<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/NCT04501055</url>
  </required_header>
  <id_info>
    <org_study_id>APROPOS-01</org_study_id>
    <nct_id>NCT04501055</nct_id>
  </id_info>
  <brief_title>Anesthesia in PROstate Biopsy Pain Obstruction Study</brief_title>
  <acronym>APROPOS</acronym>
  <official_title>A Prospective Multicenter Randomized Controlled Trial Assessing Whether the Perineal Nerve Block Approach is Better Than the Periprostatic Block for the Pain Control in Men Who Undergo Transperineal Prostate Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai East Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shi Shi Municipal General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>People's Hospital of Yiyuan County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of University of Science and Technology of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guang'an people's hospital of Sichuan province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai East Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a multicentre randomized controlled trial in comparison of the perineal nerve block&#xD;
      approach between the periprostatic block in the pain control in men undergo a transperineal&#xD;
      prostate biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a prospective, multicentre, randomized controlled study in which all men plan&#xD;
      to undergo a transperineal prostate biopsy. This study aims to determine whether the perineal&#xD;
      nerve block approach is better than the periprostatic block in the pain control in men&#xD;
      undergo a transperineal prostate biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Actual">July 27, 2022</completion_date>
  <primary_completion_date type="Actual">July 20, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The participant, the investigator and the outcomes assessor were all masked. Only the care provider who performed the anaesthesia were not blinded but they were not involved in the subsequent prostate biopsy, pain assessment, data collection and data analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The pain of the biopsy procedure</measure>
    <time_frame>within10 minutes after the prostate biopsy</time_frame>
    <description>The pain will be measured by numerical rating scale（NRS), which distributed from 0 to 10. 0 represents no pain, and 10 represents the worst pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The pain in 1,6, and 12 hours after the biopsy</measure>
    <time_frame>1,6, and 12 hours after the biopsy</time_frame>
    <description>The pain in 1,6, and 12 hours will be measured by numerical rating scale（NRS), which distributed from 0 to 10. 0 represents no pain, and 10 represents the worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure during biopsy procedure</measure>
    <time_frame>During the biopsy procedure</time_frame>
    <description>The changes will be measured and recorded by multi-parameter monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate during biopsy procedure</measure>
    <time_frame>During the biopsy procedure</time_frame>
    <description>The changes will be measured and recorded by multi-parameter monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in breath rate during biopsy procedure</measure>
    <time_frame>During the biopsy procedure</time_frame>
    <description>The changes will be measured and recorded by multi-parameter monitoring</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The detection rate for prostate cancer</measure>
    <time_frame>within 1 month after the biopsy</time_frame>
    <description>The detection rate for any of the prostate cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The detection rate for clinically significant prostate cancer</measure>
    <time_frame>within 1 month after the biopsy</time_frame>
    <description>The detection rate for prostate cancer with a ISUP&gt;2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>External manifestation of pain</measure>
    <time_frame>10 minutes within biopsy</time_frame>
    <description>A questionnaire with five items: the degree of facial expression (0 for no particular expression or smile; 1 for an occasional grimace or frown, a withdrawn expression, or a disinterested expression; 2 for frequent or constant quivering chin or a clenched jaw), the degree of activity (0 for lying quietly or being in a normal position, 1 for slight contractions of the hip muscles or slight movements of hip, 2 for severe contractions of the hip or lifting the hip out of the bed), the degree of voice expression (0 for quiet or normal communication, 1 for an occasional moan or weeping sound, 2 for constant moaning or sobbing and screaming), the degree of pacification (0 for being peaceful and not requiring pacification, 1 for being able to be comforted easily, 2 for being difficult to comfort) and the degree of cooperation (0 for being calm and cooperative, 1 for language resistance, 2 for body resistance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anaesthesia satisfaction</measure>
    <time_frame>24 hours after the biopsy</time_frame>
    <description>A questionnaire with five items :whether the pain during the biopsy was less severe than expected (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe than expected); whether the pain after anaesthesia was less severe than the pain during anaesthesia (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe); weather the patient is satisfied with the overall feeling of the biopsy (scores from 0 to 10, where 0 represents the highest level of satisfaction and 10 represents the lowest level of satisfaction); whether the patient would recommend this type of biopsy to other patients (scores from 0 to 10, where 0 represents they would highly recommend it and 10 represents they would definitely not recommend it); and whether the patient would still want to choose this way if they have to undergo another biopsy (scores from 0 to 10, where 0 represents very willing to choose it and 10 represents extreme reluctance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event</measure>
    <time_frame>Within 1 week after the biopsy</time_frame>
    <description>Any of the adverse events during the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of biopsy cores</measure>
    <time_frame>10 minutes within biopsy</time_frame>
    <description>The number of biopsy cores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The location of each biopsy core</measure>
    <time_frame>10 minutes within biopsy</time_frame>
    <description>The location of each biopsy core</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prostate volume</measure>
    <time_frame>within 3 months before the biopsy procedure</time_frame>
    <description>The prostate volume will be measured by MRI before biopsy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">192</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Perineal nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Man receive the perineal nerve block before under the transperineal prostate biopsy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Periprostatic block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Man receive the periprostatic block before under the transperineal prostate biopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>perineal nerve block</intervention_name>
    <description>An anesthesia method to block perineal nerve</description>
    <arm_group_label>Perineal nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>periprostatic block</intervention_name>
    <description>An anesthesia method to block periprostate</description>
    <arm_group_label>Periprostatic block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 18 and 80 years old&#xD;
&#xD;
          2. a PSA level of 4 - 20 ng/ml, and/or suspicious rectal examination findings;&#xD;
&#xD;
          3. fully understand the clinical trial protocol and sign the informed consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. local anesthetic allergy patients;&#xD;
&#xD;
          2. symptomatic acute or chronic inflammation of the prostate;&#xD;
&#xD;
          3. cannot tolerate prostate biopsy or has contraindication to biopsy;&#xD;
&#xD;
          4. patients judged by the investigator to be unsuitable to participate in the clinical&#xD;
             trial;&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haifeng Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai East Hospital,Tongji University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai East Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>transperineal prostate biopsy</keyword>
  <keyword>perineal nerve block</keyword>
  <keyword>periprostatic block</keyword>
  <keyword>anesthesia</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>Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will become available after publication with no end date</ipd_time_frame>
  </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/NCT04501055
org study id: APROPOS-01
nct id: NCT04501055
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a multicentre randomized controlled trial in comparison of the perineal nerve block
      approach between the periprostatic block in the pain control in men undergo a transperineal
      prostate biopsy.
This trial is a prospective, multicentre, randomized controlled study in which all men plan
      to undergo a transperineal prostate biopsy. This study aims to determine whether the perineal
      nerve block approach is better than the periprostatic block in the pain control in men
      undergo a transperineal prostate biopsy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The participant, the investigator and the outcomes assessor were all masked. Only the care provider who performed the anaesthesia were not blinded but they were not involved in the subsequent prostate biopsy, pain assessment, data collection and data analysis.
measure: The pain of the biopsy procedure
time frame: within10 minutes after the prostate biopsy
description: The pain will be measured by numerical rating scale（NRS), which distributed from 0 to 10. 0 represents no pain, and 10 represents the worst pain imaginable.
measure: The pain in 1,6, and 12 hours after the biopsy
time frame: 1,6, and 12 hours after the biopsy
description: The pain in 1,6, and 12 hours will be measured by numerical rating scale（NRS), which distributed from 0 to 10. 0 represents no pain, and 10 represents the worst pain imaginable.
measure: Changes in blood pressure during biopsy procedure
time frame: During the biopsy procedure
description: The changes will be measured and recorded by multi-parameter monitoring
measure: Changes in heart rate during biopsy procedure
time frame: During the biopsy procedure
description: The changes will be measured and recorded by multi-parameter monitoring
measure: Changes in breath rate during biopsy procedure
time frame: During the biopsy procedure
description: The changes will be measured and recorded by multi-parameter monitoring
measure: The detection rate for prostate cancer
time frame: within 1 month after the biopsy
description: The detection rate for any of the prostate cancer
measure: The detection rate for clinically significant prostate cancer
time frame: within 1 month after the biopsy
description: The detection rate for prostate cancer with a ISUP>2
measure: External manifestation of pain
time frame: 10 minutes within biopsy
description: A questionnaire with five items: the degree of facial expression (0 for no particular expression or smile; 1 for an occasional grimace or frown, a withdrawn expression, or a disinterested expression; 2 for frequent or constant quivering chin or a clenched jaw), the degree of activity (0 for lying quietly or being in a normal position, 1 for slight contractions of the hip muscles or slight movements of hip, 2 for severe contractions of the hip or lifting the hip out of the bed), the degree of voice expression (0 for quiet or normal communication, 1 for an occasional moan or weeping sound, 2 for constant moaning or sobbing and screaming), the degree of pacification (0 for being peaceful and not requiring pacification, 1 for being able to be comforted easily, 2 for being difficult to comfort) and the degree of cooperation (0 for being calm and cooperative, 1 for language resistance, 2 for body resistance).
measure: Anaesthesia satisfaction
time frame: 24 hours after the biopsy
description: A questionnaire with five items :whether the pain during the biopsy was less severe than expected (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe than expected); whether the pain after anaesthesia was less severe than the pain during anaesthesia (scores from 0 to 10, where 0 represents far less severe and 10 represents far more severe); weather the patient is satisfied with the overall feeling of the biopsy (scores from 0 to 10, where 0 represents the highest level of satisfaction and 10 represents the lowest level of satisfaction); whether the patient would recommend this type of biopsy to other patients (scores from 0 to 10, where 0 represents they would highly recommend it and 10 represents they would definitely not recommend it); and whether the patient would still want to choose this way if they have to undergo another biopsy (scores from 0 to 10, where 0 represents very willing to choose it and 10 represents extreme reluctance).
measure: Adverse event
time frame: Within 1 week after the biopsy
description: Any of the adverse events during the trial
measure: The number of biopsy cores
time frame: 10 minutes within biopsy
description: The number of biopsy cores
measure: The location of each biopsy core
time frame: 10 minutes within biopsy
description: The location of each biopsy core
measure: Prostate volume
time frame: within 3 months before the biopsy procedure
description: The prostate volume will be measured by MRI before biopsy
arm group label: Perineal nerve block
arm group type: Experimental
description: Man receive the perineal nerve block before under the transperineal prostate biopsy
arm group label: Periprostatic block
arm group type: Active Comparator
description: Man receive the periprostatic block before under the transperineal prostate biopsy
intervention type: Behavioral
intervention name: perineal nerve block
description: An anesthesia method to block perineal nerve
arm group label: Perineal nerve block
intervention type: Behavioral
intervention name: periprostatic block
description: An anesthesia method to block periprostate
arm group label: Periprostatic block
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Haifeng Wang
role: Principal Investigator
affiliation: Shanghai East Hospital,Tongji University School of Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: Yes
ipd description: Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will become available after publication with no end date