Functional Outcomes and QoL in Patients With High Versus Low and Intermediate Risk Prostate Cancer Treated by RARP
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| ClinicalTrials.gov Identifier: NCT03790995 |
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Recruitment Status :
Completed
First Posted : January 2, 2019
Last Update Posted : January 3, 2019
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Prostate Cancer Quality of Life Erectile Function Urinary Function | Procedure: Robot assisted laparoscopic prostatectomy |
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 [Patient Registry] |
| Actual Enrollment : | 9235 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 24 Months |
| 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) |
| Actual Study Start Date : | October 2009 |
| Actual Primary Completion Date : | February 2016 |
| Actual Study Completion Date : | February 2018 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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). |
Procedure: Robot assisted laparoscopic prostatectomy
Other Name: +- postoperative treatments |
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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 Name: +- postoperative treatments |
- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03790995
Show 25 study locations
| Principal Investigator: | Steven Joniau, Professor | Department of Urology, KU Leuven, Leuven Belgium |
Publications:
| Responsible Party: | Wout Devlies, Principal Investigator, KU Leuven |
| ClinicalTrials.gov Identifier: | NCT03790995 |
| Other Study ID Numbers: |
Be-RALP functioning and QoL |
| First Posted: | January 2, 2019 Key Record Dates |
| Last Update Posted: | January 3, 2019 |
| Last Verified: | December 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |