<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/NCT03790995</url>
  </required_header>
  <id_info>
    <org_study_id>Be-RALP functioning and QoL</org_study_id>
    <nct_id>NCT03790995</nct_id>
  </id_info>
  <brief_title>Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP</brief_title>
  <official_title>Intermediate Term Functional Outcomes and Quality of Life in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by Robot-assisted Laparoscopic Prostatectomy (RALP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Belgian Cancer Registry</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</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 Be-RALP database is Belgian prospective multicenter database governed by the Belgian&#xD;
      cancer registry. This database investigates the status after robot assisted laparoscopic&#xD;
      prostatectomy (RALP) in prostate cancer patients. It was established by a collaboration&#xD;
      between the Belgian association of Urology (BAU), the National Institute for Health and&#xD;
      Disability Insurance (NIHDI) and the Belgian cancer registry.&#xD;
&#xD;
      Between 2009 and 2016, 9235 patients were included in this patient registry.&#xD;
&#xD;
      The studied outcomes covered quality of life measures as well as variables covering urinary&#xD;
      and erectile function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Be-RALP database is Belgian prospective multicenter database governed by the Belgian&#xD;
      cancer registry. This was established by a collaboration between the Belgian association of&#xD;
      Urology (BAU), the National Institute for Health and Disability Insurance (NIHDI) and the&#xD;
      Belgian cancer registry.&#xD;
&#xD;
      Twenty-five centres, on average 90% of all Belgian robotic centres, collected prospective&#xD;
      data of 9235 patients from October 2009 until February 2016. These data is collected by local&#xD;
      data managers or physicians and was required to receive reimbursion from the NIHDI for the&#xD;
      disposables used during robot surgery. After filling in the data by the local datamanagers,&#xD;
      the data is centralised. In Brussels the data is protected and further used by data managers&#xD;
      and statisticians. In this system in-and output of data is strictly separated. Patient data&#xD;
      is encoded to ensure absolute privacy. Then the data is checked upon correctness by using&#xD;
      random checks. Data is completed where necessary.&#xD;
&#xD;
      These parameters increase the quality of data handling and database.&#xD;
&#xD;
      The final database consists of baseline pre-, per- and postoperative data as well as four&#xD;
      standardised follow-up registrations (on 1, 3, 12 and 24 months), with follow-up data still&#xD;
      being collected. In each follow-up registration, functional parameters and quality of life&#xD;
      are re-assessed together with postoperative treatment status and PSA.&#xD;
&#xD;
      The Be-RALP database collected patient details of 9235 patients treated by RARP between 2009&#xD;
      and 2016. Patients with macro metastasis and initial PSA values higher than 100 (probable&#xD;
      undetected micro metastasis) were excluded for this study, as well as all pT0, patients with&#xD;
      surgery after the closing date and patients with invalid survival data. Further exclusion of&#xD;
      patients with missing values for nerve sparing, extend of nerve sparing and risk category&#xD;
      resulted in a group of 8306 patients.&#xD;
&#xD;
      The selected outcomes covered in the database consist of quality of life measures (European&#xD;
      Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global, physical, emotional&#xD;
      and cognitive) as well as variables covering urinary (Incontinence Modular&#xD;
      Questionnaire-Urinary Incontinence: ICIQ, EORTC QLQ-PR25 urinary symptoms, incontinence aid)&#xD;
      and erectile function (International Index of Erectile Function: IIEF, EORTC QLQ-PR25 sexual&#xD;
      activity and sexual functioning).&#xD;
&#xD;
      A 1:1 matching between high and low-intermediate prostate cancer will be performed.&#xD;
      Afterwards, longitudinal mixed models will quantify the relation between the explanatory&#xD;
      variables follow-up time, risk group (high vs. low-intermediate) and postoperative treatment&#xD;
      (postoperative radiotherapy (RT) and/or androgen deprivation therapy (ADT): yes vs. no) and&#xD;
      the outcomes erectile- and urinary function as well as Quality of Life. All analysis will be&#xD;
      performed using the statistical analysis software (SAS system), version 9.3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2009</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Global quality of life</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC C30 global quality of life, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emotional quality of life</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC C30 emotional quality of life, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physical quality of life</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC C30 physical quality of life, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive quality of life</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC C30 cognitive quality of life, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Erectile function - IIEF 5</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>International Index of Erectile Function (IIEF-5), questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Erectile function - sexual activity</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC PR25 sexual activity, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Erectile function - sexual functioning</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC PR25 sexual functioning, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary function - Incontinence aid</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC PR25 incontinence aid, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary function - urinary symptoms</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>EORTC PR25 urinary symptoms, questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary function - ICIQ</measure>
    <time_frame>Longitudinal modelling over 24 months</time_frame>
    <description>International Consultation on Incontinence Questionnaire</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">9235</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Quality of Life</condition>
  <condition>Erectile Function</condition>
  <condition>Urinary Function</condition>
  <arm_group>
    <arm_group_label>High risk prostate cancer</arm_group_label>
    <description>Patients with initial cT2c-3-4, cN +, Gleason score (GS) more than 7 or PSA &gt; 20ng/mL were labelled as high-risk prostate cancer.&#xD;
Both groups received robot assisted laparoscopic prostatectomy. Matching across age (continuous), year of surgery (2009+2010, 2011, 2012, 2013, 2014, 2015+2016), nerve sparing (bilateral, unilateral or no nerve sparing) and centre size (continuous). 1:1 coarsened exact matching. Continuous variables are temporarily coarsened as followed: age (&lt;55, 55-&lt;65, 65-&lt;75, 75+) and centre size (&lt;50, 50-&lt;100, 100+ cases/year).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low - intermediate risk prostate cancer</arm_group_label>
    <description>Initial PSA levels less or equal than 20 ng/mL with GS of 7 or less and cT1-2a-2b, 2 were labelled as low and intermediate risk prostate cancer and served as a control group.&#xD;
Both groups received robot assisted laparoscopic prostatectomy. Matching across age (continuous), year of surgery (2009+2010, 2011, 2012, 2013, 2014, 2015+2016), nerve sparing (bilateral, unilateral or no nerve sparing) and centre size (continuous). 1:1 coarsened exact matching. Continuous variables are temporarily coarsened as followed: age (&lt;55, 55-&lt;65, 65-&lt;75, 75+) and centre size (&lt;50, 50-&lt;100, 100+ cases/year).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Robot assisted laparoscopic prostatectomy</intervention_name>
    <arm_group_label>High risk prostate cancer</arm_group_label>
    <arm_group_label>Low - intermediate risk prostate cancer</arm_group_label>
    <other_name>+- postoperative treatments</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from 90% of all Belgian robotic assisted radical prostatectomy centres between&#xD;
        2009 and 2016 with prostate cancer undergoing RALP. Patients reflect very well the Belgian&#xD;
        prostate cancer patient population since 25 centres participated.&#xD;
&#xD;
        NIHDI reimbursement criteria insured a high inclusion rate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with prostate cancer&#xD;
&#xD;
          -  Eligible to undergo RALP&#xD;
&#xD;
          -  RALP in one of the 25 participating centres&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  iPSA &gt; 100&#xD;
&#xD;
          -  Confirmed metastasis&#xD;
&#xD;
          -  invalid survival data&#xD;
&#xD;
          -  pT0&#xD;
&#xD;
          -  Missing nerve sparing details&#xD;
&#xD;
          -  Missing risk group&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Joniau, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Urology, KU Leuven, Leuven Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Algemeen Stedelijk Ziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GZA ziekenhuizen - Campus Sint-Augustinus</name>
      <address>
        <city>Antwerp</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Klina</name>
      <address>
        <city>Brasschaat</city>
        <zip>2930</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan Brugge-Oostende</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Lucas</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Pierre Bruxelles</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet Bruxelles</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Erasme Bruxelles</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHIREC</name>
      <address>
        <city>Brussels</city>
        <zip>1160</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Blasius Dendermonde</name>
      <address>
        <city>Dendermonde</city>
        <zip>9200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Jan Palfijn Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Lucas Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire ziekenhuizen Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR de la Citadelle Liège</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Ambroise Paré Mons</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Damiaan</name>
      <address>
        <city>Oostende</city>
        <zip>8400</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques de l'Europe Bruxelles</name>
      <address>
        <city>Uccle</city>
        <zip>1180</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Jan Portaels</name>
      <address>
        <city>Vilvoorde</city>
        <zip>1800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires de Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Elisabeth Zottegem</name>
      <address>
        <city>Zottegem</city>
        <zip>9620</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://kankerregister.org/default.aspx?lang=EN</url>
    <description>Overview activities cancer registry</description>
  </link>
  <link>
    <url>http://www.ejustice.just.fgov.be/doc/rech_n.htm</url>
    <description>Legal base upon which usage and collection of data is explained</description>
  </link>
  <reference>
    <citation>Albisinni S, Joniau S, Quackels T, De Coster G, Dekuyper P, Van Cleynenbreugel B, Van Damme N, Van Eycken E, Ameye F, Roumeguere T; Be-RALP Registry (Belgian Robotic-Assisted Laparoscopic Prostatectomy Registry). Current trends in patient enrollment for robotic-assisted laparoscopic prostatectomy in Belgium. Cancer. 2017 Nov 1;123(21):4139-4146. doi: 10.1002/cncr.30874. Epub 2017 Jul 25.</citation>
    <PMID>28743170</PMID>
  </reference>
  <reference>
    <citation>Tosco L, De Coster G, Roumeguere T, Everaerts W, Quackels T, Dekuyper P, Van Cleynenbreugel B, Van Damme N, Van Eycken E, Ameye F, Joniau S; Be RALP the Belgian RALP consortium. Development and External Validation of Nomograms To Predict Adverse Pathological Characteristics After Robotic Prostatectomy: Results of a Prospective, Multi-institutional, Nationwide series. Eur Urol Oncol. 2018 Sep;1(4):338-345. doi: 10.1016/j.euo.2018.04.008. Epub 2018 Jun 7.</citation>
    <PMID>31100256</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Wout Devlies</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Prostate cancer</keyword>
  <keyword>Robot assisted radical prostatectomy</keyword>
  <keyword>RALP</keyword>
  <keyword>RARP</keyword>
  <keyword>High risk</keyword>
  <keyword>Intermediate risk</keyword>
  <keyword>Low risk</keyword>
  <keyword>Urinary</keyword>
  <keyword>Erectile</keyword>
  <keyword>Quality of life</keyword>
  <keyword>QoL</keyword>
  <keyword>Post operation</keyword>
  <keyword>functional outcomes</keyword>
  <keyword>follow-up</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>No</sharing_ipd>
    <ipd_description>After discussion with the board on the requested data, possibly aggregated data can be send to the requesting party.&#xD;
No individual patient data can be send due to privacy concerns and local legislations</ipd_description>
  </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/NCT03790995
org study id: Be-RALP functioning and QoL
nct id: NCT03790995
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Be-RALP database is Belgian prospective multicenter database governed by the Belgian
      cancer registry. This database investigates the status after robot assisted laparoscopic
      prostatectomy (RALP) in prostate cancer patients. It was established by a collaboration
      between the Belgian association of Urology (BAU), the National Institute for Health and
      Disability Insurance (NIHDI) and the Belgian cancer registry.

      Between 2009 and 2016, 9235 patients were included in this patient registry.

      The studied outcomes covered quality of life measures as well as variables covering urinary
      and erectile function.
The Be-RALP database is Belgian prospective multicenter database governed by the Belgian
      cancer registry. This was established by a collaboration between the Belgian association of
      Urology (BAU), the National Institute for Health and Disability Insurance (NIHDI) and the
      Belgian cancer registry.

      Twenty-five centres, on average 90% of all Belgian robotic centres, collected prospective
      data of 9235 patients from October 2009 until February 2016. These data is collected by local
      data managers or physicians and was required to receive reimbursion from the NIHDI for the
      disposables used during robot surgery. After filling in the data by the local datamanagers,
      the data is centralised. In Brussels the data is protected and further used by data managers
      and statisticians. In this system in-and output of data is strictly separated. Patient data
      is encoded to ensure absolute privacy. Then the data is checked upon correctness by using
      random checks. Data is completed where necessary.

      These parameters increase the quality of data handling and database.

      The final database consists of baseline pre-, per- and postoperative data as well as four
      standardised follow-up registrations (on 1, 3, 12 and 24 months), with follow-up data still
      being collected. In each follow-up registration, functional parameters and quality of life
      are re-assessed together with postoperative treatment status and PSA.

      The Be-RALP database collected patient details of 9235 patients treated by RARP between 2009
      and 2016. Patients with macro metastasis and initial PSA values higher than 100 (probable
      undetected micro metastasis) were excluded for this study, as well as all pT0, patients with
      surgery after the closing date and patients with invalid survival data. Further exclusion of
      patients with missing values for nerve sparing, extend of nerve sparing and risk category
      resulted in a group of 8306 patients.

      The selected outcomes covered in the database consist of quality of life measures (European
      Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 global, physical, emotional
      and cognitive) as well as variables covering urinary (Incontinence Modular
      Questionnaire-Urinary Incontinence: ICIQ, EORTC QLQ-PR25 urinary symptoms, incontinence aid)
      and erectile function (International Index of Erectile Function: IIEF, EORTC QLQ-PR25 sexual
      activity and sexual functioning).

      A 1:1 matching between high and low-intermediate prostate cancer will be performed.
      Afterwards, longitudinal mixed models will quantify the relation between the explanatory
      variables follow-up time, risk group (high vs. low-intermediate) and postoperative treatment
      (postoperative radiotherapy (RT) and/or androgen deprivation therapy (ADT): yes vs. no) and
      the outcomes erectile- and urinary function as well as Quality of Life. All analysis will be
      performed using the statistical analysis software (SAS system), version 9.3.
observational model: Case-Control
time perspective: Prospective
measure: Global quality of life
time frame: Longitudinal modelling over 24 months
description: EORTC C30 global quality of life, questionnaire
measure: Emotional quality of life
time frame: Longitudinal modelling over 24 months
description: EORTC C30 emotional quality of life, questionnaire
measure: physical quality of life
time frame: Longitudinal modelling over 24 months
description: EORTC C30 physical quality of life, questionnaire
measure: Cognitive quality of life
time frame: Longitudinal modelling over 24 months
description: EORTC C30 cognitive quality of life, questionnaire
measure: Erectile function - IIEF 5
time frame: Longitudinal modelling over 24 months
description: International Index of Erectile Function (IIEF-5), questionnaire
measure: Erectile function - sexual activity
time frame: Longitudinal modelling over 24 months
description: EORTC PR25 sexual activity, questionnaire
measure: Erectile function - sexual functioning
time frame: Longitudinal modelling over 24 months
description: EORTC PR25 sexual functioning, questionnaire
measure: Urinary function - Incontinence aid
time frame: Longitudinal modelling over 24 months
description: EORTC PR25 incontinence aid, questionnaire
measure: Urinary function - urinary symptoms
time frame: Longitudinal modelling over 24 months
description: EORTC PR25 urinary symptoms, questionnaire
measure: Urinary function - ICIQ
time frame: Longitudinal modelling over 24 months
description: International Consultation on Incontinence Questionnaire
arm group label: High risk prostate cancer
description: Patients with initial cT2c-3-4, cN +, Gleason score (GS) more than 7 or PSA > 20ng/mL were labelled as high-risk prostate cancer.
Both groups received robot assisted laparoscopic prostatectomy. Matching across age (continuous), year of surgery (2009+2010, 2011, 2012, 2013, 2014, 2015+2016), nerve sparing (bilateral, unilateral or no nerve sparing) and centre size (continuous). 1:1 coarsened exact matching. Continuous variables are temporarily coarsened as followed: age (<55, 55-<65, 65-<75, 75+) and centre size (<50, 50-<100, 100+ cases/year).
arm group label: Low - intermediate risk prostate cancer
description: Initial PSA levels less or equal than 20 ng/mL with GS of 7 or less and cT1-2a-2b, 2 were labelled as low and intermediate risk prostate cancer and served as a control group.
Both groups received robot assisted laparoscopic prostatectomy. Matching across age (continuous), year of surgery (2009+2010, 2011, 2012, 2013, 2014, 2015+2016), nerve sparing (bilateral, unilateral or no nerve sparing) and centre size (continuous). 1:1 coarsened exact matching. Continuous variables are temporarily coarsened as followed: age (<55, 55-<65, 65-<75, 75+) and centre size (<50, 50-<100, 100+ cases/year).
intervention type: Procedure
intervention name: Robot assisted laparoscopic prostatectomy
arm group label: High risk prostate cancer
arm group label: Low - intermediate risk prostate cancer
other name: +- postoperative treatments
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Steven Joniau, Professor
role: Principal Investigator
affiliation: Department of Urology, KU Leuven, Leuven Belgium
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country: Belgium
url: http://kankerregister.org/default.aspx?lang=EN
description: Overview activities cancer registry
url: http://www.ejustice.just.fgov.be/doc/rech_n.htm
description: Legal base upon which usage and collection of data is explained
citation: Albisinni S, Joniau S, Quackels T, De Coster G, Dekuyper P, Van Cleynenbreugel B, Van Damme N, Van Eycken E, Ameye F, Roumeguere T; Be-RALP Registry (Belgian Robotic-Assisted Laparoscopic Prostatectomy Registry). Current trends in patient enrollment for robotic-assisted laparoscopic prostatectomy in Belgium. Cancer. 2017 Nov 1;123(21):4139-4146. doi: 10.1002/cncr.30874. Epub 2017 Jul 25.
PMID: 28743170
citation: Tosco L, De Coster G, Roumeguere T, Everaerts W, Quackels T, Dekuyper P, Van Cleynenbreugel B, Van Damme N, Van Eycken E, Ameye F, Joniau S; Be RALP the Belgian RALP consortium. Development and External Validation of Nomograms To Predict Adverse Pathological Characteristics After Robotic Prostatectomy: Results of a Prospective, Multi-institutional, Nationwide series. Eur Urol Oncol. 2018 Sep;1(4):338-345. doi: 10.1016/j.euo.2018.04.008. Epub 2018 Jun 7.
PMID: 31100256
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Wout Devlies
investigator title: Principal Investigator
mesh term: Prostatic Neoplasms
sharing ipd: No
ipd description: After discussion with the board on the requested data, possibly aggregated data can be send to the requesting party.
No individual patient data can be send due to privacy concerns and local legislations