Using augmented reality to improve prostate cancer surgery outcomes
Official title: 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
Run by European Institute of Oncology · NCT06059859 · Data updated 2026-11-12
This study is testing whether using augmented reality during prostate cancer surgery can lead to better outcomes and help preserve erectile function compared to standard surgery methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Men only |
| Enrollment | 318 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | January 1, 2026 |
| Study ends | January 1, 2026 |
| Registry record updated | August 12, 2025 |
| Trial ID | NCT06059859 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men aged 18 and older with untreated, biopsy-proven low or intermediate risk prostate cancer.
✕Probably not a fit
Patients with high-risk prostate cancer or those who have received prior therapy for prostate cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of augmented reality (AR) during robot-assisted radical prostatectomy (RARP) for patients with prostate cancer. It aims to compare the rates of positive surgical margins (PSMs) between AR RARP and the standard RARP approach. The study will also evaluate the preservation of neurovascular bundles and recovery of erectile function post-surgery. Patients will be randomized into two groups, with follow-up assessments at 3, 6, and 12 months to measure outcomes related to surgical success and erectile function recovery.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and better recovery of erectile function for prostate cancer patients.
How similar studies have gone: Previous studies have shown promising results with augmented reality in surgical settings, but this specific approach is novel and requires further validation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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
Where it's running
-
European Institute of Oncology
Milan, Italy Recruiting
Study contacts
- Principal investigator: Ottavio de Cobelli, MD; PhD — European Institute of Oncology
- Study coordinator: Stefano Luzzago, MD
- Email: stefano.luzzago@ieo.it
- Phone: +393335424928
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.