Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy IDEAL Stage 2a
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ToP-RAP.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Localized), Urinary Incontinence (C61). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 2a Study
Overview
Prospective single-arm IDEAL stage 2a feasibility study of urethra-preserving RARP in localized prostate cancer.
Detailed description
Our study introduces a urethra-preserving prostatectomy concept that maintains the entire intraprostatic urethra, thereby avoiding both urethral transection and vesicourethral anastomosis. We embed the technique in a transparent IDEAL-based framework with predefined intra-operative decision rules, including prespecified conversion to standard robot-assisted radical prostatectomy. This positions the technique as a distinct step beyond existing bladder neck- or urethra-sparing modifications, and provides the first prospective multicentre data supporting its feasibility in selected patients.
Interventions
- Procedure ToP-RAP
\*\*ToP-RAP\*\* is a urethra-preserving modification of robot-assisted radical prostatectomy (RARP) for localized prostate cancer. Its distinguishing feature is preservation of the \*\*entire intraprostatic urethra with complete omission of urethral transection and the vesicourethral anastomosis\*\*. This separates it mechanistically from standard RARP, Retzius-sparing RARP, and the hood and sleeve techniques - all of which transect the urethra and reconstruct a vesicourethral anastomosis - and
Primary outcome measures
- Technical feasibility of ToP-RAP [Time frame: Intraoperative (day of surgery)]
- Perioperative safety (Clavien-Dindo) [Time frame: Up to 90 days after surgery]
- Time to urinary continence recovery [Time frame: Up to 12 months after surgery]
Secondary outcome measures (2)
- PSA persistence and biochemical recurrence [Time frame: 3, 6, 9, 12 and 24 months after surgery]
- Erectile function recovery [Time frame: Up to 24 months after surgery]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- Clinic Bel Etage — Düsseldorf
- Diakonie Klinikum Jung-Stilling — Siegen
Identifiers
NCT: NCT07678489 · 2025086