Introduction: Although the prognostic significance of the Decipher genomic classifier (GC) has been established in the context of randomized clinical trials and institutional cohorts, less is known about the associations between Decipher testing and oncologic outcomes among patients treated in the real-world practice setting. Methods: We conducted a retrospective cohort study using a novel longitudinal linkage of transcriptomic data from the Decipher GC and real-world clinical data (RWD) aggregated from insurance claims, pharmacy records, and electronic health record data across payors and sites of care. We assessed the associations between Decipher test results and biochemical recurrence (BCR) and metastasis after radical prostatectomy (RP) and prostate biopsy. Kaplan-Meier and Cox proportional hazards regression were used to examine the associations between GC and the study outcomes adjusting for baseline clinical risk factors. Results: We identified 92,976 patients who underwent Decipher testing that were successfully linked to RWD, including 53,871 from biopsy and 39,105 from RP. The median age at biopsy was 68 years (interquartile range, IQR 62-73) and 27.3%, 27.6%, 29.8%, 10.8% and 4.5% were low, favorable-intermediate, unfavorable-intermediate, high-risk and unclassified by NCCN groupings. The GC classified 51.3%, 18.2% and 30.4% as low, intermediate and high risk, respectively. Figure 1 illustrates the distribution of GC scores across Gleason grade group among the entire cohort. Among RP tested patients, the median age was 65 years (IQR 60-69). In this subset, the GC classified 38.6%, 16.9% and 44.4% as low, intermediate and high risk. Among biopsy-tested patients the GC was independently associated with risk of metastasis (hazard ratio, HR 1.22 per 0.1 unit increase in GC, 95% CI 1.19-1.26, p<0.001) in models adjusted for age and NCCN risk group. Among RP-treated patients the GC was associated with risk of BCR (HR 1.14 per 0.1 unit increase, 95% CI 1.12-1.17, p<0.001) and metastasis (HR 1.18 per 0.1 unit increase, 95% CI 1.15-1.21, p<0.001) in models adjusting for age and CAPRA-S. Conclusions: In this real-world study conducted at the national scale, Decipher GC was independently associated with the risk of BCR and metastasis among patients managed in contemporary practice. SOURCE OF Funding: Veracyte Inc.
