Clinical trial NCT03790995: Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Quality of Life
Erectile Function
Urinary Function
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
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Belgian Cancer Registry
First posted: 2019-01-02
Enrollment: 9235
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global quality of life
timeFrame: Longitudinal modelling over 24 months
measure: Emotional quality of life
timeFrame: Longitudinal modelling over 24 months
measure: physical quality of life
timeFrame: Longitudinal modelling over 24 months
measure: Cognitive quality of life
timeFrame: Longitudinal modelling over 24 months
measure: Erectile function - IIEF 5
timeFrame: Longitudinal modelling over 24 months
measure: Erectile function - sexual activity
timeFrame: Longitudinal modelling over 24 months
measure: Erectile function - sexual functioning
timeFrame: Longitudinal modelling over 24 months
measure: Urinary function - Incontinence aid
timeFrame: Longitudinal modelling over 24 months
measure: Urinary function - urinary symptoms
timeFrame: Longitudinal modelling over 24 months
measure: Urinary function - ICIQ
timeFrame: Longitudinal modelling over 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis Aalst
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove
city: Antwerp
country: Belgium
facility: GZA ziekenhuizen - Campus Sint-Augustinus
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende
city: Brugge
country: Belgium
facility: AZ Sint-Lucas
city: Brussels
country: Belgium
facility: CHU Saint-Pierre Bruxelles
city: Brussels
country: Belgium
facility: Institut Jules Bordet Bruxelles
city: Brussels
country: Belgium
facility: Hôpital Erasme Bruxelles
city: Brussels
country: Belgium
facility: CHIREC
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius Dendermonde
city: Gent
country: Belgium
facility: AZ Jan Palfijn Gent
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent
city: Gent
country: Belgium
facility: AZ Sint-Lucas Gent
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: Universitaire ziekenhuizen Leuven
city: Liège
country: Belgium
facility: CHR de la Citadelle Liège
city: Mons
country: Belgium
facility: CHU Ambroise Paré Mons
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Roeselare
country: Belgium
facility: AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen
city: Uccle
country: Belgium
facility: Cliniques de l'Europe Bruxelles
city: Vilvoorde
country: Belgium
facility: AZ Jan Portaels
city: Yvoir
country: Belgium
facility: Cliniques Universitaires de Mont-Godinne
city: Zottegem
country: Belgium
facility: AZ Sint-Elisabeth Zottegem
Study officials:
affiliation: Department of Urology, KU Leuven, Leuven Belgium
name: Steven Joniau, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.