News Release

Prostate cancer gene test provides new early detection

European Urology Study reveals simple urine test may reduce unnecessary and expensive biopsies

Peer-Reviewed Publication

Elsevier

Arnhem, 16 October 2008 – Prostate cancer (PCa) is one of the most common male cancers in the Western world. Currently, early detection of PCa depends on an abnormal digital rectal examination and an elevated prostate-specific-antigen (PSA) level requiring a prostate biopsy, often associated with anxiety, discomfort, complications, and heavy expenses. The prostate-cancer-gene-3 (PCA3) test is a new PCa gene-based marker carried out with a urine sample. PCA3 is highly specific to PCa and has shown promising early detection results at repeat biopsy. It may allow patients to avoid unnecessary biopsies. The PCA3 gene is dominant in over 95% of malignant prostate tissue compared to benign and normal prostate tissue.

Several studies have been done to evaluate the PCA3 assay. In 2007, Marks et al showed that urine PCA3 levels were more accurate than serum PSA measurements for predicting the results of repeat biopsy (Marks LS, Fradet Y, Deras IL, et al. PCA3 molecular urine assay for prostate cancer in men undergoing repeat biopsy. Urology 2007; 69:532��).

In the October 2008 issue of European Urology (http://www.elsevier.com/locate/eururo), Haese et al took the study by Marks et al even further in their evaluation of the PCA3 assay in a larger population of European men with one or two negative biopsies scheduled for repeat biopsy in order to determine its effectiveness in detecting PCa at repeat biopsy.

The PCA3 score was calculated and compared to biopsy outcome. The diagnostic accuracy of the PCA3 assay was compared to the percentage of free prostate-specific antigen (%fPSA). Most of the PSA that circulates in the serum is attached to larger protein substances, so called 'complexed' PSA. The rest of the PSA is unbound or 'free'. Research suggests that PSA created by prostate cancer is more likely to be the 'complexed' type while non-cancerous or benign PSA is more the 'free' type.

In 463 men, the positive repeat biopsy rate was 28%. The probability of a positive repeat biopsy increases with rising PCA3 scores. The PCA3 score was superior to %fPSA for predicting repeat prostate biopsy outcome and may be indicative of clinical stage and significance of PCa.

The utility of the PCA3 score is independent of the number of previous biopsies, prostate volume, and total PSA.

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An editorial by Stacy Loeb in the same issue discusses whether PCA3 helps in determining clinically relevant PCa.

About the European Association of Urology (EAU)

The European Association of Urology (EAU) represents more than 16,000 urology professionals across Europe and worldwide. Its mission is to raise the level of urological care in Europe. The EAU has special sections on the Internet, such as Uroweb (www.uroweb.org) and Urosource (www.urosource.com), which allows for direct communication. European Urology, produced by the EAU, has been a respected urological forum for over 20 years, and is currently read by more than 9,000 urologists across the globe. With an impact factor of 5.634, the journal has become the leading scientific publication in the field of urology.

About Elsevier

Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health communities, Elsevier's 7,000 employees in over 70 offices worldwide publish more than 2,000 journals and 1,900 new books per year, in addition to offering a suite of innovative electronic products, such as ScienceDirect (http://www.sciencedirect.com/), MD Consult (http://www.mdconsult.com/), Scopus (http://www.info.scopus.com/), bibliographic databases, and online reference works.

Elsevier (http://www.elsevier.com/) is a global business headquartered in Amsterdam, The Netherlands and has offices worldwide. Elsevier is part of Reed Elsevier Group plc (http://www.reedelsevier.com/), a world-leading publisher and information provider. Operating in the science and medical, legal, education and business-to-business sectors, Reed Elsevier provides high-quality and flexible information solutions to users, with increasing emphasis on the Internet as a means of delivery. Reed Elsevier's ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).


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