Prostate CancerNCT03790995
Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP
An observational study of Prostate Cancer and Quality of Life, run by KU Leuven at 25 sites in Belgium.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Quality of Life, Erectile Function
- What is being tested?
- Robot assisted laparoscopic prostatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 9,235 participants
- Where
- 25 sitesBelgium
- Study dates
- Oct 2009to Feb 2018
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Diagnosed with prostate cancer
- Eligible to undergo RALP
- RALP in one of the 25 participating centres
Who cannot join
- iPSA > 100
- Confirmed metastasis
- invalid survival data
- pT0
- Missing nerve sparing details
- Missing risk group
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Belgium25 sites
Algemeen Stedelijk Ziekenhuis Aalst
Aalst, 9300
Onze-Lieve-Vrouwziekenhuis Aalst-Asse-Ninove
Aalst, 9300
GZA ziekenhuizen - Campus Sint-Augustinus
Antwerp, 2610
AZ Klina
Brasschaat, 2930
AZ Sint-Jan Brugge-Oostende
Bruges, 8000
AZ Sint-Lucas
Bruges, 8000
CHU Saint-Pierre Bruxelles
Brussels, 1000
Institut Jules Bordet Bruxelles
Brussels, 1000
Hôpital Erasme Bruxelles
Brussels, 1070
CHIREC
Brussels, 1160
AZ Sint Blasius Dendermonde
Dendermonde, 9200
AZ Jan Palfijn Gent
Ghent, 9000
AZ Maria Middelares Gent
Ghent, 9000
AZ Sint-Lucas Gent
Ghent, 9000
Universitair Ziekenhuis Gent
Ghent, 9000
AZ Groeninge
Kortrijk, 8500
Universitaire ziekenhuizen Leuven
Leuven, 3000
CHR de la Citadelle Liège
Liège, 4000
CHU Ambroise Paré Mons
Mons, 7000
AZ Damiaan
Ostend, 8400
AZ Delta-Heilig Hart Ziekenhuis Roeselare-Menen
Roeselare, 8800
Cliniques de l'Europe Bruxelles
Uccle, 1180
AZ Jan Portaels
Vilvoorde, 1800
Cliniques Universitaires de Mont-Godinne
Yvoir, 5530
AZ Sint-Elisabeth Zottegem
Zottegem, 9620
About this study
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)
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.
Read the 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.
- Conditions
- Prostate Cancer, Quality of Life, Erectile Function, Urinary Function
- Being tested
- Robot assisted laparoscopic prostatectomy
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted laparoscopic prostatectomyProcedure or surgery
Also called +- postoperative treatments
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: 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). Receives: Procedure: Robot assisted laparoscopic prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global quality of life
EORTC C30 global quality of life, questionnaire
Measured: Longitudinal modelling over 24 months
Emotional quality of life
EORTC C30 emotional quality of life, questionnaire
Measured: Longitudinal modelling over 24 months
physical quality of life
EORTC C30 physical quality of life, questionnaire
Measured: Longitudinal modelling over 24 months
Cognitive quality of life
EORTC C30 cognitive quality of life, questionnaire
Measured: Longitudinal modelling over 24 months
Erectile function - IIEF 5
International Index of Erectile Function (IIEF-5), questionnaire
Measured: Longitudinal modelling over 24 months
Erectile function - sexual activity
EORTC PR25 sexual activity, questionnaire
Measured: Longitudinal modelling over 24 months
Erectile function - sexual functioning
EORTC PR25 sexual functioning, questionnaire
Measured: Longitudinal modelling over 24 months
Urinary function - Incontinence aid
EORTC PR25 incontinence aid, questionnaire
Measured: Longitudinal modelling over 24 months
Urinary function - urinary symptoms
EORTC PR25 urinary symptoms, questionnaire
Measured: Longitudinal modelling over 24 months
Urinary function - ICIQ
International Consultation on Incontinence Questionnaire
Measured: Longitudinal modelling over 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study startOct 2009
- Primary completionFeb 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9,235 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Cancer Registry
- Responsible party
- Principal investigator, Wout Devlies, KU Leuven
- Investigators
- Steven Joniau, Professor, Principal investigator, Department of Urology, KU Leuven, Leuven Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790995
- Sponsor's protocol ID
- Be-RALP functioning and QoL
- Status last verified
- Dec 2018
- First submitted
- 29 Dec 2018
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
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.
PubMed 28743170Tosco 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.
PubMed 31100256
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03790995
- Acronym / sponsor ID
- Be-RALP functioning and QoL
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,235 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Belgian Cancer Registry
- Study start
- Oct 2009 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk prostate cancer | – | Procedure: Robot assisted laparoscopic prostatectomyPatients 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). |
| Low - intermediate risk prostate cancer | – | Procedure: Robot assisted laparoscopic prostatectomyInitial 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). |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Diagnosed with prostate cancer
- Eligible to undergo RALP
- RALP in one of the 25 participating centres
Key exclusion criteria (6 listed)
- iPSA > 100
- Confirmed metastasis
- invalid survival data
- pT0
- Missing nerve sparing details
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot assisted laparoscopic prostatectomyAlso: +- postoperative treatments | Procedure or surgery | High risk prostate cancer, Low - intermediate risk prostate cancer |
Primary outcome
Global quality of life
Time frame: Longitudinal modelling over 24 months
EORTC C30 global quality of life, questionnaire
Emotional quality of life
Time frame: Longitudinal modelling over 24 months
EORTC C30 emotional quality of life, questionnaire
physical quality of life
Time frame: Longitudinal modelling over 24 months
EORTC C30 physical quality of life, questionnaire
Cognitive quality of life
Time frame: Longitudinal modelling over 24 months
EORTC C30 cognitive quality of life, questionnaire
Erectile function - IIEF 5
Time frame: Longitudinal modelling over 24 months
International Index of Erectile Function (IIEF-5), questionnaire
Erectile function - sexual activity
Time frame: Longitudinal modelling over 24 months
EORTC PR25 sexual activity, questionnaire
Erectile function - sexual functioning
Time frame: Longitudinal modelling over 24 months
EORTC PR25 sexual functioning, questionnaire
Urinary function - Incontinence aid
Time frame: Longitudinal modelling over 24 months
EORTC PR25 incontinence aid, questionnaire
Urinary function - urinary symptoms
Time frame: Longitudinal modelling over 24 months
EORTC PR25 urinary symptoms, questionnaire
Urinary function - ICIQ
Time frame: Longitudinal modelling over 24 months
International Consultation on Incontinence Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Background: PubMed 28743170Albisinni 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.
- Background: PubMed 31100256Tosco 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.
- Legal base upon which usage and collection of data is explainedLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Joniau, Professor principal investigator
Department of Urology, KU Leuven, Leuven Belgium
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Quality of Life, run by KU Leuven at 25 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global quality of life (time frame: Longitudinal modelling over 24 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03790995, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.