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

RECRUITINGN/ASponsored by Sami-Ramzi Leyh-Bannurah
Actively Recruiting
PhaseN/A
SponsorSami-Ramzi Leyh-Bannurah
Started2024-01-30
Est. completion2030-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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)

Conditions2

CancerProstate Cancer (Localized), Urinary Incontinence (C61)

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