Study: Decipher Genomic Prostate Cancer Test Correctly Reclassifies 60 Percent of ‘High Risk’ Patients as ‘Low Risk’ and Identifies Patients Four Times More Likely to Develop Metastatic Prostate Cancer

GenomeDx Biosciences announced the publication of data demonstrating its Decipher test outperformed existing risk assessment tools for predicting metastatic prostate cancer in patients following prostate surgery. Decipher more accurately classified prostate cancer patients at risk of developing metastasis compared to conventional clinical variables such as Gleason score and PSA. In the study, Decipher was able to pinpoint a high risk patient group that was four times more likely to have metastatic cancer. Conversely, Decipher reclassified 60 percent of clinically high risk patients as low risk, who were 2.5 times less likely to have metastatic cancer. The accurate classification of patient risk of metastasis is an important advancement toward the identification of patients that should be treated aggressively and those that should not.

Decipher measures 22 genomic biomarkers associated with metastatic cancer to generate a result that indicates the likelihood of metastasis. The result is completely independent of PSA and other existing clinical variables, providing truly new, unbiased and actionable information that physicians and patients can use to make post-operative treatment plans. The study, titled “Validation of a Genomic Classifier that Predicts Metastasis Following Radical Prostatectomy in an At Risk Patient Population,” is in press and available online in the Journal of Urology. Patients can contact their physician now to see if they would benefit from the Decipher test through ongoing clinical studies. GenomeDx expects to make Decipher more widely available to U.S. patients in the third quarter of this year.

The results of the study demonstrate that Decipher could independently forecast which patients developed metastasis and showed better performance over any clinical variable or prediction model for metastasis, all of which carry limitations that can confound treatment decisions. In the study, 60 percent of patients that had a low Decipher result also had a five-year cumulative incidence of metastasis of just 2.4 percent. In contrast, 20 percent of patients with a high Decipher result had a 22.5 percent incidence of metastasis after five years. Interestingly, data suggest that Decipher may identify a subset of men with adverse pathology features that never develop clinical metastasis.

In the prospectively-designed study, 1,010 patients treated with radical prostatectomy between 2000 and 2006 were identified from the Mayo Clinic tumor registry for a case-cohort study design. Genome-wide expression profiles were generated on a random sample of an at-risk population (219 patients, including 69 patients that eventually developed metastasis on study follow-up). Decipher results were generated from the genome-wide profiles from these patients in a blinded fashion.

Separate clinical utility studies indicate that Decipher holds the potential to modify patient management. Researchers have published findings on the impact of Decipher results on postoperative treatment recommendations for prostate cancer patients (Badani, K, et al. Oncotarget 2013).