Diagnostic Performance of %[-2]proPSA and Prostate Health Index for Prostate Cancer: Prospective, Multi-institutional Study

J Korean Med Sci. 2018 Mar 12;33(11):e94. doi: 10.3346/jkms.2018.33.e94.

Abstract

Background: We evaluated the clinical performance of [-2]proPSA (p2PSA) and its derivatives in predicting the presence and aggressiveness of prostate cancer (PCa) in Korean men.

Methods: A total of 246 men with total prostate-specific antigen (tPSA) ≥ 3.5 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, and the Beckman Coulter prostate health index (PHI) was assessed by receiver operating characteristic curve analyses and logistic regression analyses.

Results: Overall, PCa was detected in 125 (50.8%) subjects. In men with tPSA 3.5-10 ng/mL, the detection rate of PCa was 39.4% (61/155). In this group, PHI and %p2PSA were the most accurate predictors of PCa and significantly outperformed tPSA and %fPSA; area under the curve for tPSA, %fPSA, %p2PSA, and PHI was 0.56, 0.69, 0.74, and 0.76, respectively. PHI was also the strongest predictor of PCa with Gleason score ≥ 7.

Conclusion: This study demonstrates the superior clinical performance of %p2PSA and PHI in predicting the presence and aggressiveness of PCa in Korean men. The %p2PSA and PHI appear to improve detection of PCa and provide prognostic information.

Keywords: Biomarkers; Biopsy; Early Diagnosis; Prostate-specific Antigen; Prostatic Cancer.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Area Under Curve
  • Biomarkers / blood
  • Early Detection of Cancer
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Prospective Studies
  • Prostate-Specific Antigen / blood*
  • Prostatic Neoplasms / diagnosis*
  • Prostatic Neoplasms / pathology
  • Protein Precursors / blood
  • ROC Curve
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Severity of Illness Index

Substances

  • Biomarkers
  • Protein Precursors
  • Reagent Kits, Diagnostic
  • Prostate-Specific Antigen