Myriad Genetics, Inc. has announced that results from the EMPATHY-P clinical study of Prolaris in patients newly diagnosed with prostate cancer will be highlighted at the 30th Annual Congress of the European Association of Urology.
"EMPATHY-P showed that Prolaris provides valuable clinical information that can help physicians improve healthcare and outcomes for their patients with early prostate cancer," said Colin Hayward, M.D., European medical director, Myriad. "There is no one-size-fits-all treatment approach in prostate cancer. Prolaris provides objective genetic information to help clinicians tailor treatment plans based on patients' individual risk profiles."
The EMPATHY-P study evaluated the Prolaris test on 525 patient biopsy samples to determine the aggressiveness of prostate cancer in these newly diagnosed patients from five European countries including: Italy, Germany, Spain, Switzerland and the UK. 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 EMPATHY-P data showed, overall, that the Prolaris test found 42 percent of the European men evaluated had a risk profile that was either lower or higher than would be expected using clinical pathology. Interestingly, this finding is consistent with the previously published U.S. Prostate Biopsy Research study, which found 51 percent of U.S. patients had a risk profile that differed from clinical pathology. Specifically, EMPATHY-P demonstrated that the Prolaris test score found 22 percent of the European patients had less aggressive prostate cancer and 20 percent had more aggressive prostate cancer compared to standard clinical pathology measurements.
"Prolaris has been shown in multiple clinical studies to be more effective than clinical pathology at determining the aggressiveness of prostate cancer and providing patients with an accurate risk profile based on their own genetic signature," said Hayward. "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."
About Prolaris®
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. For more information visit: www.prolaris.com.
Poster #321 - European multi-centre study to assess the aggressiveness of prostate carcinoma in newly diagnosed patients using a cell-cycle gene expression assay. (Prolaris) in biopsy specimens (EMPATHY-P Study).