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

Sami-Ramzi Leyh-Bannurah60 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer (Localized), Urinary Incontinence (C61)

Interventions

ToP-RAPPROCEDURE

\*\*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.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Clinic Bel Etage

Düsseldorf, Germany

RECRUITING

Diakonie Klinikum Jung-Stilling

Siegen, Germany

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative (day of surgery)

Perioperative safety (Clavien-Dindo)

Rate and maximum grade of intra- and post-operative complications classified by the Clavien-Dindo system.

Time frame: 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).

Time frame: Up to 12 months after surgery

Secondary Outcomes

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.

Time frame: 3, 6, 9, 12 and 24 months after surgery

Erectile function recovery

Post-ToP-RAP Erectile function recovery, measured via IIEF-5

Time frame: Up to 24 months after surgery

Data from ClinicalTrials.gov

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