Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-02-05 @ 12:44 PM
Study NCT ID:
NCT03790995
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2018-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9235}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-31', 'studyFirstSubmitDate': '2018-12-29', 'studyFirstSubmitQcDate': '2018-12-29', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global quality of life', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC C30 global quality of life, questionnaire'}, {'measure': 'Emotional quality of life', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC C30 emotional quality of life, questionnaire'}, {'measure': 'physical quality of life', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC C30 physical quality of life, questionnaire'}, {'measure': 'Cognitive quality of life', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC C30 cognitive quality of life, questionnaire'}, {'measure': 'Erectile function - IIEF 5', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'International Index of Erectile Function (IIEF-5), questionnaire'}, {'measure': 'Erectile function - sexual activity', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC PR25 sexual activity, questionnaire'}, {'measure': 'Erectile function - sexual functioning', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC PR25 sexual functioning, questionnaire'}, {'measure': 'Urinary function - Incontinence aid', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC PR25 incontinence aid, questionnaire'}, {'measure': 'Urinary function - urinary symptoms', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'EORTC PR25 urinary symptoms, questionnaire'}, {'measure': 'Urinary function - ICIQ', 'timeFrame': 'Longitudinal modelling over 24 months', 'description': 'International Consultation on Incontinence Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Robot assisted radical prostatectomy', 'RALP', 'RARP', 'High risk', 'Intermediate risk', 'Low risk', 'Urinary', 'Erectile', 'Quality of life', 'QoL', 'Post operation', 'functional outcomes', 'follow-up'], 'conditions': ['Prostate Cancer', 'Quality of Life', 'Erectile Function', 'Urinary Function']}, 'referencesModule': {'references': [{'pmid': '28743170', 'type': 'BACKGROUND', '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': '31100256', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBetween 2009 and 2016, 9235 patients were included in this patient registry.\n\nThe studied outcomes covered quality of life measures as well as variables covering urinary and erectile function.', 'detailedDescription': '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.\n\nTwenty-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.\n\nThese parameters increase the quality of data handling and database.\n\nThe 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.\n\nThe 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.\n\nThe 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).\n\nA 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from 90% of all Belgian robotic assisted radical prostatectomy centres between 2009 and 2016 with prostate cancer undergoing RALP. Patients reflect very well the Belgian prostate cancer patient population since 25 centres participated.\n\nNIHDI reimbursement criteria insured a high inclusion rate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with prostate cancer\n* Eligible to undergo RALP\n* RALP in one of the 25 participating centres\n\nExclusion Criteria:\n\n* iPSA \\> 100\n* Confirmed metastasis\n* invalid survival data\n* pT0\n* Missing nerve sparing details\n* Missing risk group'}, 'identificationModule': {'nctId': 'NCT03790995', 'briefTitle': 'Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'Be-RALP functioning and QoL'}}, 'armsInterventionsModule': {'armGroups': [{'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.\n\nBoth 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).', 'interventionNames': ['Procedure: Robot assisted laparoscopic prostatectomy']}, {'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.\n\nBoth 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).', 'interventionNames': ['Procedure: Robot assisted laparoscopic prostatectomy']}], 'interventions': [{'name': 'Robot assisted laparoscopic prostatectomy', 'type': 'PROCEDURE', 'otherNames': ['+- postoperative treatments'], 'armGroupLabels': ['High risk prostate cancer', 'Low - intermediate risk prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Algemeen Stedelijk Ziekenhuis Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '2610', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GZA ziekenhuizen - Campus Sint-Augustinus', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2930', 'city': 'Brasschaat', 'country': 'Belgium', 'facility': 'AZ Klina', 'geoPoint': {'lat': 51.2912, 'lon': 4.49182}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan Brugge-Oostende', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Lucas', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint-Pierre Bruxelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet Bruxelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Erasme Bruxelles', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1160', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHIREC', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9200', 'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'AZ Sint Blasius Dendermonde', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Jan Palfijn Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Maria Middelares Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Sint-Lucas Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '8500', 'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHR de la Citadelle Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'CHU Ambroise Paré Mons', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': '8400', 'city': 'Ostend', 'country': 'Belgium', 'facility': 'AZ Damiaan', 'geoPoint': {'lat': 51.21551, 'lon': 2.927}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '1180', 'city': 'Uccle', 'country': 'Belgium', 'facility': "Cliniques de l'Europe Bruxelles", 'geoPoint': {'lat': 50.80225, 'lon': 4.33943}}, {'zip': '1800', 'city': 'Vilvoorde', 'country': 'Belgium', 'facility': 'AZ Jan Portaels', 'geoPoint': {'lat': 50.92814, 'lon': 4.42938}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Cliniques Universitaires de Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '9620', 'city': 'Zottegem', 'country': 'Belgium', 'facility': 'AZ Sint-Elisabeth Zottegem', 'geoPoint': {'lat': 50.86955, 'lon': 3.81052}}], 'overallOfficials': [{'name': 'Steven Joniau, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, KU Leuven, Leuven Belgium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'After discussion with the board on the requested data, possibly aggregated data can be send to the requesting party.\n\nNo individual patient data can be send due to privacy concerns and local legislations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Belgian Cancer Registry', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wout Devlies', 'investigatorAffiliation': 'KU Leuven'}}}}