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Current State of Genomic Assays to Improve Risk Stratification in Newly Diagnosed Prostate Cancer: A Multidisciplinary Review and Recommendations

Crawford D, David A, Ketan B, Steven C, Greg H, et al.

Although prostate cancer (PCa) has surpassed lung cancer as the most common malignancy in men, many patients have indolent disease that is unlikely to threaten their health during their natural life span. The vast majority of men with PCa are diagnosed at a clinically localized stage and with a lower likelihood of recurrence (metastases/ death) however the majority of men are given immediate intervention primarily due to uncertainty of their cancers’ malignant potential. Over-treatment of low-risk disease with immediate intervention leads to significant morbidities, quality of life impairment, and health care expenses.

“Pro”active surveillance is a viable treatment alternative for men with low-risk PCa. However, confidently making the decision to choose pro-active surveillance requires effective tools to assess the risk of disease aggressiveness at diagnosis. Clinicopathologic risk stratification guidelines or nomograms are conventional tools used in clinical practice. Although effective, they have inherent challenges, such as their ability to provide personalized risk assessment. Population based tools, while easy to use; lose predictive power when collapsing large variables into one category.

Incorporation of genomic assays with clinicopathologic risk assessment tools affords better risk stratification for patients based on their likelihood of progression and disease-specific mortality. Thus, allowing men with more indolent disease to consider being treated more conservatively, while those with more aggressive disease to be afforded the benefits of immediate intervention.

Oncotype DX® Genomic Prostate Score (GPS) and Prolaris® are clinically validated genomic assays used in patients with low risk disease who are considering active surveillance. Other pertinent assays to consider in this setting include DecipherTM and ProMarkTM. Many physicians are unfamiliar with these assays and there is a lack of consensus regarding their role in clinical practice. This manuscript aims to review current evidence and identify recommendations for their clinical utility in the newly diagnosed, positive biopsy, PCa setting.