Evaluation of toxicity profiles of next-generation androgen receptor pathway inhibitors in the geriatric population: Analysis of the FAERS (FDA Adverse Event Reporting System) database.

206 Background: The use of next-generation ARPIs in combination with ADT has revolutionized the treatment of prostate cancer. However, toxicity data remain limited, particularly in the geriatric population. The aim of this study was to evaluate the age-related toxicity profile of ARPIs to guide personalized treatment selection. Methods: This retrospective study was conducted using data from the FAERS (2015–2025). After deduplication per FDA guidance, 14,526,785 unique reports were retained. Male prostate cancer cases aged ≥18 years in which an ARPIs —enzalutamide, apalutamide, darolutamide, abiraterone— was listed as the primary suspect drug were included (n = 33,076). Adverse events were classified using Standardised MedDRA Queries (SMQs, MedDRA v28.1), which group clinically related preferred terms into hierarchical categories. Malignancy-related SMQs were excluded to avoid indication bias. Disproportionality analyses were performed using Reporting Odds Ratios (RORs) to detect significant positive signals (lower 95% CI >1). SMQs meeting this threshold were further assessed by univariate logistic regression for age-specific risk (% of events for total population,