On December 1, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that new data presented today at the 24th Annual Meeting of the Society of Urologic Oncology (SUO 2023) highlight clinical observations and translational research conducted by users of the company’s Decipher Prostate Genomic Classifier (Press release, Veracyte, DEC 1, 2023, View Source [SID1234638096]). These independent, real-world studies provide further evidence supporting the clinical utility of the test in the treatment and management of prostate cancer, particularly for patients considering active surveillance.
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Not all types of prostate cancer require immediate intervention; many can be monitored carefully over time with active surveillance, while more aggressive cancers have better outcomes with treatment. Identifying the appropriate candidates for active surveillance, however, is not always easy, as the clinical indicators used to assess patient risk often do not reliably distinguish between favorable and more aggressive disease.
Researchers at the Washington University School of Medicine in St. Louis presented two posters at the SUO meeting based on separate analyses of their Decipher biopsy cohort of 888 patients with prostate cancer who were seen at their institution between December 2016 and March 2023. In the first study, the researchers analyzed 235 patients who were initially managed with active surveillance, among whom 88 patients ultimately progressed to receive treatment. In evaluating clinical information available prior to treatment, including PSA levels, Gleason score, and results from magnetic resonance imaging (MRI), along with Decipher Prostate Genomic Classifier results, they found that the Decipher Prostate Genomic Classifier score was the only predictor of progression from active surveillance to treatment.
The second study focused on 104 patients who had a multiparametric MRI (mpMRI) result, Gleason Grade Groups 1-3 on biopsy, and Decipher testing prior to treatment with radical prostatectomy (surgery to remove the prostate). The researchers compared all of the available information prior to treatment to determine the best predictor of final pathology after prostatectomy. While multiparametric MRI (mpMRI) is often viewed as prognostic of cancer pathology, this study found that Decipher scores were strongly associated with final pathology, but clinical variables such as PSA levels, Gleason score and mpMRI were not. While mpMRI is often viewed as prognostic of cancer pathology, this study found that only Decipher scores were strongly associated with final pathology, while clinical variables such as PSA levels, Gleason score and mpMRI results were not.
"Accurately predicting disease progression in patients with prostate cancer is essential so they can receive the treatment that is best suited for them," said Eric Kim, M.D., associate professor of surgery at Washington University School of Medicine in St. Louis and senior author of both posters. "Our studies consistently demonstrated that data from the Decipher Prostate Genomic Classifier was more reliably predictive of prostate cancer progression and underlying pathology than any other clinical data available, including MRI."
Two other studies came from researchers at the University of Miami who used the ongoing Miami MAST prospective trial (MRI selection for active surveillance versus treatment; NCT02242773) to better understand cancer progression at the molecular level. In one study, researchers characterized 224 samples from 124 patients based on cancer progression. Assessment with the Decipher Prostate Genomic Classifier and biological insights from the Decipher Genomic Resource for Intelligent Discovery (GRID) research tool indicated that Decipher scoring was associated with grade progression, but not volume progression, of prostate cancer.
Finally, a large-scale, population-based study of over 52,000 patients tested with the Decipher Prostate biopsy test, led by investigators from the University of Michigan, found wide variation in Decipher risk distribution within and across clinical stage groups, suggesting that genomic assessment identified something that the clinical information does not. From this population-based initiative they concluded that integration of the test into clinical care can provide more precise prognosis estimates for patients and lead to better individualized risk assessment.
"We developed the Decipher Prostate Genomic Classifier to provide actionable information that helps guide patient care," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "The data presented at SUO 2023 show how users of our test, conducting prospective research on their own patients, affirm the utility of Decipher in real-world settings. This real-world evidence and scientific research conducted by Decipher users shows how physicians can refine their surveillance or treatment plans based on a more comprehensive view of each patient’s cancer. We are very grateful for the work conducted by these clinician-scientists on behalf of the entire prostate cancer research community."