Abstract
PURPOSE: To externally validate a novel prostate cancer (PCa) risk-calculator (RC), based on data of the Swiss arm of the European Randomize Study of Screening for Prostate Cancer (ERSPC), and to assess whether the RC (ProstateCheck) is superior to the PCPT RC and SWOP RC in an independent Swiss cohort.
MATERIALS AND METHODS: Data of all men who underwent prostate biopsy in an academic tertiary care center between 2004 and 2012 were retrospectively analyzed. The probability of having any PCa or high-grade PCa (Gleason score ≥7) upon prostate biopsy was calculated using the ProstateCheck-RC. The RC's performance was assessed using calibration and discrimination and additionally compared with the PCPT- and SWOP-RC by decision curve analyses.
RESULTS: Of 1615 men, 401 (25%) were diagnosed with any PCa and 196 (12%) with high-grade PCa. Our analyses of the ProstateCheck-RC revealed good calibration in the low risk range (0 to 0.4) and moderate overestimation in the higher risk range (0.4 to 1) for any and high-grade PCa. The AUC for the discrimination of any PCa and high-grade PCa was 0.69 and 0.72, respectively, which was slightly but significantly higher compared to the PCPT-RC (0.66 and 0.69, respectively) and SWOP-RC (0.64 and 0.70, respectively). Decision analysis taking into account the harms of transrectal ultrasound measurements of prostate volume, found little benefit for ProstateCheck-RC, with inferior properties to the PCPT- and SWOP-RC.
CONCLUSION: Our independent external evaluation revealed moderate performance of the ProstateCheck-RC. Its clinical benefit is limited and inferior to the PCPT- and SWOP-RC.