Presentation (CTI)

OBJECTIVES: Prostate cancer affects millions of men across diverse races, ethnicities, and socioeconomic backgrounds. Yet many prostate cancer research studies do not adequately represent the diversity of this population. To address this gap, we developed a data-driven strategy to promote equitable patient enrollment. Specifically, we demonstrate how incorporating race/ethnicity targets and supporting methods into the study protocol impacts the ability to enroll an equitably representative patient population.
METHODS: The PYLARIFY Registry (NCT 05712473), conducted under SoNaR, Specialty Networks Registry, is a United States (US) based multi-center prospective 5-year observational study following patients receiving standard-of-care piflufolastat F18 imaging for prostate cancer management. National data sources were analyzed to establish patient enrollment targets, including race/ethnicity distributions, to reflect the US prostate cancer population. Potential study sites were evaluated for patient demographics and selected to meet enrollment goals. Enrollment was monitored to provide feedback to the sites if the observed enrollment trends deviated from the target. Subjects were grouped for analysis using chi-square testing to compare enrolled against targeted racial/ethnic proportions.
RESULTS: 480 out of 500 total subjects (96%) have been enrolled to date across 22 sites in diverse US regions. At present, the race/ethnic distribution versus target is: Black men 18% versus 13% target, Hispanic or Latino men 9% versus 14% target, non-Hispanic White men 66% versus 64% target, and other 8% versus 9% target. Notwithstanding race/ethnicity category variations within minority (non-White) groups, enrollment proportions remained aligned with targets: 66% White and 34% non-White (p=0.458).
CONCLUSIONS: Interim results from the PYLARIFY Registry demonstrate that proactive planning with pre-set enrollment targets and active communication with study sites can help achieve equitable enrollment in prostate cancer research. Future research utilizing this approach will support more representative patient cohorts and research findings that are applicable to the general prostate cancer patient population.