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NCT06059859

Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

Recruiting now NA Last updated 12 August 2025
What this trial tests

NA trial testing Augmented reality robot-assited radical prostatectomy in Prostatic Neoplasm in 318 participants. Currently enrolling.

Timeline
1 January 2022
Primary endpoint
1 January 2026
1 January 2026

Quick facts

Lead sponsorEuropean Institute of Oncology
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment318
Start date1 January 2022
Primary completion1 January 2026
Estimated completion1 January 2026
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

European Institute of Oncology

Who can join

Adults 18 to 70, male only, with Prostatic Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Phase 3 Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins: A Clinical Trial Protocol.
    Musi G, Mistretta FA, de Cobelli O, Bellin A, et al · · 2024 · cited 4× · PMID 38333626 · DOI 10.1016/j.euros.2024.01.006

Verify or expand the search:

Other recruiting trials for Prostatic Neoplasm

Currently open trials in the same condition.

Other European Institute of Oncology trials

Trials by the same sponsor.

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Data sources for this page

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