Spots Global Cancer Trial Database for Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

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Trial Identification

Brief Title: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

Official Title: RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial

Study ID: NCT06318559

Conditions

Cancer of Prostate

Interventions

3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Study Description

Brief 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.

Detailed 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).