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Clinical Trial Summary

This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.


Clinical Trial Description

Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles). Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06318559
Study type Interventional
Source Fondazione del Piemonte per l'Oncologia
Contact Enrico Checcucci, MD
Phone +390119933632
Email enrico.checcucci@ircc.it
Status Recruiting
Phase N/A
Start date June 29, 2022
Completion date December 31, 2027

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