e23426 Background: Darolutamide (DARO) has demonstrated efficacy and a tolerable safety profile in prostate cancer (PC) clinical trials spanning nonmetastatic castration-resistant PC (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), resulting in FDA approval. Real-world evidence of DARO utilization, however, remains limited. Here we summarize patient characteristics and utilization patterns of DARO across the PC spectrum among a national cohort of United States Veterans treated in the Department of Veterans Affairs (VA). Methods: We conducted a retrospective, observational study among Veterans with advanced PC diagnosed from January 2019 through December 2024. This cohort was identified from the Veterans Health Administration’s Corporate Data Warehouse. Patients were indexed into the study at first initiation of DARO. Advanced PC was defined as diagnosis with mCSPC, nmCRPC, or metastatic castration-resistant PC (mCRPC). Analyses of these disease states were operationalized through analysis of structured data (e.g., prostate-specific antigen values) and unstructured data (e.g., clinical notes). Veterans were included in this analysis if treatment with DARO was initiated after diagnosis of advanced PC. The follow-up period extended for a minimum of 2 months after index or until patient’s date of death, the final date of activity in database, or the end of the study period. Use of androgen deprivation therapy (ADT) and/or docetaxel alongside DARO was examined. Results: 1,729 Veterans with advanced prostate cancer and who had DARO ± ADT during the study period were identified. These Veterans were 57.7% White, 27.1% Black, 5.3% Hispanic and 9.9% Other or Unknown. 75.6% resided in urban locations with a median age of 75 yrs. At the time of treatment initiation, 783 (45.3%) were diagnosed with mCSPC, 301 (17.4%) were diagnosed with nmCRPC, and 645 (37.3%) were diagnosed with mCRPC. No notable differences in patient characteristics were observed between these clinical subgroups. Among the veterans treated with DARO ±ADT, 198 (11.5%) Veterans received DOCI therapy concomitantly and of this, 153 (77.3%) had mCSPC. Conclusions: Our findings suggest that DARO is increasingly utilized in advanced PC. Our results suggest that VA physicians are prescribing DARO in mCSPC and mCRPC as off-label indication, potentially reflecting confidence in its efficacy and favorable safety profile.
Mcshinsky et al. (Thu,) studied this question.