Artificial Intelligence 3D Augmented Reality-guided Robotic Prostatectomy Versus Cognitive MRI Intervention: Results of the Prospective Randomized RIDERS Trial.

[BACKGROUND AND OBJECTIVE] Three-dimensional (3D) augmented reality (AR) and artificial intelligence (AI) technologies have recently been introduced to enhance guidance during robot-assisted radical prostatectomy (RARP). By overlaying virtual and real-time images, this approach helps accurately localize hidden lesions during surgery, enabling the execution of tailored procedures. This study aimed to evaluate whether 3D-AI-AR guidance reduces positive surgical margins (PSMs) compared with standard tw0-dimensional (2D) magnetic resonance imaging (MRI)-based interventions.

[METHODS] In this prospective, multicenter randomized controlled trial (NCT06318559), 133 patients with extracapsular extension or bulging at preoperative MRI were enrolled and randomized (2:1) to either 2D MRI-guided (n = 84) or 3D-AI-AR-guided RARP (n = 49). All the patients underwent nerve-sparing RARP. Intraoperative selective biopsies were then performed at the level of the preserved neurovascular bundle (NVB): cognitive in the MRI group and AR guided in the 3D group. The primary outcomes included PSM rate. Prostate-specific antigen (PSA) levels, continence, and potency recovery were assessed during the 12 mo of follow-up. The use of postoperative radiotherapy was recorded. Biochemical recurrence (BCR) was defined as PSA >0.4 ng/ml. All the analyses were conducted with SAS Statistics Software v.9.4.

[KEY FINDINGS AND LIMITATIONS] Baseline and intraoperative characteristics were similar between the groups. While PSMs on prostate surface were comparable (p = 0.8), 3D-guided excisional biopsies had a significantly higher positivity rate (52% vs 13%; p = 0.001), allowing an improved margin control. The 3D group had a lower overall PSM rate (22% vs 39%; p = 0.047), required less postoperative RT (18% vs 35%; p = 0.046), and showed higher continence at 12 mo (91% vs 71%; p = 0.03). Potency and BCR rates were similar.

[CONCLUSIONS AND CLINICAL IMPLICATIONS] The execution of a 3D-AI-AR-guided biopsy at the level of preserved NVBs during nerve-sparing RARP allows correct identification of the tumor with subsequent improvement of margin control. Longer follow-up is required to assess the functional and long-term oncological outcomes of this approach.