Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy IDEAL Stage 2a

ClinicalTrials.gov ID

NCT07678489

Lead Sponsor

Sami-Ramzi Leyh-BannurahOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Jul 1, 2026Actual

Start Date

Jan 30, 2024Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2030Estimated

Official Title

Total en Bloc Urethra Preservation at Robot-assisted Prostatectomy (ToP-RAP): A Prospective IDEAL Stage 2a Study

Brief Summary

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.

• Prostate Cancer (Localized), Urinary Incontinence (C61)

• ToP-RAP

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

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)

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Sami-Ramzi Leyh-BannurahOTHER

Collaborators

Clinic Bel Etage Dusseldorf, NRW, GermanyUNKNOWN

Mahmoud.Farzat@diakonie-sw.de+492713334525

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