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New Study

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The PCA3 Assay improves the prediction of initial biopsy outcome and may be indicative of prostate cancer aggressiveness

De la Taille A, Irani J, Graefen M, de Reijke T, Kil P, Gontero P, Chun F, Mottaz A, Haese A. Eur Urol Suppl 2010;9:53 (abstract n.61). Presented at the 25th annual meeting of the European Association of Urology (EAU), 16-20 April 2010, Barcelona, Spain

• This prospective, multi-national European study shows that the PCA3 Score improves the prediction of initial biopsy outcome and may be indicative of prostate cancer (PCa) aggressiveness. The PCA3 Assay can aid in the decision which men with a suspicion of PCa need an initial biopsy when managed in clinical practice in Europe

• In 516 men with a serum total prostate specific antigen (PSA) level 2.5-10 ng/mL scheduled for initial biopsy, an increasing PCA3 Score corresponded with an increasing probability of a positive initial biopsy (Figure 1)

• The diagnostic accuracy of the PCA3 Score for predicting initial biopsy outcome was statistically significantly better than that of serum total PSA, PSA density (PSAD) and % free PSA (Figure 2)

• The clinical utility of the PCA3 Assay was independent of age and serum total PSA level

• The PCA3 Score was statistically significantly higher in men with Gleason score ≥ 7 vs. <7, > 33% positive cores vs. ≤ 33% positive cores, and significant vs. indolent cancer (according to Epstein criteria). The PCA3 Score may therefore be indicative for aggressiveness of prostate cancer and may aid in the selection of men to be managed with active surveillance

• When using a PCA3 Score cut-off of 35, 60% of biopsies could be prevented while 11% PCa with a Gleason score ≥ 7 would be missed. Likewise, at a PCA3 Score cut-off of 20, 40% of biopsies could be prevented while 2% of PCa with a Gleason score ≥ 7 would be missed

• It was concluded that the PCA3 Assay is a simple urine test that can be of additional help for urologists in counselling patients whether or not to perform an initial biopsy

Figure 1: The higher the PCA3 Score, the greater the probability of a positive biopsy

Figure 2: The diagnostic accuracy of the PCA3 Assay, serum total PSA, PSAD and % free PSA

Reviewed by:

Prof. J. Schalken and Prof. H. van Poppel

Editorial comment:

This is the first report on a prospective multicenter study on the utility in a cohort of biopsy naïve patients (PSA 2.5-10 ng/mL). The authors show that PCA3 predicts biopsy outcome and the test has a higher sensitivity for the high grade cancers. The clinical implications are significant, i.e. one can prevent up to 60 % of biopsies, while missing 11 % of tumors with Gleason score of 7 or higher. These data now prompt the question how the test performs in the low PSA ranges.
The study suggests that the test which is now indicated for the decision to take repeat biopsies, may even be used to guide the decision for a first biopsy in men with PSA between 2.5 and 10 ng/mL.

More information:

https://www.europeanurology-supplement.com/issues/contents?issue_key=S1569-9056(10)X0003-3 or view or dowload poster https://www.pca3.org/pro/educational-material/Poster_EAU2010_PCA3_FirstBxStudy.swf/view