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Imaging, Diagnosis, Prognosis |
Authors' Affiliations: 1 Department of Urology, Radboud University Nijmegen Medical Centre, 2 Department of Urology, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands, 3 Department of Urology, Twente Hospital Group (Location SMT), Hengelo, the Netherlands, 4 Department of Urology, Alysis Healthcare Group (Rijnstate Hospital), Arnhem, the Netherlands, and 5 Department of Urology, Amphia Hospital (Location Molengracht), Breda, the Netherlands
Requests for reprints: Jack A. Schalken, Department of Urology (Internal Postal Code 267), Radboud University Nijmegen Medical Centre, P.O. Box 9101, 6500 HB Nijmegen, the Netherlands. Phone: 31-24-3617662; Fax: 31-24-3541222; E-mail: J.Schalken{at}uro.umcn.nl.
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 receiver-operating 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.
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