xml: <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/NCT06029088</url>
    </required_header>
    <id_info>
      <org_study_id>I05-328-23</org_study_id>
      <nct_id>NCT06029088</nct_id>
    </id_info>
    <brief_title>Risk-adapted Strategy Including Magnetic Resonance Imaging and Prostate-specific Antigen Density in Blood for Biopsy Decision in Patients With Lesions Suspicious for Prostate Cancer</brief_title>
    <official_title>Risk-adapted Strategy Combining Magnetic Resonance Imaging and Prostate-specific Antigen Density to Individualize Biopsy Decision in Patients With PI-RADS 3 'Gray Zone' Lesions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ankara Etlik City Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ankara Etlik City Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
    </oversight_info>
    <brief_summary>
      <textblock>
        Recent guidelines now recommend multi parametric magnetic resonance imaging prior to biopsy&#xD;
        for all men as an integral part of improved diagnosis of clinical significant prostate&#xD;
        cancer. However, magnetic resonance imaging targeted biopsy is a strategy that focuses on&#xD;
        maximizing detection of clinical significant prostate cancer, but this procedure has the&#xD;
        disadvantage of leading to higher detection of clinically insignificant prostate cancers. One&#xD;
        of the risk-stratifications developed to minimize the existing disadvantages and avoid&#xD;
        unnecessary biopsy procedures is a strategy in which multi parametric magnetic resonance&#xD;
        imaging and prostate-specific antigen density are used in combination. This is especially&#xD;
        important in all patients with PI-RADS (Prostate Imaging Reporting and Data System) 3 lesions&#xD;
        which are also interpreted as indeterminate mpMRI findings. Current guidelines suggest that&#xD;
        biopsy may be omitted in some patient groups with PI-RADS 3 lesions in the risk-adapted&#xD;
        strategy involving prostate-specific antigen density. The aim of this study was to evaluate&#xD;
        the role of risk-adapted strategies involving prostate-specific antigen density in biopsy&#xD;
        decision to avoid unnecessary biopsy vs the risk of missing clinical significant prostate&#xD;
        cancer diagnosis in patients with PI-RADS 3 lesions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 12, 2023</start_date>
    <completion_date type="Actual">June 16, 2023</completion_date>
    <primary_completion_date type="Actual">May 21, 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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement</measure>
      <time_frame>2 weeks from the outpatient clinic admission</time_frame>
    </primary_outcome>
    <enrollment type="Actual">616</enrollment>
    <condition>Prostate Cancer</condition>
    <condition>Prostate Adenocarcinoma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          tertiary care clinic&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients who all had undergone multi parametric magnetic resonance imaging at our&#xD;
               hospital&#xD;
  &#xD;
            -  Patients who all had undergone transrectal ultrasonography guided cognitive and fusion&#xD;
               targeted biopsies&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Magnetic resonance imaging at exterior hospitals&#xD;
  &#xD;
            -  Insufficient image quality/artifacts&#xD;
  &#xD;
            -  Previous prostate biopsy and/or prior prostate cancer diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Because prostate cancer is a male-specific disease</gender_description>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Ankara University School of Medicine</name>
        <address>
          <city>Ankara</city>
          <zip>06100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ankara Etlik City Hospital</investigator_affiliation>
      <investigator_full_name>Cagri Akpinar</investigator_full_name>
      <investigator_title>M.D.</investigator_title>
    </responsible_party>
    <keyword>Prostate cancer</keyword>
    <keyword>Risk-adapted strategy</keyword>
    <keyword>Magnetic resonance imaging</keyword>
    <keyword>Prostate-specific antigen density</keyword>
    <keyword>PIRADS</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>
  
  
text: 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/NCT06029088
  org study id: I05-328-23
  nct id: NCT06029088
  lead sponsor: 
  has dmc: No
  Recent guidelines now recommend multi parametric magnetic resonance imaging prior to biopsy
        for all men as an integral part of improved diagnosis of clinical significant prostate
        cancer. However, magnetic resonance imaging targeted biopsy is a strategy that focuses on
        maximizing detection of clinical significant prostate cancer, but this procedure has the
        disadvantage of leading to higher detection of clinically insignificant prostate cancers. One
        of the risk-stratifications developed to minimize the existing disadvantages and avoid
        unnecessary biopsy procedures is a strategy in which multi parametric magnetic resonance
        imaging and prostate-specific antigen density are used in combination. This is especially
        important in all patients with PI-RADS (Prostate Imaging Reporting and Data System) 3 lesions
        which are also interpreted as indeterminate mpMRI findings. Current guidelines suggest that
        biopsy may be omitted in some patient groups with PI-RADS 3 lesions in the risk-adapted
        strategy involving prostate-specific antigen density. The aim of this study was to evaluate
        the role of risk-adapted strategies involving prostate-specific antigen density in biopsy
        decision to avoid unnecessary biopsy vs the risk of missing clinical significant prostate
        cancer diagnosis in patients with PI-RADS 3 lesions.
  observational model: Cohort
  time perspective: Retrospective
  measure: Reducing unnecessary prostate biopsy with the combined use of magnetic resonance imaging and prostat-specific antigen density measurement
  time frame: 2 weeks from the outpatient clinic admission
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Because prostate cancer is a male-specific disease
  minimum age: 45 Years
  maximum age: 75 Years
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ankara Etlik City Hospital
  investigator full name: Cagri Akpinar
  investigator title: M.D.
  mesh term: Prostatic Neoplasms