EDITORIAL COMMENT

Abstract

The authors report on the largest clinical evaluation of Prostate Health Index (PHI) assay in African American (AA) men for the prediction of Gleason grade group (GG) 2-5 prostate cancer (PCa). 1 Morris K Kotamarti S Polascik T Moul J. Re-thinking how we use prostate health index for African American Men. Urology. 2023; (S0090-4295(23)00176-0) Abstract Full Text Full Text PDF Scopus (0) Google Scholar They report that the required threshold to achieve a sensitivity >90% coincides with a poor specificity; this only permits 4.7% of Black men to avoid a biopsy even though over half of biopsies were negative or GG 1 PCa. Their findings call in to question whether the assay is accurate enough to be relied upon for Black men. There is, however, a potential for bias from its retrospective and heterogeneous nature. The fact that 18.2% of men did not proceed to biopsy, 36.4% had prostate Magnetic Resonance Imaging (MRI), 13.4% had a fusion biopsy and men were seen in a tertiary care setting could enrich the population for any PCa and GG 2-5 PCa and overestimate risk for each stratum, including the 0-26.9 strata where the authors detected any PCa (48.0%) in 13 of 22 fusion biopsy patients. A biopsy-naïve/MRI-naïve cohort would be a better comparator, since the risk strata that PHI uses is based on a cohort that predates the use of MRI Prostate Imaging–Reporting and Data System (PIRADS) scores. 2 Catalona WJ Partin AW Sanda MG et al. A multi-center study of [− 2] pro41 prostate-specific antigen (PSA) in combination with PSA and free PSA for prostate cancer detection in the 2.0 to 10.0 ng/mL PSA range. J Urol. 2011; 185: 1650 Crossref PubMed Scopus (375) Google Scholar ,3 Barentsz JO Richenberg J Clements R et al. ESUR prostate MR guidelines 2012. Eur Radiol. 2012; 22: 746-757 Crossref PubMed Scopus (1906) Google Scholar Nevertheless, it shows that the value of PHI in a ‘real-world’ setting may be limited. Their findings also dovetail with the study on Black men with elevated prostate-specific antigen (PSA) by Babajide et al where the probability of overall and GG 2-5 PCa were higher at each of the established PHI risk strata. 4 Babajide R Carbunaru S Nettey OS et al. Performance of prostate health index in biopsy naïve black men. J Urol. 2021; 205: 718-724 Crossref PubMed Scopus (9) Google Scholar Data in other racial groups also suggests that optimal thresholds of PHI vary across populations. 5 Tan LG Tan YK Tai BC et al. Prospective validation of %p2PSA and the prostate health index, in prostate cancer detection in initial prostate biopsies of Asian men, with total PSA 4-10 ng ml-1. Asian J Androl. 2017; 19: 286-290 Crossref PubMed Scopus (27) Google Scholar , 6 Ferro M Bruzzese D Perdona S et al. Prostate Health Index (PHI) and Prostate Cancer Antigen 3 (PCA3) significantly improve prostate cancer detection at initial biopsy in a total PSA range of 2–10 ng/ml. PLoS One. 2013; 8: e67687 Crossref PubMed Scopus (87) Google Scholar , 7 Loeb S Sanda MG Broyles DL et al. The prostate health index selectively identifies clinically significant prostate cancer. J Urol. 2015; 193: 1163-1169 Crossref PubMed Scopus (197) Google Scholar