On July 27, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported new data suggesting the Decipher Prostate Biopsy genomic classifier (GC) may help guide treatment decisions for prostate cancer patients who are candidates for active surveillance (AS) (Press release, Veracyte, JUL 27, 2021, View Source [SID1234585229]). The findings, from a retrospective analysis of data from the MUSIC registry, appear online in the journal Prostate Cancer and Prostatic Diseases (PCAN). They provide the first evidence that Decipher scores predict time to definitive treatment and time to treatment failure among men with early-stage prostate cancer.

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"We believe this real-world study and the resulting findings fill a critical gap in prostate cancer treatment, which is the need for an objective tool that can help physicians identify those early-stage patients who are good candidates for active surveillance as well as those who should move directly to definitive treatment with surgery or radiotherapy," said Elai Davicioni, Ph.D., Veracyte’s senior vice president, Scientific and Clinical Operations, Urologic Cancers.

MUSIC (Michigan Urological Surgery Improvement Collaborative) is a large, prospective, observational, statewide registry created to optimize urologic care across the state of Michigan. Between February 2015 and October 2019, 855 MUSIC registry participants with newly diagnosed prostate cancer underwent testing with the Decipher Prostate Biopsy test.

For the analysis published today, researchers retroactively reviewed the Decipher risk scores from these 855 men to evaluate the independent association of Decipher high scores with the time to conversion from AS to radical therapy (TTT) and the time to treatment failure (TTF; biochemical failure or receipt of salvage therapy).

Of the 241 evaluable patients who elected to undergo active surveillance, a high-risk Decipher score was independently associated with shorter TTT (HR 2.51, 95% CI 1.52-4.13, p<0.001). Men with high-risk scores spent significantly less time on AS than men with Decipher low/intermediate risk scores (13.6 months vs. 33 months; p<0.001). Similarly, among the 479 evaluable patients who underwent definitive treatment either initially or after a period of AS, those with a Decipher high-risk score had a significantly shorter TTF as compared to those with lower scores (p=0.007).

"We have long needed better risk stratification tools for early-stage prostate cancer patients to reduce the uncertainty that is often part of initial treatment decisions," said Randy Vince Jr., M.D., MS Society of Urologic Oncology (NCI T32) Fellow, University of Michigan, and the paper’s lead author. "The findings from our analysis, which show that men with high Decipher scores are more likely to transition off of active surveillance and are over two-fold times more likely to experience treatment failure after initial therapy, provide evidence that molecular testing could have significant utility in this setting."

The Decipher Prostate genomic classifier is currently being investigated in seven National Cancer Institute-sponsored, Phase 3, prospective, randomized controlled clinical trials; 13 Phase 2/3 prospective trials; and more than 20 retrospective studies of Phase 3 randomized controlled trials. Many of these trials require Decipher Prostate testing for study inclusion.

Veracyte did not sponsor the MUSIC study nor play a role in the risk analysis.

About Decipher Prostate

Decipher Prostate (Decipher Prostate Biopsy and Decipher Prostate RP) is a 22-gene, whole-transcriptome-developed genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis and after surgical removal of the prostate. The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.