Abstract

Evaluating the performance of serum prostate-specific antigen (PSA) test in population-based screening with receiver operating characteristics (ROC) curve often neglects the time dimension. Asymptomatic cases with negative PSA test would have been missed if sojourn time is not taken into account to allow for cases surfacing into the clinical phase. Data included 20,796 men with PSA test at the first screening round was used from population-based Finnish prostate cancer screening trial during 1996–1999. Cancers detected at the first screen, together with interval cancers ascertained during 4-year follow-up were expediently used to estimate sensitivity and specificity. A sojourn-time-corrected model was applied to estimating the possible false negative cases for those with PSA < 4 ng/ml for correcting the ROC curve. The estimated sensitivity estimate was reduced from 94.4% without correction to 68.8% with correction but the estimated specificity was identical (89.4% vs. 89.2%) at cutoff of 3 ng/ml. The corrected area under curve (AUC) [77.0% (74.9–79.1%)] of the PSA test was significantly lower than the uncorrected AUC [95.9% (95.3–96.6%)]. The failure of considering the time since last negative screen due to incomplete ascertainment for asymptomatic cancer led to the overestimation of PSA test performance that further affects the cut-off value of PSA tests for population-based prostate cancer screening.

Highlights

  • Incomplete ascertainment of prostate cancer (PrCa) using the prostate-specific antigen (PSA) test for clinical patients was ­noted[1]

  • Of the 713 PrCa cases, 40 interval cancers occurred in the 17,890 men with PSA < 3 ng/ml, with an incidence rate of 2.2 per 1000 man-years, which is dramatically lower than 240.6 per 1000 based on the finding of 584 screen-detected and 89 interval cancers in 2797 men with PSA ≥ 3 ng/ml

  • The very higher area under curve (AUC) would mislead us about the good performance of PSA test

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Summary

Introduction

Incomplete ascertainment of prostate cancer (PrCa) using the prostate-specific antigen (PSA) test for clinical patients was ­noted[1]. The sensitivity of the PSA test at the selected threshold may be ­overestimated[1] if fewer men with negative results undergo confirmatory diagnosis with biopsy because false negative cases may be incompletely ascertained. This incomplete ascertainment renders the receiver operating characteristic (ROC) curve inaccurate for evaluations of sensitivity, specificity, and area under curve (AUC). To correct this ascertainment bias, two studies performed biopsies for the entire range of PSA results to ascertain PrCa below the cutoff of the PSA ­test[2,3]. This approach is not theoretically sound because the follow-up time for allowing

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