We estimated the sensitivity of serum prostate-specific antigen (PSA) as a screening test for prostate cancer in the Finnish randomised, population-based prostate cancer screening trial. The study population consisted of 80,458 men aged 55-67 years identified from the national population registry and randomised to the screening or control arm of the trial. The screening algorithm was based on determination of serum PSA concentration. Test sensitivity was estimated based on interval cancer incidence during the first 4 years of follow-up among screening participants with a negative screening test. Interval cancers were defined as those occurring among men with a negative screening test. Altogether, 19 interval cancers were detected among 17,897 men with serum PSA < 3 ng/ml during the first screening interval. A further 5 cases were diagnosed among 811 men with PSA 3.0 -3.9 ng/ml with a benign digital rectal examination or free total PSA ratio > 0.16. Test sensitivity based on serum PSA of 3 ng/ml was estimated to be 0.89 (95% confidence interval 0.84 -0.93) and that based on PSA of 4 ng/ml combined with an ancillary test (digital rectal examination or free total PSA ratio in the PSA range 3.0 -3.9) was 0. Prostate cancer is the most common cancer among men in most industrialised countries. 1 Large randomised studies have been launched to assess the effectiveness of prostate cancer screening with serum prostate-specific antigen (PSA). 2,3 Despite the widespread use of PSA for prostate cancer screening, its sensitivity has not been evaluated properly, i.e., using a longitudinal approach in the context of a randomised trial. The sensitivity of a screening program provides a key measure of screening performance; i.e., it is an essential intermediate indicator in the absence of mortality results.Sensitivity is the ability to detect disease cases, determined by the frequency of false-negative test results. In the screening setting, cross-sectional evaluation of sensitivity (as used for evaluation of diagnostic tests) based on results obtained by simultaneously performed tests is not sufficient because screening is intended to detect cases that would clinically surface in the future (above all, cases that would do so before the next screening round). Furthermore, diagnostic assessment is generally limited to subjects with a positive screening test, and it is prone to overdiagnosis, i.e., detection of cancers that would not have surfaced clinically in the absence of screening. This approach yields inflated estimates of sensitivity. 4,5 This is particularly evident for prostate cancer, which has a high prevalence of indolent cancers at autopsy. A more valid approach for evaluation of the sensitivity of screening is the incidence method, which is based on the reduction in disease incidence following screening (i.e., a longitudinal approach). Ideally, sensitivity is estimated by comparison between screening and control groups formed by randomisation, i.e., in an experimental setting. With this approach, test sensitivity (sen...