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NCT Number: NCT07678489

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ToP-RAP

Procedure

**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

Primary outcomes

  1. Technical feasibility of ToP-RAP

    Time frame: Intraoperative (day of surgery)

    Proportion of enrolled patients in whom ToP-RAP is completed per the pre-specified technical standards without intraoperative conversion to standard RARP.

  2. Perioperative safety (Clavien-Dindo)

    Time frame: Up to 90 days after surgery

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

  3. Time to urinary continence recovery

    Time frame: Up to 12 months after surgery

    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).

Secondary outcomes

  1. PSA persistence and biochemical recurrence

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

    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.

  2. Erectile function recovery

    Time frame: Up to 24 months after surgery

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

Sponsors and collaborators

Lead sponsor

Sami-Ramzi Leyh-Bannurah

Other

Collaborators

  • Clinic Bel Etage Dusseldorf, NRW, Germany

Registry information

Official study title

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

Acronym: ToP-RAP

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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