A comparison of prostate health index, total PSA, %free PSA, and proPSA in a contemporary US population: the MiCheck-01 prospective trial

Neal D. Shore*, Christopher M. Pieczonka, R. Jonathan Henderson, James L. Bailen, Daniel R. Saltzstein, Raoul S. Concepcion, Jennifer L. Beebe-Dimmer, Julie J. Ruterbusch, Thao Ho Le, Rachel A. Levin, Sandra Wissmueller, Philip Prah, Robert Borotkanics, Thomas A. Paivanas, Arletta van Breda, Douglas H. Campbell, Bradley J. Walsh

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

5 Citations (Scopus)


Background: Increasing numbers of patients are presenting with aggressive prostate cancer (CaP); therefore, there exists a need to optimally identify these patients pre-biopsy. Objectives: To compare the accuracy of total prostate specific antigen (PSA), %free PSA, and prostate health index (PHI) to differentiate between patients without CaP, with non-aggressive (Gleason 3 + 3, non-AgCaP) and with aggressive (Gleason ≥ 3 + 4, AgCaP) in a contemporary US population. Design, settings, and participants: Serum samples were collected from 332 US patients scheduled for biopsy due to an elevated age-adjusted PSA. Site and Central biopsy pathologic assessment were performed. Outcome measurements and statistical analysis: Testing of PSA, free PSA, proPSA, and PHI was performed along with central pathology review. Test performance using logistic regression analysis for differentiating CaP from non-CaP as well as non-AgCaP from AgCaP was evaluated. Results and limitations: Central pathology review resulted in 32 upgrades including 14 Gleason 3 + 3 scores being upgraded to AgCaP with final distribution of 148 no-CaP, 64 non-AgCaP, and 120 AgCaP patients. Receiver operator curve (ROC) analysis of the different tests showed that PHI performed best at differentiating CaP from no-CaP subjects (area under the receiver operator curve 0.79). In contrast, the different tests were essentially equivalent in differentiating AgCaP vs. non-AgCaP. Conclusions: In this recent US study of prebiopsy patients we observed a high proportion of AgCaP patients consistent with previous studies in contemporary US populations. Central Gleason review is recommended for multi-institutional studies comparing biomarkers. PHI was superior to PSA, free PSA, %free PSA, and proPSA in detecting CaP in this population but was not superior at differentiating AgCaP from non-AgCaP.

Original languageEnglish
Article number683
Pages (from-to)683.e1-683.e10
Number of pages10
JournalUrologic Oncology: Seminars and Original Investigations
Issue number8
Early online date30 Apr 2020
Publication statusPublished - Aug 2020
Externally publishedYes


  • Aggressive
  • Biomarker
  • Clinical study
  • Prostate


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