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Prolaris test in prostate cancer care

Clinical data for the Prolaris test show a 'significant ability' to help physicians improve care for men diagnosed with prostate cancer.

Myriad Genetics Inc has presented clinical data for its Prolaris test at the 2015 AUA meeting and the results highlighted and underscored the significant ability of the Prolaris test to help physicians improve care for men diagnosed with prostate cancer.

In this pioneering study, Myriad presented important new clinical validation data that establishes an active surveillance (AS) threshold for men with localised prostate cancer. Specifically, the AS threshold is a composite of the Prolaris test score and clinico-pathologic features. In the validation data featured at AUA, the pre-defined AS threshold was evaluated in 765 conservatively managed men, and the clinical endpoint was 10-year risk of prostate cancer mortality. The results showed that at the AS threshold, the predicted 10-year survival rate of prostate cancer patients was 97%. Conversely, there was a 3% risk of 10-year, prostate-specific mortality. Importantly, however, there were no observed prostate cancer-specific deaths over 10 years among men whose scores fell below the AS threshold.

Additionally, a separate analysis of 4,218 patients was performed to determine what percentage of patients who were clinically tested with Prolaris would be candidates for active surveillance based on the validated AS threshold. Of this commercial cohort, 36% qualified for active surveillance based on their clinical features alone. However, when the Prolaris test was added to the clinical risk assessment, 60% of these patients fell below the AS threshold, representing a significant increase in the total number of candidates who may be eligible for active surveillance.

"Active surveillance is an important treatment option for men with prostate cancer. The Prolaris active surveillance threshold represents a significant change in the treatment of prostate cancer because it provides valuable mortality prognostic information at the time of diagnosis," said Dr Michael Brawer, vice president of medical affairs, Myriad Genetic Laboratories. "Men whose combined Prolaris Scores and clinico-pathologic features fall below the AS threshold can have confidence that active surveillance is an appropriate option for them instead of surgery, radiation or chemotherapy."

In a podium presentation, Dr Neal Shore, medical director at Carolina Urologic Research Centre, presented the final results from PROCEDE 1000, the largest prospective clinical utility study to measure the impact of the Prolaris test on the treatment of men with localised prostate cancer.

The analysis of 1,206 patients demonstrated that physicians changed their treatment plans in 48% of cases after receiving the Prolaris test results. Of these changes, 72.1% were reductions in treatment, and 26.9% were increases in treatment.

"We are very impressed by these real-world data. Prolaris does what it is designed to do: help physicians determine the aggressiveness of prostate cancer and thus personalise treatment plans for their patients based upon that information," said Shore. "Men with a high Prolaris Score, who are at high risk of disease-specific mortality or recurrence, are receiving more aggressive treatment, which should help save more lives. Meanwhile, more patients with a low Prolaris Score are receiving active surveillance, which spares them from the side effects frequently associated with more aggressive treatments."

[link url="https://www.myriad.com/investors/press-release-detail/?newsItemId=913393"]Myriad material[/link]
[link url="http://www.aua2015.org/abstracts/searchabstracts.cfm"]AUA 2015 abstract[/link]

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