Prognostic Test Predicts Prostate Cancer-Specific Death and Metastases

Clinically localized prostate cancer is a unique challenge to physicians and patients, because it is a highly variable and often slow growing, nonaggressive cancer. A prognostic test, in conjunction with clinical parameters such as Gleason score and prostate specific antigen (PSA), predicts prostate cancer aggressiveness.

Called Prolaris, the test developed by Myriad Genetics, (Salt Lake City, UT, USA) measures the expression level of genes involved with tumor proliferation to predict disease outcome. It is a novel 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 31 genes related to the progression of tumor cell division. Low gene expression is associated with a low risk of disease progression in men who may be candidates for surveillance, whereas high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. Prolaris has been proven to predict prostate cancer-specific disease progression in 11 clinical trials with more than 5,000 patients.

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% of cases, physicians changed their intended therapy and selected a different treatment based on the Prolaris test score. In 40% of patients, physicians reduced the therapeutic burden on patients and opted for conservative management options such as active surveillance and watchful waiting. In 25% of cases, physicians increased treatments including the use of surgery or radiation, and in 35% of cases, physicians did not change their treatment plans.

Myriad Genetics, Inc. presented results from PROCEDE 500, a clinical utility study with its Prolaris test, at the 2014 ASCO Genitourinary Cancers Symposium in San Francisco (CA, USA). The study demonstrated the significant clinical value of Prolaris to physicians who are treating men with prostate cancer. The Prolaris test was validated in 11 clinical studies with more than 5,000 patients.

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% of cases, physicians changed their intended therapy and selected a different treatment based on the Prolaris test score. In 40% of patients, physicians reduced the therapeutic burden on patients and opted for conservative management options such as active surveillance and watchful waiting. In 25% of cases, physicians increased treatments including the use of surgery or radiation, and in 35% of cases, physicians did not change their treatment plans.

Ashok Kar, MD, St. Joseph's Hospital (Orange, CA, USA) said: "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. 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."

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