Abstract B102: Recruiting underrepresented patients via centralized navigation in a decentralized registry study

Abstract Introduction: The PROMISE prostate cancer registry aimed to improve enrollment of underrepresented participants through a partnership with the Georgia Center for Oncology Research and Education (GA CORE), a non-profit organization dedicated to reducing the burden of cancer through research, education, and advocacy. Methods: Five clinical sites across Georgia, three rural community cancer centers, one urban tertiary center, and one urban private oncology group, referred minority patients with a prior prostate cancer diagnosis. A Clinical Trial Navigator (CTN) model was employed to facilitate patient referrals and guide participants through the recruitment process. The CTN provided support primarily via phone, with in-person navigation used, when possible, in urban areas. We compared demographic and clinical characteristics (age, population density, and tumor subtype) between patients who fully enrolled and those who were referred but did not complete enrollment. Results: Of 188 racially and ethnically underrepresented patients referred and navigated, 29% (n=54) fully enrolled. All fully enrolled underrepresented participants were Black, with a mean age of 67 years (range 38–95). Pathogenic variants were detected in 3 enrolled participants (5%), two of whom were Black. Variants of unknown significance (VUS) were identified in 9 participants (15%), all of whom were Black. Comparing fully enrolled versus non-enrolled underrepresented patients, younger age (p=0.017) and urban residence (p0.001) were associated with successful enrollment. Among minority participants only, urban location remained the sole significant factor (p0.001). This indicates that there was no meaningful association between younger age and full enrollment for minority patients. This contrasts a common trend in decentralized studies, where younger age is associated with greater participation. Common consent barriers among fully enrolled patients included needing help from someone other than the CTN (n=14), multiple barriers (n=6), and technology challenges (n=2). For specimen collection, primary barriers included requiring external assistance (n=12), multiple barriers (n=6), and the need for in-person CTN support (n=3). Conclusions: Urban racial and ethnic minority patients were more likely to fully enroll in the study, even with CTN support. However, centralized navigation proved effective in overcoming barriers related to literacy and technology. Additionally, among minority patients, there was no meaningful association between age and full enrollment, suggesting equitable participation across age groups. We recommend simplifying consent and specimen collection processes and expanding centralized CTN services to improve minority representation in decentralized clinical trials. Citation Format: Mele Mafi, Marquita Iddirisu, Shantoria Brown, Sheryl Gabram, Lynn Durham, Chirag Jani, Samuel Ofori, Andrew Pippas, Jay Shelton, Jayanthi Srinivasiah, Otis Brawley, Heather Cheng, Channing Paller. Recruiting underrepresented patients via centralized navigation in a decentralized registry study abstract. In: Proceedings of the 18th AACR Conference on the Science of Cancer Health Disparities; 2025 Sep 18-21; Baltimore, MD. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34(9 Suppl):Abstract nr B102.