Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP
NCT ID: NCT03790995
Last Updated: 2019-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
9235 participants
OBSERVATIONAL
2009-10-31
2018-02-28
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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).
Robot assisted laparoscopic prostatectomy
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).
Robot assisted laparoscopic prostatectomy
Interventions
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Robot assisted laparoscopic prostatectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eligible to undergo RALP
* RALP in one of the 25 participating centres
Exclusion Criteria
* Confirmed metastasis
* invalid survival data
* pT0
* Missing nerve sparing details
* Missing risk group
MALE
No
Sponsors
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Belgian Cancer Registry
OTHER
KU Leuven
OTHER
Responsible Party
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Wout Devlies
Principal Investigator
Principal Investigators
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Steven Joniau, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, KU Leuven, Leuven Belgium
Locations
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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
Bruges, , Belgium
AZ Sint-Lucas
Bruges, , Belgium
CHU Saint-Pierre Bruxelles
Brussels, , Belgium
Institut Jules Bordet Bruxelles
Brussels, , Belgium
Hôpital Erasme Bruxelles
Brussels, , Belgium
CHIREC
Brussels, , Belgium
AZ Sint Blasius Dendermonde
Dendermonde, , Belgium
AZ Jan Palfijn Gent
Ghent, , Belgium
AZ Maria Middelares Gent
Ghent, , Belgium
AZ Sint-Lucas Gent
Ghent, , Belgium
Universitair Ziekenhuis Gent
Ghent, , 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
Ostend, , 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, , Belgium
Countries
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References
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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.
Other Identifiers
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Be-RALP functioning and QoL
Identifier Type: -
Identifier Source: org_study_id
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