On April 17, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published in European Urology Oncology suggest the Decipher Prostate Genomic Classifier could help identify prostate cancer patients who have micrometastatic disease (difficult-to-detect tumor cells that extend beyond the prostate) and who may therefore benefit from systemic treatment intensification (Press release, Veracyte, APR 17, 2023, View Source [SID1234630178]). The data show that, in men with high-risk and very high-risk disease, Decipher Prostate scores are highly correlated with upstaging predictions made by a clinical algorithm shown to predict prostate-specific membrane antigen (PSMA) positron emission tomography (PET) positivity.
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"Prostate cancer patients with clinically high-risk and very high-risk disease are prone to treatment failure due to micrometastatic disease that was not detected at the time of initial presentation, so it is imperative that we have tools to accurately identify these patients and intensify their treatment accordingly," said Amar U. Kishan, vice chair of Clinical and Translational Research and chief of the Genitourinary Oncology Service, UCLA Jonsson Comprehensive Cancer Center, and an investigator for the study. "Our findings suggest that a high Decipher Prostate score is highly correlated with the risk of having disease outside the prostate identified on advanced molecular imaging. These patients are likely to benefit from upfront systemic treatment intensification. Ongoing clinical trials are designed to prove this."
The 22-gene Decipher Prostate Genomic Classifier provides a score ranging from 0 to 1, categorized as low (<0.45), intermediate (0.45-0.60) and high risk (>0.60) of metastasis. It is the most validated prognostic biomarker for identifying metastatic disease risk among individuals with prostate cancer to help determine who may benefit from treatment intensification. It is currently being evaluated for its role as a predictive biomarker to guide systemic therapy intensification or deintensification in two large, Phase 3 clinical trials (NRG-GU009, NRG-GU010).
In the current study, researchers sought to quantify the association between the risk of upstaging on PSMA PET using a validated clinical algorithm for PSMA PET positivity developed by researchers at UCLA, and the Decipher Prostate score. Using data from 4,625 prostate cancer patients who met the criteria for NCCN high-risk or very high-risk disease or met the high-risk criteria for the STAMPEDE clinical trial, they calculated the probability of upstaging on PSMA PET using the established, validated clinical nomogram, and correlated this risk and individual patients’ Decipher Prostate scores.
The researchers found that there was a significant correlation between patients’ Decipher Prostate scores and the risk of upstaging on PSMA PET, and that high Decipher scores were especially enriched in patients at the highest risk of harboring disease outside their prostate. Accordingly, these patients would be more likely to benefit from systemic treatment intensification as compared to local therapy.
"These findings reinforce the evidence supporting the Decipher Prostate test’s ability to help inform treatment decision-making at initial prostate cancer diagnosis. We look forward to long-term data from ongoing, prospective trials such as NRG-GU009 to help verify the prognostic and predictive power of the Decipher Prostate test to guide treatment intensification or deintensification in patients with high-risk prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.