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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
View on ClinicalTrials.gov →
NCT07678489
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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Actively Recruiting
PhaseN/A
SponsorSami-Ramzi Leyh-Bannurah
Started2024-01-30
Est. completion2030-12-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07678489