Comparison of Oncological Outcomes Between Open Radical Prostatectomy and Robotic-Assisted Radical Prostatectomy for Localized Prostate Carcinoma: A Systematic Review of Randomized Controlled Trials and Primary Studies

Abstract

Introduction: Prostate carcinoma (PCa) is the second most frequently diagnosed malignancy in males globally, and radical prostatectomy (RP) constitutes the cornerstone of curative-intent surgical management for localized disease. Open radical prostatectomy (ORP) has been the historical gold standard; however, robotic-assisted radical prostatectomy (RARP) has experienced rapid, widespread adoption over the past two decades. Despite this diffusion, comparative oncological efficacy between the two platforms has remained under debate. This systematic review comprehensively compares oncological outcomes—including positive surgical margin (PSM) rates, biochemical recurrence (BCR), prostate cancer-specific survival (PCSS), overall survival (OS), and perioperative oncological parameters—between ORP and RARP for clinically localized PCa. Methods: The study strictly adhered to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020 guidelines. Eligible studies included randomized controlled trials (RCTs), cohort studies (prospective and retrospective), case-control studies, and cross-sectional observational studies directly comparing ORP with RARP in patients with clinically localized PCa. Risk of bias was evaluated using the Cochrane Risk of Bias 2 (RoB 2) tool for RCTs and the Newcastle-Ottawa Scale (NOS) for observational studies. Results: Twenty primary studies (3 RCTs, 17 observational cohort studies) encompassing >700,000 patients were included. RARP demonstrated lower PSM rates in the majority of large observational studies (OR 0.56–0.88, p<0.001 in several series), while results from RCTs were non-inferior but not significantly different. BCR rates were similar in RCTs (non-significant at 24–36 months), but long-term cohort data (12-year follow-up LAPPRO trial) demonstrated significantly lower PCSS-mortality in the RARP group (HR 0.36; 95% CI 0.23–0.55). RARP offered significant perioperative advantages: reduced estimated blood loss (192–250 vs. 710–852 mL), decreased transfusion rates, shorter hospitalization, fewer major postoperative complications, and lower 30-day mortality. Functional recovery of urinary continence and erectile function was superior in early time points for RARP, with equivalence observed at 24 months in RCTs. Discussion: The data synthesis from RCTs and large observational cohorts indicates that RARP is at least oncologically non-inferior to ORP across short- to medium-term follow-up periods, with accumulating long-term evidence suggesting potential superiority in PCSS. Perioperative and functional advantages of RARP are well-established. The surgeon learning curve, institutional volume, and patient risk stratification are critical confounders that must be considered when interpreting comparative data. The heterogeneity of follow-up durations and BCR definitions across studies constitutes a significant limitation of the current evidence base. Conclusion: RARP demonstrates oncological outcomes equivalent to ORP in short- and medium-term follow-up, with emerging long-term evidence supporting potential superiority in PCSS. Given its robust perioperative and functional advantages, RARP may be considered the preferred surgical approach for localized PCa in high-volume robotic centers. Large-scale, long-term RCTs remain necessary to definitively establish oncological equivalence or superiority.