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

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

Prospective single-arm IDEAL stage 2a feasibility study of urethra-preserving RARP in localized prostate cancer.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Localized), Urinary Incontinence (C61)
• Intervention / Treatment: Procedure: ToP-RAP

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Düsseldorf, Germany, 40217
    • Recruiting
    • Clinic Bel Etage
    • Contact: Jörn H Witt, Associate Professor; Phone Number: +492115426650; Email: info@urokompetenz.de
  • Siegen, Germany, 57074
    • Recruiting
    • Diakonie Klinikum Jung-Stilling
    • Contact: Mahmoud Farzat, MD; Phone Number: +492713334525; Email: Mahmoud.Farzat@diakonie-sw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ToP-RAP

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 from urethra-sparing *simple* prostatectomy, which is a benign (BPH) enucleation rather than whole-gland cancer surgery. The whole prostatic gland is removed while only the intraprostatic urethra is retained, with anterolateral neurovascular-bundle preservation.; Other Names: * Total en bloc Urethra Preservation at Robot-assisted Prostatectomy; Total Urethral Length Preservation; TULP; TUP-RAP; TUPRAP; TOPRAP; Urethra-sparing radical prostatectomy; Urethra-preserving robot-assisted radical prostatectomy; Complete (total) intraprostatic urethral preservation RARP; Total en bloc Urethral Preservation at Robot-assisted Prostatectomy; Full-length urethra-preserving RARP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility of ToP-RAP	Proportion of enrolled patients in whom ToP-RAP is completed per the pre-specified technical standards without intraoperative conversion to standard RARP.	Intraoperative (day of surgery)
Perioperative safety (Clavien-Dindo)	Rate and maximum grade of intra- and post-operative complications classified by the Clavien-Dindo system.	Up to 90 days after surgery
Time to urinary continence recovery	Days from surgery to urinary continence recovery defined as use of 0 or 1 safety pad per day. Inpatient continence is defined by Stamey criteria (medical expert assessment).	Up to 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PSA persistence and biochemical recurrence	PSA persistence (failure to reach <0.1 ng/mL within 12 weeks) and biochemical recurrence (PSA >=0.2 ng/mL) assessed on serial PSA measurements.	3, 6, 9, 12 and 24 months after surgery
Erectile function recovery	Post-ToP-RAP Erectile function recovery, measured via IIEF-5	Up to 24 months after surgery

Collaborators and Investigators

• Sponsor: Sami-Ramzi Leyh-Bannurah
• Collaborators: Clinic Bel Etage Dusseldorf, NRW, Germany
• Investigators: Study Director: Sami-Ramzi Leyh-Bannurah, Associate Professor, Martini Klinik am UKE GmbH, Hamburg-Eppendorf, Hamburg, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: June 20, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: HIFU; Prostatectomy; Feasibility study; IRE; single port; Prostatic neoplasms; Focal therapy; localized prostate cancer; NeuroSAFE; Urinary continence; Retzius sparing; IDEAL framework; DaVinci; nerve-sparing; multiport; HUGO RAS; Urethral sparing; Urethra-preserving; Bladder-neck preservation; Hood technique; Sleeve technique; Retzius-sparing radical prostatectomy; precision prostatectomy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Prostatic Neoplasms; Urinary Incontinence
• Other Study ID Numbers: 2025086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified patient-level data may be made available from the corresponding author upon reasonable request, subject to institutional approval and privacy/ethical restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No