Comparing Artificial Intelligence 3D Augmented Reality with Standard Robot-Assisted Radical Prostatectomy in Men with Prostate Cancer

What this Trial Is About

Researchers are investigating the impact of using Artificial Intelligence 3D Augmented Reality AI 3D AR during robot-assisted radical prostatectomy compared to surgery without 3D guidance in men with prostate cancer. The study aims to see if this technology can improve both cancer control and functional outcomes, such as urinary continence and sexual potency, especially for tumors invading the prostate capsule or seminal vesicles. This prospective randomized multicenter trial evaluates whether AI 3D AR reduces the risk of positive surgical margins and the need for additional treatments. Participants will undergo robot-assisted laparoscopic radical prostatectomy using the Da Vinci HD robotic system. In the 3D group, surgeons use AI software to project virtual 3D images of the prostate and tumor during surgery, guiding nerve-sparing techniques and targeted biopsies to check for cancer spread. The no-3D group will have surgery guided by conventional methods, including cognitive biopsies based on MRI. Both groups receive a reconstructive phase following total anatomical reconstruction techniques. During the study, participants will be monitored for surgical and cancer outcomes at 12 months after surgery, with longer-term assessments of urinary function, sexual function, and oncological results over five years. Follow-up visits will collect clinical data and evaluate the benefits and risks of using AI 3D AR. The study includes men aged 40 to 99 years with specific prostate cancer characteristics confirmed by MRI and biopsy.

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