Cited 37 times since 2012 (2.9 per year) source: EuropePMC The Journal of urology, Volume 189, Issue 5, 30 5 2012, Pages 1702-1706 Prospective multicenter evaluation of the Beckman Coulter Prostate Health Index using WHO calibration. Loeb S, Sokoll LJ, Broyles DL, Bangma CH, van Schaik RH, Klee GG, Wei JT, Sanda MG, Partin AW, Slawin KM, Marks LS, Mizrahi IA, Shin SS, Cruz AB, Chan DW, Roberts WL, Catalona WJ

Purpose

Reported prostate specific antigen values may differ substantially among assays using Hybritech® or WHO standardization. The Beckman Coulter® Prostate Health Index and [-2]proPSA are newly approved serum markers associated with prostate cancer risk and aggressiveness. We studied the influence of assay standardization on these markers.

Materials and methods

Prostate specific antigen, percent free prostate specific antigen and [-2]proPSA were measured using Hybritech calibration in 892 men from a prospective, multicenter study undergoing prostate biopsy. We calculated the Prostate Health Index using the equation, ([-2]proPSA/free prostate specific antigen) × PSA. Index performance characteristics for prostate cancer detection were then determined using recalculated WHO calibration prostate specific antigen values.

Results

The median Prostate Health Index was significantly higher in men with prostate cancer than in those with negative biopsies using WHO values (47.4 vs 39.8, p <0.001). The index offered improved discrimination of prostate cancer detection on biopsy (AUC 0.704) compared to percent free or total prostate specific antigen using the WHO calibration.

Conclusions

The Prostate Health Index can be calculated using Hybritech or WHO standardized assays. It significantly improved prediction of the biopsy outcome over that of percent free or prostate specific antigen alone.

J Urol. 2012 11;189(5):1702-1706