Clinical trial · Interventional
Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy IDEAL Stage 2a
Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 2a Study
NCT07678489CI-TRIAL-00116422ToP-RAPrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective single-arm IDEAL stage 2a feasibility study of urethra-preserving RARP in localized prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Localized), Urinary Incontinence (C61) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ToP-RAP | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ToP-RAP
- interventionNames
- Procedure: ToP-RAP
Primary outcomes (3)
- measure
- Technical feasibility of ToP-RAP
- timeFrame
- Intraoperative (day of surgery)
- description
- Proportion of enrolled patients in whom ToP-RAP is completed per the pre-specified technical standards without intraoperative conversion to standard RARP.
- measure
- Perioperative safety (Clavien-Dindo)
- timeFrame
- Up to 90 days after surgery
- description
- Rate and maximum grade of intra- and post-operative complications classified by the Clavien-Dindo system.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Life expectancy \>=10 years (biological age) * No prior prostate therapy (laser enucleation, TURP, focal therapy) * No pelvic/prostate radiotherapy; * No prior abdominal/rectal surgery; * No prior (neoadjuvant) androgen-deprivation therapy * No prior stroke/cerebral ischemia with neurological sequelae; * No neurological disease (e.g., Parkinson's) * Transrectal or transperineal bilateral biopsy \>=12 cores (MRI-ultrasound fusion, targeted + systematic) * PSA \<=15 ng/mL; prostate volume \<=80 mL * Biopsy ISUP grade 1-3 (= Gleason 3+3 / 3+4 / 4+3) * No Gleason pattern 5; no intraductal, cribriform or neuroendocrine carcinoma * mp/bpMRI (mandatory if biopsy Gleason \>=3+4) * No suspected metastases at staging Exclusion Criteria: \- Failure to meet any inclusion criterion, or patient declining ToP-RAP (offered standard RARP per EAU guidelines)
References
Publications (0)
Data not yet available
No reference posted for this study.