Potential Utility of Prostate Health Index Density for Prostate Cancer Detection and Prediction in Korean Men: A Prospective Multicenter Study

Abstract

Purpose We evaluated the clinical performance of Prostate Health Index (PHI) density with [-2]proPSA (p2PSA) and its derivatives in predicting the presence of prostate cancer (PCa) in Korean men. Materials and Methods A total of 706 men with total prostate-specific antigen (tPSA)≥2.5 ng/mL who underwent their first prostate biopsy were included in this prospective, multicenter, observational study. Diagnostic accuracy of tPSA, free-to-total PSA ratio (%fPSA), p2PSA, %p2PSA, the Beckman Coulter PHI, and PHI density was assessed by receiver operating characteristic curve analyses and logistic regression analyses. PHI was calculated as [(p2PSA/free PSA)×tPSA½], and density calculations were performed using prostate volume as determined by transrectal ultrasonography. Results Overall, PCa was detected in 367 of all subjects (52%). In men with tPSA 2.5–10 ng/mL, the detection rate of PCa was 41.1% (188 of 457). In this group, PHI and PHI density were the most accurate predictors of PCa and significantly outperformed tPSA and %fPSA; area under the curve for tPSA, %fPSA, %p2PSA, PHI, and PHI density was 0.58, 0.68, 0.70, 0.75, 0.73 respectively. PHI and PHI density were also the strongest predictor of PCa with Gleason score ≥7. Conclusions Based on the present prospective multicenter experience, PHI and PHI density demonstrate the superior clinical performance in predicting the presence of PCa in Korean men with tPSA 2.5–10 ng/mL. Key Words: Biomarkers; Biopsy; Early diagnosis; Prostatic cancer; Prostate-specific antigen; Protein isoforms.