Impact of Prostate Health Index Results for Prediction of Biopsy Grade Reclassification During Active Surveillance

J Urol. 2022 Nov;208(5):1037-1045. doi: 10.1097/JU.0000000000002852. Epub 2022 Jul 5.


Purpose: We assessed whether Prostate Health Index results improve prediction of grade reclassification for men on active surveillance.

Methods and materials: We identified men in Canary Prostate Active Surveillance Study with Grade Group 1 cancer. Outcome was grade reclassification to Grade Group 2+ cancer. We considered decision rules to maximize specificity with sensitivity set at 95%. We derived rules based on clinical data (R1) vs clinical data+Prostate Health Index (R3). We considered an "or"-logic rule combining clinical score and Prostate Health Index (R4), and a "2-step" rule using clinical data followed by risk stratification based on Prostate Health Index (R2). Rules were applied to a validation set, where values of R2-R4 vs R1 for specificity and sensitivity were evaluated.

Results: We included 1,532 biopsies (n = 610 discovery; n = 922 validation) among 1,142 men. Grade reclassification was seen in 27% of biopsies (23% discovery, 29% validation). Among the discovery set, at 95% sensitivity, R2 yielded highest specificity at 27% vs 17% for R1. In the validation set, R3 had best performance vs R1 with Δsensitivity = -4% and Δspecificity = +6%. There was slight improvement for R3 vs R1 for confirmatory biopsy (AUC 0.745 vs R1 0.724, ΔAUC 0.021, 95% CI 0.002-0.041) but not for subsequent biopsies (ΔAUC -0.012, 95% CI -0.031-0.006). R3 did not have better discrimination vs R1 among the biopsy cohort overall (ΔAUC 0.007, 95% CI -0.007-0.020).

Conclusions: Among active surveillance patients, using Prostate Health Index with clinical data modestly improved prediction of grade reclassification on confirmatory biopsy and did not improve prediction on subsequent biopsies.

Keywords: biomarkers; prostatic neoplasms; watchful waiting.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biopsy
  • Humans
  • Male
  • Neoplasm Grading
  • Prostate* / pathology
  • Prostate-Specific Antigen
  • Prostatic Neoplasms* / diagnosis
  • Prostatic Neoplasms* / pathology
  • Watchful Waiting / methods


  • Prostate-Specific Antigen