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Serum marker %[‐2]proPSA and the Prostate Health Index improve diagnostic accuracy for clinically relevant prostate cancer

Serum samples from patients with prostate cancer (PCa) are measured routinely for total PSA (tPSA) and complexed PSA as a part of the diagnostic evaluation. In addition, a variety of molecular isoforms of the PSA molecule can be assayed, including free PSA (fPSA), %freePSA, [-2]proPSA, %[-2] proPSA and the new combined calculation, termed the Prostate Health Index (PHI), which is calculated using [-2] proPSA, fPSA and tPSA. The PHI was developed by Beckman Coulter immunoassays and is performed on Access-2or DxI800-instruments. Numerous clinical studies have been conducted with the isoforms of PSA (fPSA, %fPSA, [-2] proPSA and %[-2]ProPSA) to test the PCa diagnosis and prognosis predictions, and to predict the need for rebiopsies [1]. In addition to these various molecular isoforms of US Food and Drug Administration-approved clinical bioassays for PSA, several PSA-computed derivatives have also been developed to assess kinetics such as PSA velocity, PSA density and PSA doubling time, and all of these tests have been used to evaluate mostly prognostic events (i.e. disease progression, metastasis and death) in patients with PCa [2].