Introduction

The Decipher test was extensively validated for the prediction of metastasis after radical prostatectomy, and has recently become available for use in biopsy specimens to aid in treatment selection for newly diagnosed patients. A recent study reported that patients with high-risk biopsy Decipher score (>0.60) had a 25% cumulative incidence of metastasis at 5 years post-biopsy. The objective of the current study was to examine the distribution of Decipher scores in a prospective biopsy population, including the proportion of low- and intermediate-risk patients who fall into the Decipher high-risk category.

Methods

From February to August 2016, de-identified Decipher test results were recorded for 1,558 consecutive biopsy specimens. Pathological re-review was performed centrally for 77% of these cases. Decipher scores were classified as low (<0.45), intermediate (0.45-0.60) and high (>0.6). Fisher’s exact test was used to examine the association between biopsy Decipher and clinical variables.

Results

Of 315 patients classified as NCCN low-risk, 57% also had low Decipher scores, while 26% and 17% were classified as Decipher intermediate and high-risk, respectively. Among NCCN low risk patients with high Decipher scores, 45% harbored Gleason pattern 4 on pathology re-review. After excluding patients regraded as Gleason pattern 4 disease, 62%, 25% and 13% had low, intermediate and high-risk Decipher scores. Among NCCN intermediate risk patients, 36% had high Decipher scores. Decipher showed a significant risk differential between favorable and unfavorable sub-groups with 43% and 34% classified as Decipher low-risk (p=0.014). Conversely, high Decipher scores were recorded for 33% of NCCN favorable intermediate-risk and 44% of NCCN unfavorable intermediate-risk patients.

Conclusions

In this prospective analysis, high biopsy Decipher scores were found in close to 1/5 of patients with low and favorable intermediate-risk disease who might be considered candidates for active surveillance. Due to heterogeneity in pathologic assessment, Decipher provides an additional objective metric for proper risk stratification prior to treatment decisions. Future studies are needed to examine the long-term outcomes in these patients, and potential changes in decision-making based on Decipher results discordant with clinical risk strata.

Funding

GenomeDx Biosciences