Using augmented reality to improve prostate cancer surgery outcomes
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 318 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Male |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06059859 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older with untreated, biopsy-proven low or intermediate risk prostate cancer.
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.
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 performed: Previous studies have shown promising results with augmented reality in surgical settings, but this specific approach is novel and requires further validation.
Eligibility criteria
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 this trial is running
Milan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.