EAU guidelines do not clearly define the role of surgery in high-risk prostate cancer (PCa) patients according to the STAMPEDE definition. Although multimodal treatment (MMT) is oncologically effective, treatment intensification may increase treatment-related side effects. We aimed to evaluate the surgical safety of a STAMPEDE-like cohort of PCa patients treated with radical prostatectomy (RP) and extended pelvic lymph node dissection (ePLND).
We identified 572 PCa patients reflecting the STAMPEDE definition (cN1 or, if cN0, having at least two among: cT3-T4, ISUP 8–10, and PSA ≥40) and treated with RP+ePLND at a single centre (1990-2025). MMT was defined as the administration of neoadjuvant or adjuvant treatment. Clinical recurrence (CR) was the onset of recurrence at any site. High-grade (HG) and very HG (VHG) complications were defined as Clavien-Dindo ≥2/≥3 within 90d. The estimated annual percent change (EAPC) assessed differences in the use of MMT and HG/VHG complications across the years. Multivariable logistic regression (MLR) assessed the predictors of HG/VHG complications.
Overall, 408 (71%) patients received MMT, and 275 experienced CR. The 10-year CR-FSR was 62%. The most common recurrence sites were bones (48%), and regional nodes (24%). The most common complications were fever (13%), lymphocele (5%), and lymphedema (6%). A total of 305 (53%), 341 (60%), and 333 (58%) had lymph node invasion, pT3b/4 stage, and ISUP 4-5 at final pathology, respectively. The proportion of STAMPEDE-like patients increased, and MMT use decreased during the years (EAPC: -2.1% and +1.6%, p<0.045). Similarly, the rates of men experiencing HG and VHG complications dropped from 27% and 17% in 2016 to 22% and 3% in 2024 (EAPC: -18% and -16%, p<0.03 – Figure). Year of surgery was associated with a lower risk of HG (HR 0.80) and VHG complications (HR 0.56, p<0.03).
Despite the proportion of STAMPEDE-like patients increasing across the years, the use of MMT and the rates of complications after RP and ePLND were significantly reduced. Surgery can be safely considered as part of MMT, and clinical trial should include a surgical arms to clarify the benefit of RP in the management of very high-risk PCa.
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