Actively Recruiting
Impact of Augmented Reality During Robot-assisted Radical Prostatectomy
Led by European Institute of Oncology · Updated on 2025-08-12
318
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 associated with higher rates of positive surgical margins (PSM) at final pathology. Augmented reality (AR) RARP was previously associated with a 10-15% reduction in the rates of PSMs in two retrospective series. However, prospective studies are needed to demonstrate clinical utility and to validate these technologies. The hypotheses of this study are that: 1) AR RARP reduces the rates of PSMs, if compared to standard approach; 2) AR RARP can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of PSMs will translate in greater oncological control of the disease.
CONDITIONS
Official Title
Impact of Augmented Reality During Robot-assisted Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Untreated, biopsy-proven adenocarcinoma of the prostate
- Age 18 to 70 years
- European Association of Urology (EAU) low or intermediate risk prostate cancer: PSA 60;20 ng/ml, clinical stage cT 60;2b, ISUP grade group 60;III
- Pre-operative International Index of Erectile Function-5 (IIEF-5) score 60;20
- No contraindications for multiparametric magnetic resonance imaging (mpMRI)
- Written informed consent provided for participation in the trial
You will not qualify if you...
- Any prior therapy for prostate cancer
- European Association of Urology (EAU) high risk prostate cancer: PSA >20 ng/ml, clinical stage >2b, or ISUP grade group >III
- International Index of Erectile Function-5 (IIEF-5) score <20
- Prostate cancer with sarcomatoid, spindle cell, or neuroendocrine small cell components
- Morbidity that would limit compliance with study protocols
- Contraindications to perform multiparametric magnetic resonance imaging (mpMRI)
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
Research Team
S
Stefano Luzzago, MD
CONTACT
F
Francesco A Mistretta, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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