Myriad Publishes Clinical Utility Study for Prolaris
Data from the Procede 500 study of cell-cycle progression testing indicate that 65% of physicians changed their original treatment plans for men with prostate cancer based on results from the test.
Procede 500 is a prospective registry study designed to evaluate the impact of the Prolaris test by Myriad Genetics Inc, Salt Lake City, on physician treatment recommendations for patients with prostate cancer. 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. Results from the study, “Cell Cycle Progression Score and Treatment Decisions in Prostate Cancer: Results from an Ongoing Registry,” were published online ahead of print in the journal Current Medical Research and Opinion.
“Prolaris is an absolute game changer for urologists because it adds meaningful new prognostic information in terms of risk assessment for prostate cancer patients that will improve their care,” said E. David Crawford, MD, head of the section of urologic oncology at the University of Colorado and first author of the study. “In this study, Prolaris led to major changes in therapies with significant reductions or increases in interventional treatments that were based on patients’ unique risk profiles.”
Prolaris testing 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 surveillance; high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy.
In this study of 305 patients, physicians said they would change their treatment plans in 65% of cases after receiving the Prolaris report—122 patients (40%) had a reduction in therapeutic burden, while 76 patients (25%) had an increase in therapeutic burden—independent of treatment strategy (i.e., surgery and/or radiation versus active surveillance and/or watchful waiting).
The study also evaluated the shift in treatment paradigms from interventional to noninterventional and vice versa. Of 164 patients initially planned for interventional treatment, 61 were shifted to alternative treatments after receiving a Prolaris test score—a reduction of 37%. Conversely, of 141 patients initially planned for noninterventional treatment, 33 were shifted to interventional therapy after receiving a Prolaris score—an increase of 23%.
Importantly, in this study there was an overall 50% reduction in surgical interventions and a 30% reduction in radiation treatment. Additionally, 96% of the 24 patients with initial “undecided” treatment regimens selected noninterventional options after receiving the Prolaris score. These results demonstrate that the Prolaris test is associated with high clinical utility among urologists.
“In multiple clinical studies, Prolaris was shown to provide personalized risk of cancer-specific death, metastases, or biochemical failure beyond what is achievable with the Gleason score, clinical stage, and PSA data,” said Michael Brawer, MD, vice president of medical affairs at Myriad Genetic Laboratories. “Procede 500 demonstrates that the Prolaris score significantly enhances treatment plans for men with localized prostate cancer.”
Myriad has submitted the Procede 500 data to the Centers for Medicare & Medicaid Services as part of the clinical dossier supporting Medicare reimbursement for Prolaris testing. Based on its data from 11 studies involving more than 5,000 patients, and six publications in peer-reviewed medical journals, the company expects a CMS coverage determination on Prolaris by the end of June 2014.
“More than 30,000 men will die from prostate cancer this year, so there is an urgent need to improve clinical care for patients,” said Brawer. “Prolaris adds real value to the healthcare system by reducing unnecessary surgeries or exposure to radiation for men at low risk, while increasing medical interventions for men with aggressive prostate cancer, which we believe will save and improve more lives and potentially save the healthcare system more money.”
For further information, visit Myriad Genetics.