Validation Study Shows Prolaris Test Identifies Men Who May Benefit from Surgery or Radiation at the Time of a Prostate Cancer Diagnosis

San Francisco, CA ( — Myriad Genetics, Inc., a global leader in personalized medicine, announced the publication of results from a large study that demonstrated the Prolaris test can accurately predict the 10-year risk of metastases in men newly diagnosed with localized prostate cancer.  The study was published in journal Prostate Cancer and Prostatic Diseases

“This study demonstrates that the Prolaris test effectively identified those men with localized prostate cancer who progressed to metastatic disease,” said Stephen Bardot, M.D., a study investigator and chairman, Department of Urology Associate Medical Director, Surgical Services at the Oschner Clinic.  “Importantly, the Prolaris test provided critical information that can be used to determine which men with localized prostate cancer are candidates for active surveillance and which men should receive definitive therapy with surgery or radiation at the time of diagnosis.”  

The large pooled analysis included 1,062 men with localized prostate cancer who were definitively treated with surgery (n=800) or radiation (n=262).  The primary objective was to evaluate ability of the Prolaris test (CCP score) and the Prolaris test combined with clinical information (CCR) to predict 10-year risk of progression to metastatic disease.  The analysis demonstrated the Prolaris test was the strongest independent predictor of progression to metastatic disease, and men were approximately three times more likely to develop metastatic disease with each unit increase in the Prolaris test score (HR: 2.93; p=1.8×10-11).  When the Prolaris test score was combined with clinical information the results were even more highly prognostic, and men were up to four times more likely to develop metastases with each unit increase in the test score (Figure 1: HR: 4.00; p=6.3×10-21).

Figure 1.  Prolaris Test Accurately Predicts Risk of Prostate Cancer ProgressionMyriad062719

“We are excited by these positive study results that advance our understanding of prostate cancer and build on multiple prior studies demonstrating the clinical performance of the Prolaris test,” said Todd Cohen, M.D., board certified urologist and vice president of Medical Affairs, Myriad Urology.  “Importantly, these data showed that men with localized prostate cancer and a high Prolaris score were up to four times more likely to develop metastatic disease. This information can help guide treatment planning decisions so that men receive the best care and health outcomes.”