The time-resolved fluorescence-based PCA3 test on urinary sediments after digital rectal examination; a Dutch multicenter validation of the diagnostic performance.
OBJECTIVE
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.


METHODS
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.
van Gils
Martijn P M Q
MP
Department of Urology, Radboud University Nijmegen Medical Centre, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands.
Hessels
Daphne
D
van Hooij
Onno
O
Jannink
Sander A
SA
Peelen
W Pim
WP
Hanssen
Suzanne L J
SL
Witjes
J Alfred
JA
Cornel
Erik B
EB
Karthaus
Herbert F M
HF
Smits
Geert A H J
GA
Dijkman
Gerhard A
GA
Mulders
Peter F A
PF
Schalken
Jack A
JA
D000368:Aged; D000951:Antigens, Neoplasm / Q000096:biosynthesis*; D001706:Biopsy; D051517:Digital Rectal Examination; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009426:Netherlands; D011237:Predictive Value of Tests; D017430:Prostate-Specific Antigen / Q000652:urine; D011471:Prostatic Neoplasms / Q000175:diagnosis*; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013050:Spectrometry, Fluorescence / Q000379:methods*
D000951:Antigens, Neoplasm; C479341:prostate cancer antigen 3, human; D017430:Prostate-Specific Antigen