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

Recruiting · NCT07678489 · Interventional (participants receive a specific treatment) · Lead sponsor: Sami-Ramzi Leyh-Bannurah

Interventions studied

ToP-RAP

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

Age range

18 Years and older

Sex

Male

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

\- Failure to meet any inclusion criterion, or patient declining ToP-RAP (offered standard RARP per EAU guidelines)

2 locations listed.