Usefulness of the prostate health index in predicting the presence and aggressiveness of prostate cancer among Korean men: a prospective observational study

Abstract

Background We aimed to evaluate the usefulness of the Beckman Coulter prostate health index (PHI) and to compare it with total prostate-specific antigen (PSA) levels and related derivatives in predicting the presence and aggressiveness of prostate cancer (PCa) in the Korean population. Methods A total of 140 men who underwent their first prostate biopsy for suspected PCa were included in this prospective observational study. The diagnostic performance of total PSA, free PSA, %free PSA, [–2] proPSA (p2PSA), %p2PSA, and PHI in detecting and predicting the aggressiveness of PCa was estimated using the receiver operating characteristic curve (ROC) and logistic multivariate regression analyses. Results Of 140 patients, PCa was detected in 63 (45%) of participants, and 48 (76.2%) of them had significant cancer with a Gleason score (GS) ≥ 7. In the whole group, the area under the curve (AUC) for ROC analysis of tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.63, 0.57, 0.69, 0.69, 0.72, and 0.76, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p = 0.005). For PCa with GS ≥ 7, the AUCs for tPSA, free PSA, %fPSA, p2PSA, %p2PSA, and PHI were 0.62, 0.58, 0.41, 0.79, 0.86, and 0.87, respectively, and the AUC was significantly greater in the PHI group than in the tPSA group (p < 0.001). In the subgroup with tPSA 4–10 ng/mL, both %p2PSA and PHI were strong independent predictors for PCa (p = 0.007, p = 0.006) and significantly improved the predictive accuracy of a base multivariable model, including age, tPSA, fPSA and %fPSA, using multivariate logistic regression analysis. (p = 0.054, p = 0.048). Additionally, at a cutoff PHI value > 33.4, 22.9% (32/140) of biopsies could be avoided without missing any cases of aggressive cancer. Conclusions This study shows that %p2PSA and PHI are superior to total PSA and %fPSA in predicting the presence and aggressiveness (GS ≥ 7) of PCa among Korean men. Using PHI, a significant proportion of unnecessary biopsies can be avoided.

Current prostate cancer screening and treatment strategies may not support a holistic nationwide program

“…The Beckman Coulter Prostate Health Index (PHI) gives a more accurate result, further rules out false-positive test results for men with high PSA levels, and provides a better understanding of the aggressiveness of the disease. [20][21][22] However, it is validated only within total PSA levels ranging from 4 to 10 ng/ml; this is a major downside because three fourths of men with PSA levels within this range may not have prostate cancer. 23 Although PSA has been the gold standard for detecting prostate cancer, its shortcoming lies in its high sensitivity and very low specificity.…”

“…34,35 More recent studies in China and Korea have suggested possible health economic benefits of adopting the PHI test for prostate cancer screening. 20,36 However, there is skepticism over its use in the United Kingdom. 37,38 This could be mainly due to inadequate research into its applicability in the UK population.…”

“…Furthermore, developed nations such as the United States, Australia, and some countries of Europe have moved toward implementing the use of the PHI in their national guidelines for prostate cancer screening 34,35 . More recent studies in China and Korea have suggested possible health economic benefits of adopting the PHI test for prostate cancer screening 20,36 . However, there is skepticism over its use in the United Kingdom 37,38 .…”

The Clinical Usefulness of Prostate Cancer Biomarkers: Current and Future Directions

“…The AUC for PHI in the overall group was 0.76 (which was higher than tPSA, fPSA, %fPSA) and in the sub-group with GS ≥ 7, a value of 0.87 was obtained. PHI was a strong independent prognosticator of PCa particularly for the presence and aggressiveness (GS ≥ 7) of the disease, and its application could prevent a substantial amount of unnecessary prostate biopsies [77]. Furthermore, there are other recent studies that have demonstrated that PHI is more specific than tPSA in PCa detection [78] and a better predictor than %fPSA in detecting PCa at prostate biopsy [79].…”

Comparisons of the diagnostic accuracy across prostate health index, prostate health index density, and percentage free prostate-specific antigen for clinically significant prostate cancer: a prospective diagnostic study

“…The isoform [-2]proPSA (p2PSA), which is a truncated variant of proPSA, is a relatively new serum marker for the early diagnosis of PCa (7). P2PSA derivatives, percentage of p2PSA (%p2PSA) and prostate health index (PHI), are calculated based on p2PSA and are superior to free PSA (fPSA) in diagnosing and predicting PCa (8,9).…”