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| Name | Class |
|---|---|
| Clinic Bel Etage Dusseldorf, NRW, Germany | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ToP-RAP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion Criteria:
- Failure to meet any inclusion criterion, or patient declining ToP-RAP (offered standard RARP per EAU guidelines)
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| Name | Affiliation | Role |
|---|---|---|
| Sami-Ramzi Leyh-Bannurah, Associate Professor | Martini Klinik am UKE GmbH, Hamburg-Eppendorf, Hamburg, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic Bel Etage | Recruiting | Düsseldorf | 40217 | Germany |
De-identified patient-level data may be made available from the corresponding author upon reasonable request, subject to institutional approval and privacy/ethical restrictions.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Post-ToP-RAP Erectile function recovery, measured via IIEF-5 |
| Up to 24 months after surgery |
| Diakonie Klinikum Jung-Stilling | Recruiting | Siegen | 57074 | Germany |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |