Prognostic Genomic Tissue-Based Biomarkers in the Treatment of Localized Prostate Cancer

Simple Summary In clinically localized prostate cancer, risk stratification (low-, intermediate- and high-risk) is crucial for the management of such a heterogenic disease, and it is based only on clinicopathologic features (i.e., baseline prostate-specific antigen (PSA), Gleason score and clinical stage of the tumor). New prognostic tools have been developed, mainly based on genomic tissue analysis. The aim of the present overview report is to focus on commercially available tissue-based biomarkers and more specifically on mRNA-based gene expression classifiers: Decipher (GenomeDX Biosciences), Prolaris (Myriad Genetics), and Oncotype Dx (Genomic Health). These new prognostic tests are going to be incorporated in clinicopathologic nomograms to better design the individualized treatment strategy for the cure of localized prostate cancer. In localized prostate cancer clinicopathologic variables have been used to develop prognostic nomograms quantifying the probability of locally advanced disease, of pelvic lymph node and distant metastasis at diagnosis or the probability of recurrence after radical treatment of the primary tumor. These tools although essential in daily clinical practice for the management of such a heterogeneous disease, which can be cured with a wide spectrum of treatment strategies (i.e., active surveillance, RP and radiation therapy), do not allow the precise distinction of an indolent instead of an aggressive disease. In recent years, several prognostic biomarkers have been tested, combined with the currently available clinicopathologic prognostic tools, in order to improve the decision-making process. In the following article, we reviewed the literature of the last 10 years and gave an overview report on commercially available tissue-based biomarkers and more specifically on mRNA-based gene expression classifiers. To date, these genomic tests have been widely investigated, demonstrating rigorous quality criteria including reproducibility, linearity, analytical accuracy, precision, and a positive impact in the clinical decision-making process. Albeit data published in literature, the systematic use of these tests in prostate cancer is currently not recommended due to insufficient evidence.