Time to replace prostate‐specific antigen (PSA) with the Prostate Health Index (PHI)? Yet more evidence that the PHI consistently outperforms PSA across diverse populations

Abstract

The Prostate Health Index (PHI) has regulatory approval in >50 countries worldwide and is now being incorporated into prostate cancer guidelines; for example, the 2014 National Comprehensive Cancer Network Guidelines for early prostate cancer detection discuss the PHI as a means to improve specificity, using a threshold score of 35 [1]. The PHI is also discussed in the Melbourne Consensus Statement [2], and it has been incorporated into the multivariable Rotterdam risk calculator smartphone app for use in point-of-care decisions [3].As the use of this test continues to expand, more data on its performance in specific at-risk populations are of great interest. The investigators from the PROMEtheus multicentre European trial have previously validated the use of the PHI in men with a positive family history of prostate cancer [4] Among the 965 participants in the PROMEtheus study, 14.7% were considered obese based on a body mass index ≥30 kg/m 2 . In this group, 45.8% were diagnosed with prostate cancer from a ≥12-core biopsy, and 67.7% had a Gleason score ≥7. Overall, the PHI significantly outperformed PSA for prostate cancer detection in men with a body mass index ≥30 kg/m 2 (area under the curve 0.839 vs 0.694; P < 0.001). At 90% sensitivity, the threshold for PHI in obese men was 35.7, with a specificity of 52.3%. The PHI also had the best performance for the detection of Gleason ≥7 disease, with an area under the curve of 0.89.These findings add to the highly consistent body of evidence supporting the use of the PHI in early prostate cancer detection and risk stratification. In fact, all published studies to date have shown that the PHI outperforms PSA for detection of overall and high-grade prostate cancer detection on biopsy [6]. Numerous studies have also shown a role for the PHI in patient selection and monitoring during active surveillance [7,8]. Expanded use of this test is warranted to reduce unnecessary biopsies and better identify cancers with life-threatening potential.

Prostate biopsy decisions: one‐size‐fits‐all approach with total PSA is out and a multivariable approach with the Prostate Health Index is in

“…These findings are exactly what we would expect, as studies have consistently shown that the PHI outperforms PSA [2,6]. Other groups from the European Randomized Study of Screening for Prostate Cancer (ERSPC) have also integrated the PHI into multivariable risk prediction through the development of a user-friendly smartphone app called the Rotterdam Risk Calculator [7].…”

Influence of age on seven putative prostate tumor markers: a cohort study in Chinese men

“…The tPSA levels of 22 (4.62%) men showed an abnormal level (above 10 ng ml −1 ), and those of 12 (2.52%) men were found to be in the diagnostic gray zone (4.0–10.0 ng ml −1 ) 34. These 34 men were excluded from the present study and were referred for further extensive medical diagnostics or long-term follow-up.…”

“…In general, elderly patients experience a higher incidence of PCa, which has become the second leading cause of death in some countries 34. As a result, research efforts toward screening and early detection of PCa have increased greatly.…”

“…Recent reports suggest that new indicators such as %p2PSA (isoform [-2]proPSA) and the prostate health index (PHI) have better clinical value than conventional PSA alone 34. However, there is a lack of studies on these potential markers, and the reasons for using %p2PSA and PHI have not been clarified.…”

Comparative Study of Blood-Based Biomarkers, α2,3-Sialic Acid PSA and PHI, for High-Risk Prostate Cancer Detection

“…PHI score has been reported to correlate with PSA serum levels and Gleason scores. Nowadays, PHI has regulatory approval in more than 50 countries worldwide and is now being incorporated into prostate cancer guidelines for early prostate cancer detection and risk stratification [18]. However, others studies do not completely agree with these results and indicated that when the goal is to detect at least 95% of the aggressive tumors, PHI does not seem to be much more effective than the %fPSA and the PSA density [19].…”