On February 15, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that data published in the International Journal of Radiation Oncology, Biology, Physics (aka, "The Red Journal") demonstrate that the company’s Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer (Press release, Veracyte, FEB 15, 2023, View Source [SID1234627270]). The data, from a pre-specified analysis of three phase 3 trials, represent the first validation of any gene-expression biomarker on pre-treatment biopsy samples from prospective randomized trials, and suggest the Decipher test provides clinically useful prognostic information to help personalize shared treatment decision-making.
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Approximately 30% of men with newly diagnosed localized prostate cancer present with high-risk disease, meaning they have an increased risk of disease recurrence, metastasis and death compared to men with lower-risk disease. However, previous studies have shown that more than 70% of men with high-risk prostate cancer who receive standard-of-care definitive radiotherapy and long-term androgen deprivation therapy (ADT) will never develop metastatic disease.
"High-risk prostate cancer is heterogenous and standard prognostic tools do a poor job of discriminating which men are likely to develop distant metastases and may benefit from more aggressive therapy, and who will do well when treated with standard radiotherapy and ADT," said Paul L. Nguyen, M.D., vice-chair for Clinical Research in the Department of Radiation Oncology at The Dana Farber/Brigham Cancer Center and professor at Harvard Medical School, and lead author of the published manuscript. "Because of this, clinicians are forced to use a one-size-fits-all approach that inherently leads to under- and over-treatment of many men. The data published today validate the role of the Decipher Prostate test in more accurately prognosticating patient outcomes, even within a high-risk group, to better personalize care. This utility is being further examined prospectively in ‘PREDICT-RT’, two parallel, randomized phase 3 clinical trials conducted by NRG Oncology and sponsored by the National Cancer Institute."
The Decipher Prostate Genomic Classifier is a 22-gene prognostic biomarker that provides a low, intermediate or high score indicating the aggressiveness of an individual patient’s cancer, to help healthcare professionals more accurately categorize risk and select appropriate treatment.
For the current analysis, Dr. Nguyen and colleagues obtained Decipher test scores on 265 biopsy samples from men with prostate cancer that was designated "high-risk" by National Comprehensive Cancer Network (NCCN) classification and who participated in one of three NRG Oncology randomized Phase 3, definitive radiotherapy trials (RTOG 9202, RTOG 9413 and RTOG 9902). With a median follow-up of 11 years, the researchers evaluated the association between Decipher scores and participants’ time to distant metastases (DM), prostate cancer-specific mortality (PCSM) and overall survival (OS).
Results demonstrate the Decipher Prostate test was independently prognostic for DM, PCSM and OS, with Decipher high-risk patients experiencing worse outcomes than Decipher low-risk patients on all three endpoints. After adjusting for age, PSA, Gleason score, cT-stage, trial, and randomized treatment arm, the analysis found that the Decipher test scores were independently associated with DM (HR 1.22, 95%CI 1.09-1.36), PCSM (sHR 1.23, 95%CI 1.09-1.39), and OS (HR 1.12, 95%CI 1.05-1.20). Notably, the Decipher test had similar prognostic ability in patients receiving short-term (4 months) or long-term (>24 months) ADT, though the absolute improvement in outcomes varied by Decipher risk. For example, at 10 years, the DM estimates were 31% for short-term vs 20% for long-term ADT in those with higher Decipher Prostate risk scores (an absolute benefit of 11%) but were 7% vs 4% in those with lower Decipher Prostate risk scores (an absolute benefit of 3%).
"This comprehensive analysis of three high-quality, randomized Phase 3 studies demonstrates that the Decipher Prostate Genomic Classifier provides information that can meaningfully impact clinical care for men with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Rigorous analyses and data like these are why we believe the Decipher Prostate test was given ‘Level 1’ evidence status in the NCCN’s most recent prostate cancer guidelines – the only gene-expression test to receive such designation. We believe the new data generated by Dr. Nguyen and colleagues could help physicians considering various treatment options for men with high-risk disease and who desire to tailor the duration and intensity of hormonal therapy for their patients on an individual basis."