Prostate Cancer (Localized), Urinary Incontinence (C61)
Conditions
Keywords
Prostatectomy, Urethral sparing, Urethra-preserving, NeuroSAFE, nerve-sparing, Focal therapy, IRE, HIFU, Urinary continence, Bladder-neck preservation, Hood technique, Sleeve technique, IDEAL framework, Retzius sparing, DaVinci, multiport, single port, HUGO RAS, Feasibility study, Prostatic neoplasms, localized prostate cancer, Retzius-sparing radical prostatectomy, precision prostatectomy
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.
Interventions
PROCEDUREToP-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.
Sponsors
Sami-Ramzi Leyh-Bannurah
Clinic Bel Etage Dusseldorf, NRW, Germany
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical feasibility of ToP-RAP | 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. |
| Perioperative safety (Clavien-Dindo) | Up to 90 days after surgery | Rate and maximum grade of intra- and post-operative complications classified by the Clavien-Dindo system. |
| Time to urinary continence recovery | 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
| Measure | Time frame | Description |
|---|---|---|
| PSA persistence and biochemical recurrence | 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. |
| Erectile function recovery | Up to 24 months after surgery | Post-ToP-RAP Erectile function recovery, measured via IIEF-5 |
Countries
Germany
Contacts
STUDY_DIRECTORSami-Ramzi Leyh-Bannurah, Associate Professor
Martini Klinik am UKE GmbH, Hamburg-Eppendorf, Hamburg, Germany
Outcome results
None listed