“The Red Journal” data validate clinical utility of Veracyte prostate classifier

Veracyte "announced that data published in the International Journal of Radiation Oncology, Biology, Physics (aka, "The Red Journal") validate the clinical utility of the company’s Decipher Prostate Genomic Classifier for helping to guide treatment selection in men with intermediate-risk prostate cancer. The findings are from NRG Oncology/RTOG 0126, a Phase 3 randomized clinical trial of patients with intermediate-risk prostate cancer treated with definitive radiotherapy without concomitant hormone therapy. This is the first randomized study to validate any gene-expression biomarker in this patient population, adding further evidence to support the Decipher Prostate test’s utility. To assess the prognostic performance of the Decipher Prostate test in the intermediate-risk, post-biopsy setting, researchers utilized patient biopsy samples from the NRG/RTOG 0126 National Cancer Institute-sponsored clinical trial. This study enrolled patients with intermediate-risk prostate cancer, and then compared clinical outcomes following randomization to two different doses of radiation therapy (70.2 Gy vs 79.2 Gy) without any concurrent hormone therapy (aka, androgen deprivation therapy, or ADT). Researchers generated Decipher scores for 215 patients from their biopsy samples, then linked the data with clinical outcomes assessing multiple oncologic and survival endpoints. Patients were followed for a median of 12.8 years. Results show that the Decipher Prostate test was independently prognostic for all clinical endpoints, including disease progression (sub-distribution hazard ratio [sHR] 1.12), biochemical failure (sHR 1.22), distant metastasis (sHR 1.28), and prostate cancer-specific mortality (sHR 1.45). Overall, men in the study with higher Decipher Prostate test scores had worse 10-year outcomes with radiotherapy alone compared to men with lower Decipher Prostate test scores. The 10-year rate of distant metastasis among men with lower Decipher Prostate test scores was 4%, as compared to 16% among those with higher scores."