AUA 2017: Prospective Study Of Biopsy Decipher Scores In Potential Candidates For Active Surveillance
The Decipher test includes 22 RNA expression biomarkers in PCa. It 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. Recently, a published study reported that patients with high-risk biopsy Decipher score (>0.60) had a 25% cumulative incidence of metastasis at 5 years post-biopsy.
In this study, Dr. Loeb and her coauthors aimed to examine the distribution of Decipher scores in a prospective biopsy population, and to determine the proportion of NCCN low- and intermediate-risk patients who fall into the Decipher high risk category.
The study began in February 2016 and ended on August 2016. De-identified Decipher test results were recorded for a cohort of 1,694 consecutive biopsy specimens. Central pathological re-review was performed for 77% of these cases. Decipher scores were classified as low (<0.45), intermediate (0.45-0.60) and high (>0.6).
Out of the 340 patients classified as NCCN low-risk, 58% also had low risk Decipher scores, while 26% and 16% were classified as Decipher intermediate and high-risk, respectively. Pathology re-review was only available for 534 patients. Among NCCN low risk patients with high Decipher scores (16% of the low risk patients), 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 47% and 36% classified as Decipher low-risk, respectively, (p=0.003). Conversely, high Decipher scores were recorded for 26% of NCCN favorable intermediate-risk and 40% of NCCN unfavorable intermediate-risk patients.
Limitation of this study include lack of long-term follow-up data and unknown performance compared to other available markers. In summary, this prospective study demonstrated that high biopsy Decipher scores were found in close to 1/5 of potential patients considered for AS. Due to heterogeneity in pathologic assessment, Decipher provides further objective data for risk assessment before treatment decisions. It is critical to ascertain whether potential changes are made in decision-making based on Decipher results, discordant with clinical risk features.
Presented by: Stacy Loeb, New York, NY
Written By: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre
Twitter: @Goldberghanan
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA