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)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Prostate Cancer; Erectile Function; Urinary Function
• Intervention / Treatment: Procedure: Robot assisted laparoscopic prostatectomy

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.

• Study Type: Observational
• Enrollment (Actual): 9235

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Algemeen Stedelijk Ziekenhuis Aalst
  • Aalst, Belgium, 9300
    • Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove
  • Antwerp, Belgium, 2610
    • GZA Ziekenhuizen - Campus Sint-Augustinus
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge-Oostende
  • Brugge, Belgium, 8000
    • AZ Sint-Lucas
  • Brussels, Belgium, 1000
    • CHU Saint-Pierre Bruxelles
  • Brussels, Belgium, 1000
    • Institut Jules Bordet Bruxelles
  • Brussels, Belgium, 1070
    • Hôpital Erasme Bruxelles
  • Brussels, Belgium, 1160
    • CHIREC
  • Dendermonde, Belgium, 9200
    • Az Sint Blasius Dendermonde
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Gent, Belgium, 9000
    • AZ Jan Palfijn Gent
  • Gent, Belgium, 9000
    • AZ Maria Middelares Gent
  • Gent, Belgium, 9000
    • AZ Sint-Lucas Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven
  • Liège, Belgium, 4000
    • CHR de la Citadelle liege
  • Mons, Belgium, 7000
    • CHU Ambroise Paré Mons
  • Oostende, Belgium, 8400
    • AZ Damiaan
  • Roeselare, Belgium, 8800
    • AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen
  • Uccle, Belgium, 1180
    • Cliniques de l'Europe Bruxelles
  • Vilvoorde, Belgium, 1800
    • AZ Jan Portaels
  • Yvoir, Belgium, 5530
    • Cliniques Universitaires de Mont-Godinne
  • Zottegem, Belgium, 9620
    • AZ Sint-Elisabeth Zottegem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Procedure: Robot assisted laparoscopic prostatectomy; Other Names: +- postoperative treatments
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).	Procedure: Robot assisted laparoscopic prostatectomy; Other Names: +- postoperative treatments

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Belgian Cancer Registry
• Investigators: Principal Investigator: Steven Joniau, Professor, Department of Urology, KU Leuven, Leuven Belgium

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Overview activities cancer registry
• Legal base upon which usage and collection of data is explained

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2009
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: December 29, 2018
• First Submitted That Met QC Criteria: December 29, 2018
• First Posted (ACTUAL): January 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2019
• Last Update Submitted That Met QC Criteria: December 31, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: QoL; Quality of life; Erectile; Prostate cancer; follow-up; RARP; Low risk; High risk; functional outcomes; Urinary; Intermediate risk; Robot assisted radical prostatectomy; RALP; Post operation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: Be-RALP functioning and QoL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No