Multicenter evaluation of [-2]proprostate-specific antigen and the prostate health index for detecting prostate cancer

Total prostate-specific antigen (tPSA) is flawed for prostate cancer (PCa) detection. [-2]proprostate-specific antigen (p2PSA), a molecular isoform of free PSA (fPSA), shows higher specificity compared with tPSA or percentage of free PSA (%fPSA). The prostate health index (Phi), a measure based on p...

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Published in:Clinical chemistry (Baltimore, Md.) Md.), 2013-01, Vol.59 (1), p.306-314
Main Authors: Stephan, Carsten, Vincendeau, Sébastien, Houlgatte, Alain, Cammann, Henning, Jung, Klaus, Semjonow, Axel
Format: Article
Language:English
Subjects:
Biomarkers
Biopsy
Calibration
Case-Control Studies
Clinical medicine
Humans
Male
Prostate cancer
Prostate-Specific Antigen - blood
Prostatic Neoplasms - diagnosis
Prostatic Neoplasms - pathology
ROC Curve
Sensitivity and Specificity
Studies
Tumors
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Summary:Total prostate-specific antigen (tPSA) is flawed for prostate cancer (PCa) detection. [-2]proprostate-specific antigen (p2PSA), a molecular isoform of free PSA (fPSA), shows higher specificity compared with tPSA or percentage of free PSA (%fPSA). The prostate health index (Phi), a measure based on p2PSA and calculated as p2PSA/fPSA × √tPSA, was evaluated in a multicenter study for detecting PCa. A total of 1362 patients from 4 different study sites who had tPSA values of 1.6-8.0 μg/L (668 patients with PCa, 694 without PCa) underwent ≥10 core biopsies. Serum concentrations of tPSA, fPSA (both calibrated against a WHO reference material), and p2PSA were measured on Access2 or DxI800 analyzers (Beckman Coulter). The percentage ratio of p2PSA to fPSA (%p2PSA) and Phi were significantly higher in all PCa subcohorts (positive initial or repeat biopsy result or negative digital rectal examination) (P < 0.0001) compared with patients without PCa. Phi had the largest area under the ROC curve (AUC) (AUC = 0.74) and provided significantly better clinical performance for predicting PCa compared with %p2PSA (AUC = 0.72, P = 0.018), p2PSA (AUC = 0.63, P < 0.0001), %fPSA (AUC = 0.61) or tPSA (AUC = 0.56). Significantly higher median values of Phi were observed for patients with a Gleason score ≥7 (Phi = 60) compared with a Gleason score
ISSN:0009-9147
1530-8561
DOI:10.1373/clinchem.2012.195784