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Molecular Biomarkers in Localized Prostate Cancer

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Diagnosis ➤ Commercially available molecular biomarkers (i.e., Oncotype Dx Prostate, Prolaris, Decipher, ProMark) may be offered in situations where the assay result, when considered in toto with routine clinical factors, is likely to impact management. Routine ordering of molecular biomarkers is not recommended (Moderate Recommendation; EB-I). ➤ Any additional molecular biomarkers evaluated do not have sufficient data to be clinically actionable or are not commercially available, thus should not be offered. (Moderate Recommendation; EB-Ins) ➤ The Expert Panel recommends consideration of a commercially available molecular biomarker (e.g., Decipher Genomic Classifier) in situations where the assay result, when considered in toto with routine clinical factors, is likely to impact management. In the absence of prospective clinical trial data, routine use of genomic biomarkers in the post- prostatectomy setting to determine adjuvant versus salvage radiation or to initiate systemic therapies should not be offered. (Moderate Recommendation; EB-I) ➤ In men with newly diagnosed prostate cancer eligible for active surveillance, both MRI and genomics intend to identify clinically significant cancers. The Expert Panel endorses their use only in situations where the result, when considered with routine clinical factors, is likely to impact management. This may include, for instance, in the initial management of men potentially eligible for active surveillance, where each of these approaches may provide clinically relevant and actionable information. These tests may provide information independent of routine clinical parameters and independent of one another. (Weak Recommendation; IC-U-L)

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