Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Function | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
| Urinary Function | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robot assisted laparoscopic prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- High risk prostate cancer
- description
- 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).
- interventionNames
- Procedure: Robot assisted laparoscopic prostatectomy
- label
- Low - intermediate risk prostate cancer
- description
- 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).
- interventionNames
- Procedure: Robot assisted laparoscopic prostatectomy
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDAlbisinni 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. PMID 28743170
- BACKGROUNDTosco 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. PMID 31100256