Background and objective: Radiotherapy (RT) is a key curative option for localized prostate cancer (PC). However, data on late genitourinary toxicity, especially adverse events requiring urgent care or hospitalization, remain limited. The aim of the Italian Registry of Radiotherapy-Associated Disorders and Urological Treatment & Evaluation (IRRADIaTE) is to characterize the burden and management of severe genitourinary adverse events following prostate RT across multiple high-volume centers in Italy. Methods: A prospe across 20 Italian in ctive, observational, multicenter registry was established in 2024 stitutions. Men with localized PC previously treated with curative, adjuvant, or salvage RT who presented with late (>= 6 mo) genitourinary complications requiring urgent medical attention were enrolled. Demographics, treatment details, and outcomes were collected. Toxicity grading followed Common Terminology Criteria for Adverse Events. of grade 3-5 events Primary endpoints were prespecified as (1) the cumulative incidence with death as a competing risk and (2) hospitalization-free survival from RT completion. founders only. Key findings and limitations_ Among 321 patients, 50% received primary RT, and 50% postprostatectomy RT. A t the time of admission, 43% presented with grade 3-5 genitourinary toxicity. Over to 42%. Higher cumulative incidence of severe events was observed in the primary RT group. The percentage o related complications de 12 mo after RT to 66% (95 bidity profiles between t registry enrolls only me and causal effects cannot Analyses were descriptive and adjusted for prespecified con-5 yr, the hospitalization-free survival rate declined from 86% f patients who did not require major surgery to manage RTcreased from 81% (95% confidence interval [CI] 76-97%) at % CI 48-79%) at 60 mo. Differences in baseline age and comorhe RT treatment settings must be acknowledged. Because the n presenting with complications, population-level incidence be inferred. Conclusions and clinical implications_ Late genitourinary toxicity after prostate RT is source-intensive. Differences observed by treatment setting tion of causal mechanisms and treatment effects requires dedtudies. substantial and often re are associational; attribu icated causal-inference s (c) 2026 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an ope n access article under the CC BY-NC-ND license (http://creative-commons.org/licenses/by-nc-nd/4.0/).
Real-World Burden and Management of Late Genitourinary Toxicity After Prostate Radiotherapy: Insights from IRRADIaTE, the Italian Registry of Radiotherapy-Associated Disorders and Urological Treatment & Evaluation
Bertolo, Riccardo
;Malandra, Sarah;Antonelli, Alessandro
2026-01-01
Abstract
Background and objective: Radiotherapy (RT) is a key curative option for localized prostate cancer (PC). However, data on late genitourinary toxicity, especially adverse events requiring urgent care or hospitalization, remain limited. The aim of the Italian Registry of Radiotherapy-Associated Disorders and Urological Treatment & Evaluation (IRRADIaTE) is to characterize the burden and management of severe genitourinary adverse events following prostate RT across multiple high-volume centers in Italy. Methods: A prospe across 20 Italian in ctive, observational, multicenter registry was established in 2024 stitutions. Men with localized PC previously treated with curative, adjuvant, or salvage RT who presented with late (>= 6 mo) genitourinary complications requiring urgent medical attention were enrolled. Demographics, treatment details, and outcomes were collected. Toxicity grading followed Common Terminology Criteria for Adverse Events. of grade 3-5 events Primary endpoints were prespecified as (1) the cumulative incidence with death as a competing risk and (2) hospitalization-free survival from RT completion. founders only. Key findings and limitations_ Among 321 patients, 50% received primary RT, and 50% postprostatectomy RT. A t the time of admission, 43% presented with grade 3-5 genitourinary toxicity. Over to 42%. Higher cumulative incidence of severe events was observed in the primary RT group. The percentage o related complications de 12 mo after RT to 66% (95 bidity profiles between t registry enrolls only me and causal effects cannot Analyses were descriptive and adjusted for prespecified con-5 yr, the hospitalization-free survival rate declined from 86% f patients who did not require major surgery to manage RTcreased from 81% (95% confidence interval [CI] 76-97%) at % CI 48-79%) at 60 mo. Differences in baseline age and comorhe RT treatment settings must be acknowledged. Because the n presenting with complications, population-level incidence be inferred. Conclusions and clinical implications_ Late genitourinary toxicity after prostate RT is source-intensive. Differences observed by treatment setting tion of causal mechanisms and treatment effects requires dedtudies. substantial and often re are associational; attribu icated causal-inference s (c) 2026 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an ope n access article under the CC BY-NC-ND license (http://creative-commons.org/licenses/by-nc-nd/4.0/).
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