Introduction: A dilemma that urologists face is how to determine which patients with prostate cancer need immediate intervention and which patients can be safely placed on active surveillance. Gene expression profile analysis of biopsy tissue has been proposed as a means of providing more accurate risk stratification for low risk prostate cancer. However, there is a general lack of acceptance and standardization around the integration of genomic testing in clinical practice. The Oncotype DX® prostate cancer assay is a commercially available tissue based assay that assesses the expression of key genes across multiple biological pathways predictive of prostate cancer aggressiveness from the diagnostic biopsy specimen, and reports an individual Genomic Prostate Score.
Methods: With the recommendations set forth in this article we aim to standardize operational best practices for the integration of the Genomic Prostate Score into clinical practice. Its purpose is to provide practical guidance to help physicians understand, run, interpret and communicate actionable results to patients.
Results: The Genomic Prostate Score reflects the biology of the underlying tumor to help guide initial treatment decisions at the time of biopsy. This article is based on real-world evidence from the authors' respective experiences at their institutions and practices. The authors were carefully selected based on their depth of experience and knowledge about the Genomic Prostate Score and, as such, it is their expertise that is being leveraged to support the best practices algorithm.
Conclusions: This article provides easy to use, clear-cut and practical guidance for physicians on how to use the Genomic Prostate Score to inform decisions regarding active surveillance.
Keywords: biological assay; genomics; prostatic neoplasms.