Study population
prostate, Prostate
MAY, PROSTATE, PROSTATE
Briefly, a prospective, blinded, randomized, multicenter clinical utility study from June 2017 to May 2018 (Decision Impact Trial of the ExoDx Prostate (IntelliScore), NCT03235687) evaluated the shared decision impact of the EPI test. This study was approved by the Institutional Review Board at Western IRB (#20171107) and conforms to the principles outlined in the Declaration of Helsinki. Inclusion criteria required that patients be men aged ≥50, with PSA 2–10 ng/mL, and without clinical history of prior biopsy scheduled for an initial prostate biopsy.