At the 2014 ASCO Genitourinary Cancers Symposium in San Francisco, Calif, Myriad Genetics, Inc. (NASDAQ: MYGN) announced results from PROCEDE 500, a clinical utility study with its Prolaris test.
The study demonstrated the significant clinical value of Prolaris to physicians who are treating men with prostate cancer. Prolaris is a prognostic test that accurately predicts prostate cancer-specific death and metastases and has been validated in 11 clinical studies with more than 5,000 patients.
"Prolaris has opened the door to a new era of personalized cancer treatment for men with prostate cancer," said Michael Brawer, M.D. vice president of medical affairs at Myriad Genetic Laboratories. "The Prolaris score is a stronger predictor of prostate cancer death and recurrence than either Gleason score or PSA (prostate specific antigen), and delivers clinically relevant information not provided by any other prognostic test."
PROCEDE 500 is an ongoing prospective registry study designed to examine the clinical utility of Prolaris. Currently, 331 patients have been enrolled and 150 clinicians have completed surveys in 305 cases to assess the influence of the Prolaris score on clinical decision making. Results for these interim data show that in 65 percent of cases, physicians changed their intended therapy and selected a different treatment based on the Prolaris test score. "
In 40 percent of patients, physicians reduced the therapeutic burden on patients and opted for conservative management options such as active surveillance and watchful waiting. In 25 percent of cases, physicians increased treatments including the use of surgery or radiation, and in 35 percent of cases, physicians did not change their treatment plans. Full results from PROCEDE 500 have been submitted to a peer-reviewed medical journal for publication.
"As a clinical researcher, I advocate for evidence-based medicine. The Prolaris test score accurately tells me if a patient has an aggressive prostate cancer or not and guides my treatment decisions," said Ashok Kar, M.D., St. Joseph's Hospital in Orange, Calif. "As a practicing physician, I must ask the same question for every patient; should I use surgery or radiation, or should I use active surveillance and watchful waiting? Prolaris helps me answer this critical clinical question."