On October 4, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from a large, randomized phase 3 trial reinforce the value of the Decipher Prostate Genomic Classifier in helping physicians make more informed treatment decisions for their patients with prostate cancer (Press release, Veracyte, OCT 4, 2023, View Source [SID1234635651]). The findings, presented at the 2023 American Society for Radiation Oncology (ASTRO) Annual Meeting, suggest that the Decipher Prostate test can categorize more accurately risk of patients with clinically high-risk disease to help inform appropriate treatment.
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Data from a second study presented at ASTRO 2023 reveal there is minimal to moderate risk-score correlation between the gene expression signatures of three commercially available genomic classifiers, including the Decipher Prostate test. The study authors suggest that, given the lack of correlation seen in the cross-comparison, the level of evidence supporting each genomic test, per nationally recognized consensus guidelines, should drive utilization.
"The findings presented at ASTRO 2023 add to the large body of evidence, which now includes 12 phase 3 randomized trials, demonstrating the Decipher Prostate classifier’s performance as a tool to help guide therapeutic decisions in prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Furthermore, they reinforce that the substantial level of evidence supporting the Decipher Prostate test can help guide its selection and utilization for patients with prostate cancer."
The first study assessed the prognostic performance of the Decipher Prostate test among clinically high-risk patients with localized prostate cancer from the phase 3, randomized NRG RTOG 0521 clinical trial, who received radiation and two years of androgen deprivation therapy (ADT) with or without docetaxel chemotherapy. Researchers generated Decipher Prostate test scores using biopsy samples from 183 patients, who were followed for a median of 9.9 years.
Results show that only the Decipher Prostate risk score was independently associated with metastasis-free survival (MFS; HR 1.12, 95% CI) and distant metastasis (DM; sHR 1.22, 95% CI), compared to standard risk factors including Gleason score, T-stage and prostate-specific antigen (PSA) level. Additionally, patients with higher-risk Decipher Prostate genomic scores had worse DM (sHR 2.82, 95% CI) compared to those with lower-risk scores. Cumulative DM at 10 years was 27% for those with higher-risk Decipher test scores vs. 9% for those with lower-risk Decipher test scores (95% CI).
"This study reinforces the ability of the Decipher Prostate classifier to improve risk stratification in high-risk prostate cancer, and thereby support more informed, personalized treatment decisions for these patients," said Phuoc T. Tran, M.D., Ph.D., professor and vice chair for research of Radiation Oncology at the University of Maryland School of Medicine, and co-senior investigator for the study.
In the second study, researchers sought to determine whether risk-score correlation between three commercially available gene expression signatures, including the Decipher Prostate Genomic Classifier, which has the highest level of evidence according to clinical practice guidelines, is strong enough to use the three tests interchangeably. Signature scores for the tests were compared in biopsy samples from over 50,000 patients with localized prostate cancer. The results show that there is a minimal to moderate level of correlation between the three gene expression signatures.
"The poor correlation we observed between the three risk scores suggests that these tests may not be used interchangeably, and clinicians should base utilization on the levels of evidence supporting them," said Daniel Spratt, M.D., Vincent K. Smith chair of Radiation Oncology at University Hospitals Seidman Cancer Center and professor and chair of the Department of Radiation Oncology at Case Western Reserve University School of Medicine, and lead investigator for the study.