European data on PCa assay comparable to U.S. findings

Results presented at the EAU Annual Congress bolster the Prolaris test’s efficacy in determining disease aggressiveness.

New data show that the Prolaris prostate cancer test found more than 50% of men had a risk profile that was either lower or higher than would be expected using clinical pathology, suggesting that the pattern of aggressiveness for European and U.S. prostate cancer patients is consistent, according to a recent study.

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Findings from the EMPATHY-P clinical study of Prolaris (Myriad Genetics, Inc., Salt Lake City) were presented at the European Association of Urology annual congress in Madrid, Spain.

The authors evaluated the Prolaris test on 525 patient biopsy samples to determine the aggressiveness of prostate cancer in newly diagnosed patients in Italy, Germany, Spain, Switzerland, and the United Kingdom. The patients' biopsy samples also were evaluated using standard clinical pathology methods (D'Amico/AUA risk stratification), which were then compared to the Prolaris test results.

The Prolaris test found 52% of the European men evaluated had a risk profile that was either lower or higher than would be expected using clinical pathology, according to a press release from Myriad Genetics. The company said this finding is consistent with the previously published U.S. Prostate Biopsy Research study, which found 51% of U.S. patients had a risk profile that differed from clinical pathology. Specifically, EMPATHY-P demonstrated that the Prolaris test score found 22% of the European patients had less aggressive prostate cancer and 20% had more aggressive prostate cancer compared to standard clinical pathology measurements, compared with 18% and 33% in the U.S. Prostate Biopsy Research study, respectively.

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"Our data showed comparable results for both European and U.S. patients. In both groups, men with a low Prolaris score are good candidates for active surveillance, while patients with a high Prolaris score may need more aggressive care,” said senior author Colin Hayward, MD, of Myriad Genetics, in the release.

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