A novel strategy for localized and locally-advanced prostate cancer management during COVID-19 pandemic scenario. An integrated analysis from triage protocols evaluation to the development of a new prognostic model for a risk-adapted approach

Summary The COVID-19 pandemic has critically emphasized the need for of a mindful employment of financial and human resources. Several opinion leaders worldwide have proposed recommendations for the triage of elective urologic surgeries. However, we must highlight that many “elective” procedures are not truly deferrable and, thus, time-sensitive. As such, any surgical delay may expose the patient to worse postoperative outcomes. Hence, aim of the current research was to provide high-level evidence supporting a risk-adapted strategy for the management of patients with localized and locally-advanced prostate cancer (PCa) amenable to robot-assisted radical prostatectomy (RARP). In particular, the study specifically examined how constraints imposed by the COVID-19 pandemic impacted surgical volume, patient outcomes, and the implementation of infection control protocols. It also evaluated the creation of a predictive model for a tailored PCa patients triage and counseling. The study design spanned three main phases, each concentrating on different aspects. Phase 1a: Evaluation of Triage Protocols for Elective Urologic Surgery During COVID-19 This phase assessed the effectiveness and safety of a triage protocol for elective urological surgeries during the COVID-19 outbreak, analyzing data from 1943 patients across various Italian centers. Not performing nasopharyngeal swab at hospital admission was independently associated to risk of developing postoperative medical complications (OR 2.3; CI 95%1.01-5.19; p=0.04) Moreover, number of patients in the facility was confirmed as an independent predictor of experiencing postoperative respiratory symptoms (OR:1.12; CI95% 1.00-1.05, p=0.047), while COVID-free facility resulted as a strong independent protective factor (OR:0.23, CI95% 0.07-0.79, p=0.02). Phase 1b: Safety and volume of RARPs during the pandemic RARP procedures could be conducted safely under pandemic conditions. Surgeries were dichotomized into two periods: during the COVID-19 pandemic (2020–2021) and the post-COVID-19 period (2022–2023). Significant reductions in surgical volume were observed during the pandemic, with 1117 surgeries performed in 2020–2021 versus 1405 in 2022–2023 (p=0.03). This difference reflects the prioritization of emergency care over elective surgeries and logistical challenges imposed by the pandemic. Laboratory confirmed COVID-19 infection during hospitalization was recorded only in 34 (3%) and 19 (1.3%) patients during pandemic and post-pandemic period, respectively (p=0.27). This demonstrates the effectiveness of preoperative screening and a controlled COVID-free surgical environment in mitigating transmission risks. Out of the 1117 patients who had surgery during the pandemic, 141 (12.6%) experienced surgery delays because of positive COVID-19 test results. Despite the challenges posed by the COVID-19 pandemic, the overall rates of surgical and medical complications, as well as rehospitalizations, remained stable across the pandemic and post-pandemic periods. While there was a slight increase in the 30-day rehospitalization rate during the COVID-19 era (5.4% compared to 4.1% in the post-pandemic period), this difference was not statistically significant (p=0.22). Phase 2: Evaluating the impact of surgical delays on cancer outcomes In this phase, the study explored the effect of pandemic-related surgical delays on oncological outcomes. Overall 2017 patients were analyzed. Low risk, intermediate risk, localized high risk and locally advanced disease were recorded in 368 (18.2%), 1071 (53.1%), 388 (19.2%) and 190 (9.4%), respectively. Median time from to diagnosis to treatment was 51 (IQR 29-70) days. Time to surgery was 56 (IQR 32-75), 52 (IQR 30-70), 45 (IQR 24-60) and 41 (IQR 22-57) days for localized low, intermediate and high risk and locally advanced disease, respectively. Considering 1827 patients with localized PCa, at multivariate analysis ISUP grade group >4 on prostate biopsy (OR: 1.30; 95% CI 1.07-1.86; p=0.02) and surgical delay only in localized high-risk disease (OR: 1.02; 95% CI 1.01- 1.54; p=0.02) were confirmed as independent predictors of pathological upstaging to pT3-T4 / pN1 disease at final histopathological examination. This finding is significant as it underscores the time-sensitive nature of cancer surgery for high-risk patients and highlights the potential consequences of deferred treatment. By contrast, patients with low- and intermediate-risk cancers experienced minimal impact from these delays, suggesting that prioritizing high-risk patients could mitigate adverse outcomes when elective surgeries must be delayed. Phase 3: Developing a Predictive Model for Biochemical Recurrence To enhance clinical decision-making during resource constraints, the study final phase focused on developing a predicting model assessing the 3-year risk of biochemical recurrence (BCF) following RARP. Multivariate analysis using Cox proportional hazards model were performed to explore predictors of 3-year BCF. We finally designed and internally validated two nomograms (pre- and postoperative), considering not only tumor-related features but also surgical delay. This model offers a practical tool for healthcare providers to prioritize patients based on their individual risk profiles, aiding in triaging patients efficiently under crisis conditions. In future pandemics or healthcare crises, such a model could help clinicians balance patient needs and healthcare system demands by assigning surgical priority based on urgency and expected outcomes. Discussion and Conclusion The study highlights the resilience of surgical oncology practices in maintaining care quality during the COVID-19 pandemic. The safety protocols established at the Careggi University Hospital, including strict COVID-19 screening and COVID-free surgical environments, allowed the continued performance of RARP with low risk of COVID-19 transmission, confirming the feasibility of essential surgical care even under pandemic conditions. The findings advocate for the adoption of a risk-adapted triage approach, where patients with the highest risk profiles receive prioritized access to surgery. This strategy not only enhances patient outcomes but also supports healthcare policy by providing a framework for resource allocation that balances infection control with timely cancer care. The study’s predictive model further adds to this approach by enabling personalized risk assessment, thus allowing hospitals to operate more effectively during future crises. Overall, this research demonstrates that while the COVID-19 pandemic significantly strained healthcare resources, well-planned protocols and tailored triage models can enable high-quality surgical care to proceed safely, especially for patients in critical need.