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

Recruiting now · Not applicable

Conditions studied: Prostate Cancer (Localized), Urinary Incontinence (C61)

In brief

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

Key facts

Study ID

NCT07678489

Run by

Sami-Ramzi Leyh-Bannurah

People needed

60

Starts

2024-01-30

Expected to finish

2030-12-31

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Clinic Bel Etage — Düsseldorf, Germany (enrolling)
• Diakonie Klinikum Jung-Stilling — Siegen, Germany (enrolling)

Full record on ClinicalTrials.gov

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