Evaluating global disparities in access to prostate cancer clinical trials.

132 Background: Prostate cancer (PCa) has the second highest incidence among cancers in men and accounts for 7% of all cancer-related deaths in this population (Globocan 2022). Clinical trials (CTs) are essential to improve patient care, and were responsible for an increase of 6 months in overall survival for metastatic PCa in the past decade (JNO 2023). However, CT availability often varies between countries, in spite of the local burden of disease (Barragan-Carrillo ASCO GU 2025). We aimed to assess the current global availability of PCa CTs and the factors impacting it. Methods: We reviewed all PCa CTs from 6/1/2019 to 6/1/2024 through clinicaltrials.gov. Trials without PCa patients or non-interventional were excluded. Countries with at least one site were classified according to the World Bank Ranking (WBR) as high, upper-middle, lower-middle, and low-income countries (HIC, UMIC, LMIC and LIC). Additionally, we collected data on trial sponsor, funding, phase and cancer stage to summarize the characteristics of each trial. Logistic regression was used to evaluate the association between PCa trial availability and WBR, incidence, mortality, health expenditure, and gross national income (GNI). Results: Out of 1531 identified trials, 1413 met the eligibility criteria. HICs had greater odds of having CT access compared to non-HICs (OR = 8.44, 95% CI: 4.10–17.41, p < .001), with the majority of CTs conducted exclusively in HICs (80.4%). Most trials were early phase (54.6%) and included patients with metastatic disease (55.4%). Studies were primarily sponsored by academia (68.8%), followed by pharma (26.8%), with industry-funded trials having a higher number of countries involved (mean 2.7 vs 1.04, p < .001). Logistic regression analysis revealed that GNI, annual health expenditure, and incidence rates were all significantly associated with increased odds of CT availability (p < .001), whereas higher cancer mortality rates were associated with reduced odds of CT access (OR = 0.95, 95% CI: 0.91–0.99, p = .009). Conclusions: PCa trials are disproportionately concentrated in HICs despite lower burden of disease, and are closely tied to both GNI and health spending. Notably, CTs funded by pharma were more likely to be multinational, and might represent a pathway to increase CTs availability in non-HICs. To ensure equitable advances in PCa care, it is critical to expand trial access in underrepresented regions.