Status:
RECRUITING
Impact of Augmented Reality During Robot-assisted Radical Prostatectomy
Lead Sponsor:
European Institute of Oncology
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
18-70 years
Phase:
NA
Brief Summary
Accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (RARP). However, the nerve sparing approach is associat...
Detailed Description
This is a Phase III, monocentric, prospective trial in which patients will be randomized to AR RARP vs. standard approach (standard RARP). Patient population is defined as: patients≥18 years old, untr...
Eligibility Criteria
Inclusion
- Untreated, biopsy-proven adenocarcinoma of the prostate Age ≥18 years
- European Association of Urology (EAU) low or intermediate risk prostate cancer:
- PSA≤20 ng/ml
- cT≤2b
- International Society for Urological Pathology \[ISUP\] grade group≤III Written informed consent provided for participation in the trial International Index of Erectile Function-5 (IIEF-5)≥20 No contraindications for multiparametric magnetic resonance imaging (mpMRI)
Exclusion
- Any prior therapy for prostate cancer
- European Association of Urology (EAU) high risk prostate cancer:
- PSA\>20 ng/ml or
- cT\>2b or
- ISUP grade group\>III International Index of Erectile Function-5 (IIEF-5)\<20 Prostate cancer with sarcomatoid or spindle cell or neuroendocrine small cell components Morbidity that would limit compliance with study protocols Controindications to perform mpMRI
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT06059859
Start Date
January 1 2022
End Date
January 1 2026
Last Update
August 12 2025
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy, 20141