P237: Learned Lessons from a US-wide outreach program to expand enrollment to the decentralized PROMISE Registry
Poster Presenter
Amanda McMannis
Associate Director, Clinical Operations
The Prostate Cancer Clinical Trials Consortium United States
Objectives
PROMISE (NCT04995198) is a US prospective decentralized prostate cancer genetic registry that aims to expand enrollment beyond academic centers through an outreach program. It aims to enroll 5,000 patients, offering germline testing to identify 500 with mutations of interest for long-term follow-up.
Method
Launched in 2021, the outreach program has expanded PROMISE to those treated in community settings. Efforts include outreach via advocacy groups, online and in-person events, and state registry letters. Strategies to boost diversity include clinic tablets, local partnerships, and trial education.
Results
As of February 2025, overall study accrual is 59% ahead of initial projections and identification of individuals with germline mutations in genes of interest is 20% ahead of initial projections. 5,858 have been enrolled and 412 who were found to have pathogenic/likely pathogenic mutations or variants of uncertain significance (VUS) in genes of interest are eligible for long-term follow-up across 50 states, with most enrollment occurring on the East and West Coasts. Self-reported race/ethnicity distribution of all participants enrolled, of which multiple responses may be selected, is as follows: American Indian or Alaska Native 0.9%, Asian 2.5%, Black 6.2%, Hispanic 2.3%, Native Hawaiian or Pacific Islander 0.1%, White 72.9%, unknown 0.2%, and no response provided 16.5%.
Conclusion
Traditional recruitment efforts by clinical trial sites, when supplemented with direct-to-patient outreach yield increased study enrollment. Effective components include 1) partnerships with prostate cancer patient advocacy organizations, 2) communication from principal investigators, investigators, and other medical professionals via webinars and interviews with clinically relevant topics and Q&A, and 3) diverse methods of outreach. Online marketing and integrated campaigns with marketing partners were important factors in the success of the outreach program. While the registry has continued to have high accrual due to the outreach efforts in place, the diversity and distribution of patients’ race and ethnicity continues to be a challenge for enrollment. The PROMISE study team continues to work with outreach partners to identify and engage with a greater number of diverse communities and recruit patients with prostate cancer who would benefit from receiving genetic testing through the PROMISE Registry.
