Presentation (CTI)

OBJECTIVES: Prostate cancer (PCa) is a leading cause of cancer-related death among men in the United States (U.S.), posing a major burden on healthcare systems and communities. Despite the importance of clinical trials in advancing PCa treatments, limited evidence exists on the factors influencing trial participation. This study examined patient- and county-level characteristics associated with clinical trial participation among U.S. men diagnosed with PCa.
METHODS: This retrospective claims-based analysis utilized the Medicare 5% Standard Analytical Files to identify men aged 65+ with an encounter for PCa from 1/1/2016-12/31/2022. Clinical trial participation was defined by the presence of International Classification of Diseases, Tenth Revision diagnosis code Z00.6. To approximate the total Medicare Fee-for-Service population, patient counts from the 5% sample were extrapolated using a standard multiplier of 20. Patient records were then linked to county-level social determinants of health (SDOH) data from the 2020 Agency for Healthcare Research and Quality (AHRQ) database.
RESULTS: A total of 2,368,280 PCa patients were identified, with a mean age of 75.1 years, a mean Charlson Comorbidity Index (CCI) score of 5.6, and a predominantly White demographic (81.9%). Among this cohort, 104,040 patients (4.4%) participated in clinical trials. Compared to non-participants, trial participants had higher mean CCI scores (7.1 vs. 5.5, p<0.001) and were more likely to be White (88.9% vs. 81.7%, p<0.001). County-level SDOH factors were also significantly associated with trial participation, with a greater proportion of participants residing in counties with a median home value ≥$348,000 (25.3% vs. 21.8%), a median household income ≥$85,081 (19.0% vs. 16.9%), or a metro area designation (84.9% vs. 81.8%) compared to non-participants (all p<0.001).
CONCLUSIONS: Demographic, socioeconomic, and geographic disparities exist in clinical trial participation among patients with PCa. Efforts to integrate diverse patient populations into clinical trials are essential to ensure equitable treatment access and patient outcomes.