Clinical trials are fundamental to evidence-based medicine, as they employ rigorous scientific methods to evaluate the efficacy and safety of new therapies aimed at preventing or treating diseases, including cancer. Successful completion of these trials relies heavily on participant enrollment. Although over 70% of Americans express willingness to participate in clinical trials, fewer than 5% of adult cancer patients actually enroll, highlighting a substantial gap between intent and participation. This challenge is evident in trials involving men with prostate cancer (PCa) on active surveillance (AS), where the target population is predominantly over 50 years old, and recruitment and enrollment difficulties have been widely reported. Current participation rates for men in primary and secondary chemoprevention trials remain unknown. Moreover, unforeseen environmental events, such as pandemics or natural disasters that disrupt the economy, personal circumstances, travel, or in-person study procedures, underscore the importance of continuously identifying recruitment obstacles and developing solutions to ensure the timely completion of early-phase chemoprevention trials. Evidence from recent studies indicates that cancer prevention trials were disproportionately affected by the pandemic compared to treatment trials. This manuscript aims to share our experience in systematically assessing both protocol- and patient-level barriers to recruiting men on AS for PCa within a chemoprevention trial at the Comprehensive Cancer Center (CCC), while describing the current strategies employed to sustain enrollment. Using data from our ongoing trial as an example, we discuss approaches to enhance clinical trial recruitment overall, which may guide the design of future cancer chemoprevention studies and help prioritize strategies that efficiently target and engage the intended population.
