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

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790995
• Other study ID #: Be-RALP functioning and QoL
• Status: Completed
• Start date: October 2009
• Est. completion date: February 2018

Study information

• Verified date: December 2018
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 9235
• Est. completion date: February 2018
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Erectile Function
• Prostate Cancer
• Prostatic Neoplasms
• Quality of Life
• Urinary Function

Intervention

Procedure:
• Robot assisted laparoscopic prostatectomy

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis Aalst	Aalst
Belgium	Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove	Aalst
Belgium	GZA ziekenhuizen - Campus Sint-Augustinus	Antwerp
Belgium	AZ Klina	Brasschaat
Belgium	AZ Sint-Jan Brugge-Oostende	Brugge
Belgium	AZ Sint-Lucas	Brugge
Belgium	CHIREC	Brussels
Belgium	CHU Saint-Pierre Bruxelles	Brussels
Belgium	Hôpital Erasme Bruxelles	Brussels
Belgium	Institut Jules Bordet Bruxelles	Brussels
Belgium	AZ Sint Blasius Dendermonde	Dendermonde
Belgium	AZ Jan Palfijn Gent	Gent
Belgium	AZ Maria Middelares Gent	Gent
Belgium	AZ Sint-Lucas Gent	Gent
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	AZ Groeninge	Kortrijk
Belgium	Universitaire ziekenhuizen Leuven	Leuven
Belgium	CHR de la Citadelle Liège	Liège
Belgium	CHU Ambroise Paré Mons	Mons
Belgium	AZ Damiaan	Oostende
Belgium	AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen	Roeselare
Belgium	Cliniques de l'Europe Bruxelles	Uccle
Belgium	AZ Jan Portaels	Vilvoorde
Belgium	Cliniques Universitaires de Mont-Godinne	Yvoir
Belgium	AZ Sint-Elisabeth Zottegem	Zottegem

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Belgian Cancer Registry

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Albisinni S, Joniau S, Quackels T, De Coster G, Dekuyper P, Van Cleynenbreugel B, Van Damme N, Van Eycken E, Ameye F, Roumeguère 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. — View Citation

Lorenzo,Tosco, Greet De Coster, Thierry Roumeguère et all, the 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. September 2018, Pages 338-345

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global quality of life	EORTC C30 global quality of life, questionnaire	Longitudinal modelling over 24 months
Primary	Emotional quality of life	EORTC C30 emotional quality of life, questionnaire	Longitudinal modelling over 24 months
Primary	physical quality of life	EORTC C30 physical quality of life, questionnaire	Longitudinal modelling over 24 months
Primary	Cognitive quality of life	EORTC C30 cognitive quality of life, questionnaire	Longitudinal modelling over 24 months
Primary	Erectile function - IIEF 5	International Index of Erectile Function (IIEF-5), questionnaire	Longitudinal modelling over 24 months
Primary	Erectile function - sexual activity	EORTC PR25 sexual activity, questionnaire	Longitudinal modelling over 24 months
Primary	Erectile function - sexual functioning	EORTC PR25 sexual functioning, questionnaire	Longitudinal modelling over 24 months
Primary	Urinary function - Incontinence aid	EORTC PR25 incontinence aid, questionnaire	Longitudinal modelling over 24 months
Primary	Urinary function - urinary symptoms	EORTC PR25 urinary symptoms, questionnaire	Longitudinal modelling over 24 months
Primary	Urinary function - ICIQ	International Consultation on Incontinence Questionnaire	Longitudinal modelling over 24 months

External Links

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