Accuracy of the prostate health index versus the urinary prostate cancer antigen 3 score to predict overall and significant prostate cancer at initial biopsy

• Published in: The Prostate 2015-01, Vol.75 (1), p.103-111
• Main Authors: Seisen, Thomas, Rouprêt, Morgan, Brault, Didier, Léon, Priscilla, Cancel-Tassin, Géraldine, Compérat, Eva, Renard-Penna, Raphaële, Mozer, Pierre, Guechot, Jérome, Cussenot, Olivier
• Format: Article
• Language: English
• Subjects: Accuracy; Adult; Aged; Aged, 80 and over; Antigens; Antigens, Neoplasm - urine; Area Under Curve; biological markers; Biomarkers - urine; Biopsy; Cohort Studies; Double-Blind Method; early detection of cancer; Humans; Male; Middle Aged; Predictive Value of Tests; Prospective Studies; Prostate - pathology; Prostate cancer; prostate-specific antigen; prostatic neoplasm; Prostatic Neoplasms - diagnosis
• ISSN: 0270-4137; 1097-0045
• DOI: 10.1002/pros.22898

BACKGROUND It remains unclear whether the Prostate Health Index (PHI) or the urinary Prostate‐Cancer Antigen 3 (PCA‐3) score is more accurate at screening for prostate cancer (PCa). The aim of this study was to prospectively compare the accuracy of PHI and PCA‐3 scores to predict overall and significant PCa in men undergoing an initial prostate biopsy. METHODS Double‐blind assessments of PHI and PCA‐3 were conducted by referent physicians in 138 patients who subsequently underwent trans‐rectal ultrasound‐guided prostate biopsy according to a 12‐core scheme. Predictive accuracies of PHI and PCA‐3 were assessed using AUC and compared according to the DeLong method. Diagnostic performances with usual cut‐off values for positivity (i.e., PHI >40 and PCA‐3 >35) were calculated, and odds ratios associated with predicting PCa overall and significant PCa as defined by pathological updated Epstein criteria (i.e., Gleason score ≥7, more than three positive cores, or >50% cancer involvement in any core) were estimated using logistic regression. RESULTS Prevalences of overall and significant PCa were 44.9% and 28.3%, respectively. PCA‐3 (AUC = 0.71) was the most accurate predictor of PCa overall, and significantly outperformed PHI (AUC = 0.65; P = 0.03). However, PHI (AUC = 0.80) remained the most accurate predictor when screening exclusively for significant PCa and significantly outperformed PCA‐3 (AUC = 0.55; P = 0.03). Furthermore, PCA‐3 >35 had the best accuracy, and positive or negative predictive values when screening for PCa overall whereas these diagnostic performances were greater for PHI >40 when exclusively screening for significant PCa. PHI > 40 combined with PCA‐3 > 35 was more specific in both cases. In multivariate analyses, PCA‐3 >35 (OR = 5.68; 95%CI = [2.21–14.59]; P 40 (OR = 9.60; 95%CI = [1.72–91.32]; P = 0.001) was the only independent predictor for detecting significant PCa. CONCLUSIONS Although PCA‐3 score is the best predictor for PCa overall at initial biopsy, our findings strongly indicate that PHI should be used for population‐based screening to avoid over‐diagnosis of indolent tumors that are unlikely to cause death. Prostate 75:103–111, 2015. © 2014 Wiley Periodicals, Inc.