NCT06318559

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: Male
• Age: 40 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cancer of Prostate

Interventions

Type	Name	Description
PROCEDURE	3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy	The operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted. Then a radical prostatectomy is performed.

Timeline

• Start date: 2022-06-29
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2024-03-19
• Last updated: 2024-03-19

Locations

2 sites across 1 country: Italy