          -  Severe claustrophobia&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening.</gender_description>
    <minimum_age>46 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cyrill Rentsch, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel, Clinic of Urology</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03749993
org study id: VISIONING1
nct id: NCT03749993
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the effort and resources (incl. costs) required to
      detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of
      the prostate.
Informed men at risk for prostate cancer will be included into the study to undergo prostate
      cancer screening. According to European guidelines we will include men > 50 years of age and
      men >45 years of age and a family history of PCA as well as African-Americans >45 years of
      age. In this study, bpMRI will be used for opportunistic prostate cancer screening.

      The indication for prostate biopsy is based solely on the results of bpMRI. In case of
      detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion
      biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA (
      PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for
      PCA.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Total costs of the MRI based prostate cancer screening
time frame: 24 months
description: Total costs of the program
measure: Comparison of costs of classical screening based on PSA and DRE
time frame: 24 months
description: Total costs per patient
measure: number of patients undergoing active surveillance
time frame: 24 months
description: Number of follow-up interventions
measure: number of patients undergoing radical cystoprostatectomy
time frame: 24 months
description: Number of follow-up interventions
measure: number of patients undergoing radiotherapy
time frame: 24 months
description: Number of follow-up interventions
measure: number of patients undergoing androgen deprivation therapy
time frame: 24 months
description: Number of follow-up interventions
measure: number of patients undergoing chemotherapy
time frame: 24 months
description: Number of follow-up interventions
measure: Quality of Life (Qol)
time frame: 24 months
description: Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case
measure: Distress Thermometer Assessment
time frame: 24 months
description: "Distress Thermometer" score (0-10)
measure: AI Evaluation
time frame: 24 months
description: Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic
measure: Number of patients
time frame: 24 months
description: Number of patients needed to screen
measure: Number of consultations
time frame: 24 months
description: Number of total consultations
arm group label: Screening Arm
arm group type: Other
description: Screening
intervention type: Other
intervention name: Screening
description: Use of bpMRI for opportunistic prostate cancer screening.
arm group label: Screening Arm
criteria: 
gender: Male
gender based: Yes
gender description: Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening.
minimum age: 46 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cyrill Rentsch, MD PHD
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No