Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Prostate Cancer, Quality of Life, Erectile Function, Urinary Function

Intervention / Treatment
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* Procedure: Robot assisted laparoscopic prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with prostate cancer Eligible to undergo RALP RALP in one of the 25 participating centres Exclusion Criteria: iPSA > 100 Confirmed metastasis invalid survival data pT0 Missing nerve sparing details Missing risk group
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High risk prostate cancer<br>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). | Procedure: Robot assisted laparoscopic prostatectomy<br> <br> * Other names: +- postoperative treatments;|
| Low - intermediate risk prostate cancer<br>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). | Procedure: Robot assisted laparoscopic prostatectomy<br> <br> * Other names: +- postoperative treatments;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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