Purpose: To improve the specificity in prostate cancer diagnosis and to prevent unnecessary prostate biopsies, especially in the serum prostate-specific antigen (PSA) ''gray zone'' between 3 and 15 ng/mL, the implementation of prostate cancer^specific markers is urgently needed. The recently discovered prostate cancer antigen 3 (PCA3) is such a promising prostate cancer marker. In a previous single institution study, the PCA3 urine test clearly proved to be of diagnostic value.Therefore, the diagnostic performance of the PCA3 urine test was validated in a multicenter study. Experimental Design:The first voided urine after digital rectal examination was collected from a total of 583 men with serum PSA levels between 3 and 15 ng/mL who were to undergo prostate biopsies. We determined the PCA3 score in these samples and correlated the results with the results of the prostate biopsies. Results: A total of 534 men (92%) had an informative sample. The area under the receiveroperating characteristic curve, a measure of the diagnostic accuracy of a test, was 0.66 for the PCA3 urine test and 0.57 for serum PSA. The sensitivity for the PCA3 urine test was 65%, the specificity was 66% (versus 47% for serum PSA), and the negative predictive value was 80%. Conclusions: In this multicenter study, we validated the diagnostic performance of the PCA3 urine test in the largest group studied thus far using a PCA3 gene-based test. This study shows that the PCA3 urine test, when used as a reflex test, can improve the specificity in prostate cancer diagnosis and could prevent many unnecessary prostate biopsies.

Please be advised that this information was generated on 2018-05-13 and may be subject to change. 0 0 2 2 -5 3 4 7 /9 7 /1 5 8 1~0 1 6 0 $ 0 3 .0 0 /0 T he J ournal o f U rology C o p y rig h t © 1997 b y A m erican U rological A^v^rv n o N , I nc. V ol. 1 5 8 , 1 6 0 -1 6 3 , J u l y l í P rin ted in U.& M aterials a n d M ethods; A large double-blind tria l w as done on 457 p atien ts random ized to receive n ilu ta m id e or placebo after orchiectomy. LONG-TERM EFFICACY AND SAFETY OF NILUTAMIDE PLUS CASTRATION IN ADVANCED PROSTATE CANCER, AND THE SIGNIFICANCE OF EARLY PROSTATE SPECIFIC ANTIGEN NORMALIZATIONGERHARDR esults: A t 8.5 y e a rs of followup significant benefits were found for progression and su rv iv al in favor of p a tie n ts receiving n ilu tam id e an d orchiectomy. In addition, norm alized p ro state specific an tig en levels a t 3 m o n th s from th e s ta r t of th e ra p y w ere predictive of good long-term outcome. M oreover, com bined an d ro g en blockade w ith nilutam ide increased th e chance of p a tie n ts h av in g n o rm al p ro sta te specific an tig en levels a t 3 m onths. N ilutam ide w as well to lerated in th e long te rm w ith no in cre ase in th e incidence of drug specific adverse events.Conclusions: W ith lo ng-term followup of p a tie n ts w ith advanced p ro state cancer, th e combi n a tio n of n ilu ta m id e a n d orchiectom y h as significant benefits in in terv al to progression an d im proved su rv iv al com pared to orchiectom y and placebo.K ey W o rd s: p ro sta tic neoplasms, orchiec

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