Prostate Ca assays show economic, clinical benefits

The Prolaris prostate cancer test could save the health care system $6 billion over 10 years, according to data from one of several new studies examining the economic and clinical benefits of newer biomarker-based prostate cancer assays.

The Prolaris prostate cancer test could save the health care system $6 billion over 10 years, according to data from one of several new studies examining the economic and clinical benefits of newer biomarker-based prostate cancer assays.

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Additional studies showed that physicians are using the Prolaris test (Myriad Genetics) appropriately to personalize patients' treatment options and that the Oncotype DX prostate cancer test (Genomic Health) has value in enabling physicians and patients to avoid over- and under-treatment of the disease. All of the studies were presented at the Society of Urologic Oncology annual meeting in Rockville, MD.

In a study evaluating the economic impact of the Prolaris test, researchers led by E. David Crawford, MD, of the University of Colorado, Denver, found the test reduced costs by $2,850 per patient tested. Over a 10-year period, this could save the health care system $6 billion, according to a press release from Myriad Genetics. For a health plan of approximately 30 million members, this would translate into more than $48 million in savings, the company said.

Two studies examined clinical benefits of the Prolaris test:

  • Interim results were presented from PROCEDE 1000, which evaluated the impact of the Prolaris test on personalizing prostate cancer treatment. The interim data analysis of 816 patients demonstrated that physicians changed their treatment decisions in 44% of cases based on Prolaris results, reported Mark Gonzalgo, MD, PhD, of the University of Miami.

  • A clinical study validated an active surveillance threshold for Prolaris in 585 conservatively managed men with localized prostate cancer. The clinical endpoint was prostate cancer mortality. Results showed that there were no observed cancer deaths in patients who fell below the defined threshold, reported Steven Stone, PhD, of Myriad Genetics. In a separate analysis of 1,718 patients from a commercial cohort, approximately 55% of the patients qualified for active surveillance based on the threshold.

"The validation of an active surveillance threshold will help us identify many more men who are good candidates for surveillance than appear to be based on their clinical features alone. For men considering deferred treatment, falling below the threshold will give them confidence that active surveillance is a realistic option instead of a more aggressive treatment," said Michael Brawer, MD, of Myriad Genetics.


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The SUO meeting also featured presentations of studies evaluating the OncoType DX prostate cancer test. First, results from a clinical validation study that was also published online in European Urology (Nov. 30, 2014) showed that the Oncotype DX test predicts near- and longer-term outcomes in a racially diverse group of men with clinically localized prostate cancer, Genomic Health said in a press release.

Among the findings reported by the Uniformed Services University of the Health Sciences' Center for Prostate Disease Research:

  • The biopsy-based Oncotype DX genomic prostate score (GPS) was a robust and independent measure of multiple clinically relevant endpoints, including adverse surgical pathology (p<.001) and long-term risk of biochemical recurrence after surgery (p<.001).

  • The Oncotype DX GPS was very similarly predictive of outcomes in Caucasian and African-American men regardless of their race.

  • The established multiple prostate cancer-specific pathways contributed to the robust predictive value of the Oncotype DX GPS.

Separately, results of a decision impact study showed that use of the Oncotype DX test significantly changed treatment recommendations. The prospective study in a contemporary population of men with low- or intermediate-risk disease showed that the use of the test substantially increased the number of men who would be eligible for active surveillance. Additionally, use of the test increased physician confidence in their treatment recommendations.

"Prostate cancer comes in many different forms and having confidence in your treatment recommendation and decision is crucial. Nearly half of prostate cancer is not aggressive, and now we have more advanced tools like genomic profiling with the Oncotype DX test to determine a man's individual risk,” said lead investigator Ketan K. Badani, MD, of Mount Sinai Health System, New York.

Genomic Health said the complete results of this study have been accepted for publication in Urology Practice.

Dr. Crawford is an adviser to and a speaker for Genomic Health, MDxHealth, and Myriad Genetics. Dr. Badani has served as a consultant/adviser to Genomic Health and Genome Dx.

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