Veracyte, Inc. (Nasdaq: VCYT) announced today that new data being presented at the American Society for Radiation Oncology (ASTRO) 2021 Annual Meeting suggest the company’s Decipher Prostate genomic classifier identifies patients with clinically high-risk prostate cancer who may require treatment intensification beyond standard-of-care therapy.

The findings, from a pre-specified analysis of biopsy samples taken from prostate cancer patients with clinically high-risk disease who were enrolled in multiple phase 3, prospective, randomized studies, show that Decipher Prostate test scores are independently associated with distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS) in this patient population. After a median follow up of 11 years, men with disease classified as Decipher high-risk experienced substantially less favorable outcomes compared to men with disease classified as Decipher low-risk.

“Clinically high-risk prostate cancer is a heterogenous disease, and having reliable information about individual patients’ prognoses based on their unique tumor biology can help improve shared decision-making,” said Paul L. Nguyen, M.D., of the Dana-Farber Brigham Cancer Center, who presented the data during an ASTRO media briefing today. “The findings we’re sharing at ASTRO are particularly exciting because they are the first to validate use of a gene expression classifier in pre-treatment prostate cancer biopsy samples collected during prospective, randomized clinical trials.”

For the analysis, Dr. Nguyen and colleagues obtained Decipher Prostate scores for 265 biopsy samples from the NRG/RTOG 9202, 9413 and 9902 phase 3 randomized trials. After multi-variable analyses adjusting for age, prostate-specific antigen (PSA) levels, Gleason score, cT-stage, trial and randomized treatment arm, researchers found that Decipher Prostate scores were independently associated with distant metastases (HR 1.24), prostate cancer-specific mortality (1.27) and overall survival (1.12). The cumulative incidence of DM at 10 years was 26%, 15% and 6% for men who were Decipher high-risk, intermediate-risk and low-risk, respectively. Among the subset of patients with a Decipher Prostate score >0.85 (within the “high-risk” range of 0.6-1.0), DM was 29% at 5 years and 41% at 10 years.

“This analysis provides the first clinical evidence that the Decipher Prostate classifier can help physicians and patients make critical, personalized treatment decisions in the post-biopsy, clinically high-risk prostate cancer setting,” said Elai Davicioni, Ph.D., Veracyte’s senior vice president of scientific and clinical operations, Urologic Cancers. “It adds another important piece to the extensive and growing body of clinical data supporting use of the classifier to help inform treatment decisions across the patient’s prostate cancer journey.”

Treatment intensification for men with clinically high-risk prostate cancer and Decipher scores above 0.85 is being studied in the currently enrolling, prospective, phase 3 randomized trial NRG-GU009 (PREDICT-RT), which also studies treatment de-intensification by halving the duration of hormonal therapy in men with Decipher scores 0.85 or less. Along with PREDICT-RT, 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.

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.