MedicalResearch.com Interview with:
Eric A. Klein, MD
Chairman, Glickman Urological and Kidney Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Klein: Prostate cancer is an enigma. While this tumor is the second leading cause of cancer death among American men, most newly diagnosed disease detected by PSA screening is biologically indolent and does not require immediate therapy. Currently, the main clinical challenge in these men is to distinguish between those who can be managed by active surveillance from those who require curative intervention. Current clinical and pathological tools used for risk stratification are limited in accuracy for distinguishing between these scenarios.
An abundance of research in the last decade has provided evidence that genomics can offer meaningful and clinically actionable biological information to help inform decision making, and current National Comprehensive Cancer Network (NCCN) guidelines on prostate cancer endorse the use of commercially available genomic tools for men considering active surveillance. It has been previously shown that the 22-gene genomic classifier, Decipher, accurately predicts the likelihood of metastasis and prostate cancer specific mortality when measured on tissue from radical prostatectomy specimens. In multiple validation studies, it performed with higher accuracy and discrimination compared to clinical risk factors alone.
The current study is the first to examine whether the use of Decipher might aid decision making when measured on biopsy tissue at the time of diagnosis. Men with available needle biopsy samples were identified from a study cohort that previously had Decipher performed on their matched radical prostatectomy tissue. In this cohort of mixed low, intermediate and high risk men, Biopsy Decipher predicted the risk of metastasis 10 years post RP with high accuracy, outperforming NCCN clinical risk categorization, biopsy Gleason score and pre-operative PSA. Furthermore, this study showed that Decipher reclassified 46% of patients into lower or higher risk classification compared to NCCN classification alone. The study also showed that Biopsy Decipher can identify men that are at high risk for adverse pathology as defined by the presence of primary Gleason pattern 4 or greater.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Klein: A growing body of molecular evidence is confirming that not all patients can be accurately characterized for risk of progression by clinical features alone. Several commercially available tools, including Decipher, have now moved early stage prostate cancer in to the precision medicine era, where clinical management decisions are informed by the specific molecular characteristics of a patient’s tumor. Utilization of genomic tests can provide a clearer identification of who is at high risk versus low risk for cancer progression and can increase the patient confidence that active surveillance is a safe choice.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Klein: Additional validation of the Decipher genomic classifier on needle biopsy cohorts is needed.
Urology. 2016 Jan 22. pii: S0090-4295(16)00069-8. doi: 10.1016/j.urology.2016.01.012. [Epub ahead of print]
Decipher Genomic Classifier Measured on Prostate Biopsy Predicts Metastasis Risk.
Klein EA1, Haddad Z2, Yousefi K2, Lam LL2, Wang Q2, Choeurng V2, Palmer-Aronsten B2, Buerki C2, Davicioni E2, Li J3, Kattan MW3, Stephenson AJ4, Magi-Galluzzi C5.
Mohler JL, Armstrong AJ, Bahnson RR, et al., Prostate Cancer, Version 1.2016. J Natl Compr Canc Netw 2016;14(1):19–30
 Karnes RJ1, Bergstralh EJ, Davicioni E, et al: Validation of a genomic classifier that predicts metastasis following radical prostatectomy in an at risk patient population. J Urol. 2013 Dec;190(6):2047-53.
 Klein, E.A., Haddad, Z., Yousefi, K., Lam, L.L., Wang, Q., Choeurng, V., Palmer-Aronsten, B., Buerki, C., Davicioni, E., Li, J., Kattan, M.W., Stephenson, A.J., and Magi-Galluzzi, C., Decipher Genomic Classifier Measured on Prostate Biopsy Predicts Metastasis Risk. Urology. 2016. In Press. pii: S0090-4295(16)00069-8. doi: 10.1016/j.urology.2016.01.012.
 Reichard CA, Stephenson AJ, Klein EA: Applying precision medicine to the active surveillance of prostate cancer. Cancer. 2015 Oct 1;121(19):3403-11.
Dr. Eric Klein (2016). Decipher Genomic Testing Moves Prostate Cancer Prognosis into Precision Medicine Era