Point-of-Care Detection of Prostate Specific Antigen

Fast-Track proposals will be accepted. Direct-to-Phase II proposals will NOT be accepted. Number of anticipated awards: 3-5 Budget (total costs, per award): Phase I: up to $400,000 for up to 12 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Page 79 Summary Among men, prostate cancer is the second leading cause of cancer mortality in the US and fifth worldwide. The largest, randomized clinical trial of prostate-specific antigen (PSA) screening (ERSPC) reported a 20% reduction in prostate cancer mortality at 16 years among screened men compared to an unscreened control group and a 30% reduction in the cumulative risk of metastases after a median follow-up of 12 years. In 1994, the FDA approved PSA testing to aid in the detection of prostate cancer. In the first 20 years following this approval, prostate cancer mortality decreased by 50%. However, after the 2012 United States Preventive Services Task Force (USPSTF) recommended against prostate cancer screening, the prostate cancer mortality curve flattened, and the incidence of metastatic disease increased. In 2018, the USPSTF recommended that men aged 55-69 years engage in shared decision-making with healthcare providers to consider the benefits and harms of PSA screening in the context of family history, race, comorbid medical conditions, values, and preferences. The National Comprehensive Cancer Network, American Urology Association, and the American Cancer Society recommend that men discuss the pros and cons of PSA screening with their healthcare provider, starting at age 40 to 55 years. The prostate cancer mortality rate is high among African American men, who face disproportionately greater barriers to health care services, including cancer screening, compared to the general population. Decision analysis models suggest that PSA-based screening may provide greater benefit to African American men. Therefore, greater adoption of PSA screening in African American and other high-risk men has the potential to reduce the burden of cancer treatment by increasing the detection of disease amenable to curative therapy (when indicated) or surveillance (when appropriate). The development of an accurate, inexpensive home test for PSA is both an unmet need and an NCI priority in the context of President Biden's Moonshot goal of reducing cancer mortality by half within 25 years. While the availability of home or point-of-care testing cannot overcome structural impediments to screening, the knowledge that one has an elevated PSA would remove a substantial barrier to screening by helping men prioritize this issue. This topic is aligned with the Cancer Moonshot Blue Ribbon Panel recommendation to expand the use of proven cancer prevention and early detection strategies (G).