Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP
- Conditions
- Prostate CancerQuality of LifeErectile FunctionUrinary Function
- Interventions
- Procedure: Robot assisted laparoscopic prostatectomy
- Registration Number
- NCT03790995
- Lead Sponsor
- KU Leuven
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 9235
- Diagnosed with prostate cancer
- Eligible to undergo RALP
- RALP in one of the 25 participating centres
- iPSA > 100
- Confirmed metastasis
- invalid survival data
- pT0
- Missing nerve sparing details
- Missing risk group
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Low - intermediate risk prostate cancer Robot assisted laparoscopic prostatectomy 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). High risk prostate cancer Robot assisted laparoscopic prostatectomy 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).
- Primary Outcome Measures
Name Time Method Cognitive quality of life Longitudinal modelling over 24 months EORTC C30 cognitive quality of life, questionnaire
Erectile function - IIEF 5 Longitudinal modelling over 24 months International Index of Erectile Function (IIEF-5), questionnaire
Erectile function - sexual activity Longitudinal modelling over 24 months EORTC PR25 sexual activity, questionnaire
Erectile function - sexual functioning Longitudinal modelling over 24 months EORTC PR25 sexual functioning, questionnaire
Urinary function - ICIQ Longitudinal modelling over 24 months International Consultation on Incontinence Questionnaire
Emotional quality of life Longitudinal modelling over 24 months EORTC C30 emotional quality of life, questionnaire
Urinary function - Incontinence aid Longitudinal modelling over 24 months EORTC PR25 incontinence aid, questionnaire
Urinary function - urinary symptoms Longitudinal modelling over 24 months EORTC PR25 urinary symptoms, questionnaire
Global quality of life Longitudinal modelling over 24 months EORTC C30 global quality of life, questionnaire
physical quality of life Longitudinal modelling over 24 months EORTC C30 physical quality of life, questionnaire
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
Institut Jules Bordet Bruxelles
🇧🇪Brussels, Belgium
AZ Damiaan
🇧🇪Oostende, Belgium
Cliniques de l'Europe Bruxelles
🇧🇪Uccle, Belgium
Algemeen Stedelijk Ziekenhuis Aalst
🇧🇪Aalst, Belgium
CHU Saint-Pierre Bruxelles
🇧🇪Brussels, Belgium
Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove
🇧🇪Aalst, Belgium
AZ Sint-Lucas
🇧🇪Brugge, Belgium
Hôpital Erasme Bruxelles
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Universitaire ziekenhuizen Leuven
🇧🇪Leuven, Belgium
AZ Maria Middelares Gent
🇧🇪Gent, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen
🇧🇪Roeselare, Belgium
AZ Sint-Elisabeth Zottegem
🇧🇪Zottegem, Belgium
AZ Klina
🇧🇪Brasschaat, Belgium
AZ Sint-Jan Brugge-Oostende
🇧🇪Brugge, Belgium
AZ Sint Blasius Dendermonde
🇧🇪Dendermonde, Belgium
CHR de la Citadelle Liège
🇧🇪Liège, Belgium
GZA ziekenhuizen - Campus Sint-Augustinus
🇧🇪Antwerp, Belgium
CHIREC
🇧🇪Brussels, Belgium
AZ Jan Palfijn Gent
🇧🇪Gent, Belgium
AZ Sint-Lucas Gent
🇧🇪Gent, Belgium
CHU Ambroise Paré Mons
🇧🇪Mons, Belgium
AZ Jan Portaels
🇧🇪Vilvoorde, Belgium
Cliniques Universitaires de Mont-Godinne
🇧🇪Yvoir, Belgium