Comparative Safety and Efficacy of the Novel Surgical Robot Edge MP1000 vs da Vinci Xi in Robot-Assisted Radical Prostatectomy

Objective: To compare the safety and efficacy of the Edge MP1000 surgical robot with the da Vinci Xi system in robot-assisted radical prostatectomy (RARP) for clinically localized (≤T2bN0M0) prostate cancer, predominantly low to intermediate risk. Patients and Methods: A multicenter, randomized, single-blind, noninferiority trial was executed across three specialized medical centers in China from May 2023 to January 2024. A total of 80 patients with clinically localized prostate cancer (≤T2bN0M0), predominantly low to intermediate risk, were enrolled and randomized in a 1:1 ratio to undergo RARP using either the Edge MP1000 system ( n = 40) or the da Vinci Xi system ( n = 40). The prespecified primary endpoint (surgical success) was available for all 80 randomized patients and was analyzed on an intention-to-treat basis; 73 patients (36 vs 37) completed the 12-week follow-up and constituted the per-protocol population. The primary endpoint was the surgical success rate, which was defined as the successful completion of all planned procedural steps without any necessity for conversion to open or traditional laparoscopic surgery. Secondary endpoints encompassed a comprehensive evaluation of perioperative parameters, including operative time, docking time, and estimated blood loss, as well as short-term functional outcomes such as urinary continence recovery and renal function. Results: The surgical success rate was 100% in both groups, with no conversions to open or laparoscopic surgery. The absolute difference in success rates was 0% (95% confidence interval [CI] −8.8% to 8.8%) and the lower limit of this interval exceeded the prespecified noninferiority margin of −20%, demonstrating noninferiority ( p < 0.001). Consistent findings were obtained in the per-protocol population (36 vs 37; difference 0%, 95% CI −9.6% to 9.4%). No statistically significant differences were observed between the groups in operative time (194.1 ± 67.89 vs 174.6 ± 38.73 minutes, p = 0.135), docking time, estimated blood loss, positive surgical margin rate (5.6% vs 5.4%), immediate urinary continence (80.6% vs 83.8%), estimated Glomerular Filtration Rate at all timepoints, drainage, catheter time, or length of stay (all p > 0.05). Adverse events were limited to Grade I only (2.8% vs 5.4%, p = 1.000), with no device-related complications reported. Conclusions: Within the constraints of a modest sample size and a 12-week follow-up, the Edge MP1000 was noninferior to the da Vinci Xi for the prespecified primary endpoint of surgical success and showed no difference in early safety signals. These results provide preliminary evidence of short-term feasibility and safety and should not be extrapolated to longer-term oncological or functional equivalence.