The PROCEDE 500 study demonstrated that 65% of physicians changed their original treatment plans for men with prostate cancer based on results from the Prolaris test. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in 11 clinical studies in more than 5,000 patients.
“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 in Aurora. “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.”
PROCEDE 500 is a prospective registry study that was designed to evaluate the impact of the Prolaris test on physician treatment recommendations for patients with prostate cancer. In this study of 305 patients, physicians said they would change their treatment plans in 65% of cases after receiving the Prolaris report. These changes resulted in 40% of patients having a reduced therapeutic burden, while 25% had an increased therapeutic burden—independent of treatment strategy (ie, surgery and/or radiation vs active surveillance and/or watchful waiting). The study was reported in Current Medical Research and Opinion (2014; doi:10.1185/03007995.2014.899208).
Importantly, in this study there was an overall 50% reduction in surgical interventions and a 30% reduction in radiation treatment. In addition, 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, located in Salt Lake City, Utah. “PROCEDE 500 demonstrates that the Prolaris score significantly enhances treatment plans for men with localized prostate cancer.”
“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 health care 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 health care system more money.”