<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/NCT03783741</url>
  </required_header>
  <id_info>
    <org_study_id>Prostate Biopsy Burden</org_study_id>
    <nct_id>NCT03783741</nct_id>
  </id_info>
  <brief_title>The Biopsychosocial Burden of Prostate Biopsy</brief_title>
  <official_title>The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campinas, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campinas, Brazil</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>
      Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA)&#xD;
      over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a&#xD;
      biopsy. Comprehensive validated questionnaires at TIME 0 (pre-biopsy), TIME 1 (before&#xD;
      diagnosis, 20 days after biopsy) and TIME 2 (after diagnosis, 40 days after biopsy) accessed&#xD;
      patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI),&#xD;
      hopelessness (BHS) and depression (BDI), added to the emotional thermometers including five&#xD;
      visual analog scales for distress, anxiety, depression, anger and need for help. Mann-Whitney&#xD;
      or Friedman tests were obtained among times and studied variables.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, longitudinal and observational study in which the sexually active patients&#xD;
      were evaluated in the Urology Department of the city of Paulínia, submitted to biopsy guided&#xD;
      by transrectal ultrasound after ethics committee approval (355.357).&#xD;
&#xD;
      Consecutive patients who were attended by urologist and present prostate cancer suspicions&#xD;
      (PSA&gt; 4 ng / dL and/or rectal examination (TR) were submitted a BXP. They were evaluated at&#xD;
      three different moments of the biopsy:&#xD;
&#xD;
        -  Seven days before the biopsy procedure (T0);&#xD;
&#xD;
        -  20 days after the biopsy, upon receiving the histopathological result, before becoming&#xD;
           aware of it (T1);&#xD;
&#xD;
        -  40 days after the biopsy, 20 days after being aware of the test result (T2). Sixty-one&#xD;
           consecutive patients were invited to participate in the study, 10 of them had no active&#xD;
           sexual life and 9 answered the questionnaires only at the first moment, were excluded;&#xD;
           47 responded at three times (T0, T1, and T2).&#xD;
&#xD;
      Validated instruments were applied - IIEF-5 (erectile function); - IPSS (voiding function); -&#xD;
      Beck scales - BAI (anxiety), BHS (hopelessness), BDI (depression); and - Emotional&#xD;
      thermometers.&#xD;
&#xD;
      The comparison among the moments (T0, T1, and T2) was performed through Friedman (analysis of&#xD;
      variance) for repeated measures with the variables transformed in stations. The comparison&#xD;
      between patients and variables was performed using the Mann-Whitney test. The sample power&#xD;
      was calculated and the level of significance considered was 5%.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Erectile Function</measure>
    <time_frame>Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)</time_frame>
    <description>International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Voiding Function</measure>
    <time_frame>Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)</time_frame>
    <description>International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Beck scale</measure>
    <time_frame>Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)</time_frame>
    <description>Beck Anxiety Index - BAI (0-63; higher worse)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional thermometers</measure>
    <time_frame>Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)</time_frame>
    <description>Thermometer score (range 0-10; higher worse)</description>
  </primary_outcome>
  <enrollment type="Actual">47</enrollment>
  <condition>Prostate Cancer</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Interview</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients who were attended by a urologist with prostate biopsy indication.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  prostate cancer suspicion (PSA &gt; 4 ng / dL, digital rectal examination)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not agree to participate&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Hospital das Clínicas Unicamp</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13083-887</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Naccarato AM, Reis LO, Matheus WE, Ferreira U, Denardi F. Barriers to prostate cancer screening: psychological aspects and descriptive variables---is there a correlation? Aging Male. 2011 Mar;14(1):66-71. doi: 10.3109/13685538.2010.522277. Epub 2010 Oct 12.</citation>
    <PMID>20937009</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
    <investigator_full_name>Leonardo Oliveira Reis</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>Biopsy</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>


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/NCT03783741
org study id: Prostate Biopsy Burden
nct id: NCT03783741
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA)
      over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a
      biopsy. Comprehensive validated questionnaires at TIME 0 (pre-biopsy), TIME 1 (before
      diagnosis, 20 days after biopsy) and TIME 2 (after diagnosis, 40 days after biopsy) accessed
      patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI),
      hopelessness (BHS) and depression (BDI), added to the emotional thermometers including five
      visual analog scales for distress, anxiety, depression, anger and need for help. Mann-Whitney
      or Friedman tests were obtained among times and studied variables.
A prospective, longitudinal and observational study in which the sexually active patients
      were evaluated in the Urology Department of the city of Paulínia, submitted to biopsy guided
      by transrectal ultrasound after ethics committee approval (355.357).

      Consecutive patients who were attended by urologist and present prostate cancer suspicions
      (PSA> 4 ng / dL and/or rectal examination (TR) were submitted a BXP. They were evaluated at
      three different moments of the biopsy:

        -  Seven days before the biopsy procedure (T0);

        -  20 days after the biopsy, upon receiving the histopathological result, before becoming
           aware of it (T1);

        -  40 days after the biopsy, 20 days after being aware of the test result (T2). Sixty-one
           consecutive patients were invited to participate in the study, 10 of them had no active
           sexual life and 9 answered the questionnaires only at the first moment, were excluded;
           47 responded at three times (T0, T1, and T2).

      Validated instruments were applied - IIEF-5 (erectile function); - IPSS (voiding function); -
      Beck scales - BAI (anxiety), BHS (hopelessness), BDI (depression); and - Emotional
      thermometers.

      The comparison among the moments (T0, T1, and T2) was performed through Friedman (analysis of
      variance) for repeated measures with the variables transformed in stations. The comparison
      between patients and variables was performed using the Mann-Whitney test. The sample power
      was calculated and the level of significance considered was 5%.
observational model: Cohort
time perspective: Prospective
measure: Erectile Function
time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
description: International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)
measure: Voiding Function
time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
description: International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)
measure: Beck scale
time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
description: Beck Anxiety Index - BAI (0-63; higher worse)
measure: Emotional thermometers
time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
description: Thermometer score (range 0-10; higher worse)
intervention type: Behavioral
intervention name: Questionnaire
description: Interview
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
facility: 
country: Brazil
citation: Naccarato AM, Reis LO, Matheus WE, Ferreira U, Denardi F. Barriers to prostate cancer screening: psychological aspects and descriptive variables---is there a correlation? Aging Male. 2011 Mar;14(1):66-71. doi: 10.3109/13685538.2010.522277. Epub 2010 Oct 12.
PMID: 20937009
responsible party type: Principal Investigator
investigator affiliation: University of Campinas, Brazil
investigator full name: Leonardo Oliveira Reis
investigator title: Professor
mesh term: Prostatic Neoplasms
sharing ipd: Undecided