In 1989, researcher William J. Catalona, MD of Washington University – St. Louis began a study that established the PSA blood test as prostate cancer (PCa) screening tool.

In 1991, Catalona showed that PSA could be used as a first-line screening test for PCa in men without suspicious DRE findings. Subsequently, PSA testing was widely adopted, causing a spike in PCa incidence rates, as the inventory of previously undetectable PCa was unmasked. This led to the creation of a new clinical-stage classification (T1c), i.e., PCa with a normal DRE that has become the most common stage in practice.

PCa is the third-leading cause of cancer death in men, with an estimated 161,360 new cases being diagnosed in 2017, and 26,730 projected cancer deaths. PCa seldom produces symptoms until it is incurable, and currently-available methods cannot accurately distinguish between tumors that will progress so slowly that they will not produce symptoms and those that are likely to cause suffering or death.