PROSTATE-SPECIFIC ANTIGEN CHANGE IN THE EUROPEAN RANDOMIZED STUDY OF SCREENING FOR PROSTATE CANCER, SECTION ROTTERDAM RENE ´ RAAIJMAKERS, MARK F. WILDHAGEN, KAZUTO ITO, ALVARO PA ` EZ, STIJN H. DE VRIES, MONIQUE J. ROOBOL, AND FRITZ H. SCHRO ¨ DER ABSTRACT Objectives. To determine the prostate-specific antigen (PSA) velocity, PSA slope, and PSA doubling time (PSADT) in men with positive biopsies, negative biopsies, and no biopsy indications 4 years after an initial screening; and to use this information to improve the test characteristics in the early detection of prostate cancer and provide normal values for these parameters in screened men with and without evidence of prostate cancer. Methods. Within the European Randomized Study of Screening for Prostate Cancer, section Rotterdam, we identified 9575 men with a second determination of PSA 4 years after the initial screening. These men were divided into three groups: men with positive biopsies, negative biopsies, and no biopsy indications in the second round (PSA less than 3.0 ng/mL). The predictive values of PSA dynamics for detection of prostate cancer were calculated. Results. The mean PSA velocity of men with prostate cancer was 0.62 ng/mL/yr versus 0.46 ng/mL/yr for men with a negative biopsy (P = 0.001). The mean PSADT for men with prostate cancer was 5.1 years and for those with a negative biopsy it was 6.1 years (P = 0.002). The PSADT for men with no indication for biopsy was 25.1 years. However, receiver operating characteristic analyses revealed only a moderate value for these test parameters in predicting biopsy outcome. Conclusions. The mean values of PSA velocity, PSA slope, and PSADT in a rescreened population differed significantly between men with and without prostate cancer. However, in predicting the biopsy outcome, the PSA dynamics were of limited value. UROLOGY 63: 316–320, 2004. © 2004 Elsevier Inc. T he European Randomized Study of Screening for Prostate Cancer (ERSPC) is being con- ducted in eight European countries. The primary endpoint is the evaluation of the effect of prostate cancer screening on disease-specific mortality. In addition, the evaluation and development of the most effective screening strategies is an important goal of this study. The Dutch (Rotterdam) section of the ERSPC has recruited 42,376 participants randomized be- tween a screening and a control arm. The initial screening round has been completed, and the screening results can be compared with those of the second round of screening, which is ongoing. Prostate-specific antigen (PSA) measurement is an adequate test for prostatic disease (prostatitis, benign prostatic hyperplasia, and prostate cancer); however, it lacks specificity to serve as a reliable test for prostate cancer alone. We studied the PSA changes over time, specifically PSA velocity (PSAV), PSA slope, and PSA doubling time (PSADT) in men with positive biopsies, negative biopsies, and no biopsy indications 4 years after the initial screening round. This study was supported by grants EUR-94-869 and EUR-98- 1657 (to Erasmus University Rotterdam) from the Dutch Cancer Society, grants 28-2282 and 2000-2-1016 (to Erasmus Univer- sity Rotterdam) from The Netherlands Organization for Health Research and Development (ZONMw), by the 5th Framework program grant QLRI-2000-01741 (to Erasmus University Rotter- dam) from the European Union, and by Europe Against Cancer. From the Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands; and Department of Urology, Hospi- tal Universitario de Getafe, Madrid, Spain Reprint requests: Rene ´ Raaijmakers, M.D., Department of Urology, Erasmus Medical Center, Room Z 841, P.O. Box 2040, Rotterdam 3000 CA, The Netherlands Submitted: June 9, 2003, accepted (with revisions): September 10, 2003 ADULT UROLOGY © 2004 ELSEVIER INC. 0090-4295/04/$30.00 316 ALL RIGHTS RESERVED doi:10.1016/j.urology.2003.09.028