Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP
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)
1 other identifier
observational
9,235
1 country
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 29, 2018
CompletedFirst Posted
Study publicly available on registry
January 2, 2019
CompletedJanuary 3, 2019
December 1, 2018
6.3 years
December 29, 2018
December 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Global quality of life
EORTC C30 global quality of life, questionnaire
Longitudinal modelling over 24 months
Emotional quality of life
EORTC C30 emotional quality of life, questionnaire
Longitudinal modelling over 24 months
physical quality of life
EORTC C30 physical quality of life, questionnaire
Longitudinal modelling over 24 months
Cognitive quality of life
EORTC C30 cognitive quality of life, questionnaire
Longitudinal modelling over 24 months
Erectile function - IIEF 5
International Index of Erectile Function (IIEF-5), questionnaire
Longitudinal modelling over 24 months
Erectile function - sexual activity
EORTC PR25 sexual activity, questionnaire
Longitudinal modelling over 24 months
Erectile function - sexual functioning
EORTC PR25 sexual functioning, questionnaire
Longitudinal modelling over 24 months
Urinary function - Incontinence aid
EORTC PR25 incontinence aid, questionnaire
Longitudinal modelling over 24 months
Urinary function - urinary symptoms
EORTC PR25 urinary symptoms, questionnaire
Longitudinal modelling over 24 months
Urinary function - ICIQ
International Consultation on Incontinence Questionnaire
Longitudinal modelling over 24 months
Study Arms (2)
High risk prostate cancer
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).
Low - intermediate risk prostate cancer
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).
Interventions
Eligibility Criteria
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. NIHDI reimbursement criteria insured a high inclusion rate.
You may qualify if:
- Diagnosed with prostate cancer
- Eligible to undergo RALP
- RALP in one of the 25 participating centres
You may not qualify if:
- iPSA \> 100
- Confirmed metastasis
- invalid survival data
- pT0
- Missing nerve sparing details
- Missing risk group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
- Belgian Cancer Registrycollaborator
Study Sites (25)
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, 9300, Belgium
Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove
Aalst, 9300, Belgium
GZA ziekenhuizen - Campus Sint-Augustinus
Antwerp, 2610, Belgium
AZ Klina
Brasschaat, 2930, Belgium
AZ Sint-Jan Brugge-Oostende
Bruges, 8000, Belgium
AZ Sint-Lucas
Bruges, 8000, Belgium
CHU Saint-Pierre Bruxelles
Brussels, 1000, Belgium
Institut Jules Bordet Bruxelles
Brussels, 1000, Belgium
Hôpital Erasme Bruxelles
Brussels, 1070, Belgium
CHIREC
Brussels, 1160, Belgium
AZ Sint Blasius Dendermonde
Dendermonde, 9200, Belgium
AZ Jan Palfijn Gent
Ghent, 9000, Belgium
AZ Maria Middelares Gent
Ghent, 9000, Belgium
AZ Sint-Lucas Gent
Ghent, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
Universitaire ziekenhuizen Leuven
Leuven, 3000, Belgium
CHR de la Citadelle Liège
Liège, 4000, Belgium
CHU Ambroise Paré Mons
Mons, 7000, Belgium
AZ Damiaan
Ostend, 8400, Belgium
AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen
Roeselare, 8800, Belgium
Cliniques de l'Europe Bruxelles
Uccle, 1180, Belgium
AZ Jan Portaels
Vilvoorde, 1800, Belgium
Cliniques Universitaires de Mont-Godinne
Yvoir, 5530, Belgium
AZ Sint-Elisabeth Zottegem
Zottegem, 9620, Belgium
Related Publications (2)
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: 28743170BACKGROUNDTosco 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: 31100256BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Joniau, Professor
Department of Urology, KU Leuven, Leuven Belgium
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 29, 2018
First Posted
January 2, 2019
Study Start
October 1, 2009
Primary Completion
February 1, 2016
Study Completion
February 1, 2018
Last Updated
January 3, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share
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