NCT06059859Recruiting
Impact of Augmented Reality During Robot-assisted Radical Prostatectomy
A Phase III Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins
Source: ClinicalTrials.gov · Last updated 12 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 318 (estimated)
- First submitted
- 13 Sept 2023
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- European Institute of Oncology
- Diseases
- Prostate cancer
- NCT number
- NCT06059859
What you commit to
- Study type: Interventional
- Planned participants: 318
- From 1 Jan 2022 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior therapy for prostate cancer
Other illness
- European Association of Urology (EAU) high risk prostate cancer:
- 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
Other
- PSA\>20 ng/ml or
- cT\>2b or
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| European Institute of Oncology Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.