The Time-Resolved Fluorescence-Based PCA3 Test on Urinary Sediments after Digital Rectal Examination; a Dutch Multicenter Validation of the Diagnostic Performance

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 discovere...

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Bibliographic Details
Published in:Clinical cancer research 2007-02, Vol.13 (3), p.939-943
Main Authors: van Gils, Martijn P M Q, Hessels, Daphne, van Hooij, Onno, Jannink, Sander A, Peelen, W Pim, Hanssen, Suzanne L J, Witjes, J Alfred, Cornel, Erik B, Karthaus, Herbert F M, Smits, Geert A H J, Dijkman, Gerhard A, Mulders, Peter F A, Schalken, Jack A
Format: Article
Language:English
Subjects:
Aged
Antigens, Neoplasm - biosynthesis
Biopsy
Diagnosis
Digital Rectal Examination
human
Humans
Male
Middle Aged
Multicenter Studies as Topic
Multicenter Study
Netherlands
Predictive Value of Tests
prostate cancer antigen 3
Prostate-Specific Antigen - urine
Prostatic Neoplasms
Prostatic Neoplasms - diagnosis
ROC Curve
Sensitivity and Specificity
Spectrometry, Fluorescence - methods
Urine
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Summary: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.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.CCR-06-2679