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/NCT06027203</url>
    </required_header>
    <id_info>
      <org_study_id>MUMC-Pbx23</org_study_id>
      <nct_id>NCT06027203</nct_id>
    </id_info>
    <brief_title>Transperineal Versus Transrectal Prostate Biopsy</brief_title>
    <official_title>Freehand Transperineal Prostate Biopsies Without Antibiotic Prophylaxis - the New Gold Standard?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maastricht University Medical Center</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>
        Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal&#xD;
        prostate biopsies (TR-PB) are commonly performed, however disadvantages include the&#xD;
        requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal&#xD;
        prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the&#xD;
        limited evidence regarding complication rates after their omission. However, the rising rates&#xD;
        of antibiotic resistance is of concern. The aim of this study was to compare the complication&#xD;
        and detection rates of freehand TP-PB without AP versus TR-PB with AP.&#xD;
  &#xD;
        Methods: This single center retrospective study was performed in an academic hospital. TP-PB&#xD;
        were introduced in 2019 and implemented as the main technique by late 2020. To compare the&#xD;
        two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand&#xD;
        TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the&#xD;
        effects of the initial learning curve during the transition period. Primary outcome measure&#xD;
        was post-biopsy complications occurring within 2 weeks, focusing on infectious complications.&#xD;
        Secondary outcome measures were detection rates and upgrading/reclassification in the repeat&#xD;
        biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact&#xD;
        or Chi-Squared test.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 15, 2023</start_date>
    <completion_date type="Actual">July 18, 2023</completion_date>
    <primary_completion_date type="Actual">June 15, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Complications</measure>
      <time_frame>2 weeks</time_frame>
      <description>Urinary tract infections, urinary retention, hematuria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Detection rate</measure>
      <time_frame>2 weeks</time_frame>
      <description>Chance of detecting prostate cancer according to histopathology of needle biopsy</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">923</enrollment>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>transrectal biopsy</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>transperineal biopsy</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>prostate biopsy</intervention_name>
      <description>Prostate biopsy by either transrectal or transperineal technique</description>
      <arm_group_label>transperineal biopsy</arm_group_label>
      <arm_group_label>transrectal biopsy</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All men who underwent a transrectal prostate biopsy between January 2017 and December 2018,&#xD;
          and/or a transperineal prostate biopsy between January 2021 and December 2022 in the&#xD;
          Urology department of MUMC+&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  men who underwent prostate biopsy between 2017-2018 (transrectal)&#xD;
  &#xD;
            -  men who underwent prostate biopsy between 2012-2022 (transperineal)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  positive urine culture before biopsy&#xD;
  &#xD;
            -  patients in the transrectal biopsy group who did not take the prescribed course of&#xD;
               antibiotic prophylaxis&#xD;
  &#xD;
            -  incomplete medical dossier where the occurrence of a complication could not be&#xD;
               assessed&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Maastricht University Medical Center</name>
        <address>
          <city>Maastricht</city>
          <zip>6229HX</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>prostate biopsy</keyword>
    <keyword>prostate cancer</keyword>
    <keyword>transperineal</keyword>
    <keyword>transrectal</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>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06027203
  org study id: MUMC-Pbx23
  nct id: NCT06027203
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background: Prostate biopsies are essential to diagnose prostate cancer (PCa). Transrectal
        prostate biopsies (TR-PB) are commonly performed, however disadvantages include the
        requirement of antibiotic prophylaxis (AP) and higher complication rates than transperineal
        prostate biopsies (TP-PB). Guidelines still recommend the use of AP for TP-PB due to the
        limited evidence regarding complication rates after their omission. However, the rising rates
        of antibiotic resistance is of concern. The aim of this study was to compare the complication
        and detection rates of freehand TP-PB without AP versus TR-PB with AP.
  
        Methods: This single center retrospective study was performed in an academic hospital. TP-PB
        were introduced in 2019 and implemented as the main technique by late 2020. To compare the
        two techniques, data was collected for freehand TR-PB with AP between 2017-2018 and freehand
        TP-PB without AP between 2021-2022. The data from 2019 and 2020 were excluded to rule out the
        effects of the initial learning curve during the transition period. Primary outcome measure
        was post-biopsy complications occurring within 2 weeks, focusing on infectious complications.
        Secondary outcome measures were detection rates and upgrading/reclassification in the repeat
        biopsy in active surveillance (AS). Statistical analysis was performed using a Fisher exact
        or Chi-Squared test.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Complications
  time frame: 2 weeks
  description: Urinary tract infections, urinary retention, hematuria
  measure: Detection rate
  time frame: 2 weeks
  description: Chance of detecting prostate cancer according to histopathology of needle biopsy
  arm group label: transrectal biopsy
  arm group label: transperineal biopsy
  intervention type: Procedure
  intervention name: prostate biopsy
  description: Prostate biopsy by either transrectal or transperineal technique
  arm group label: transperineal biopsy
  arm group label: transrectal biopsy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms
  sharing ipd: Undecided