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The most useful tests are those that are actionable in terms of changing the way the clinician manages a particular patient, notes moderator Raoul Concepcion, MD. For patients with prostate cancer, a urine-based biomarker test for prostate cancer gene 3 (PCA3) is currently available, and is approved for patients with a negative biopsy to aid clinicians in the decision for repeat biopsy. Two tissue-based tests are also available: the ConfirmMDx assay and the Prostate Core Mitomic Test. Clinicians use the results of biomarker testing in conjunction with the results of other tests such as MRI, remarks Concepcion.
Kenneth Kernen, MD, considers biomarker testing for patients whose biopsy results come back negative if other aspects of the clinical picture (eg, free PSA level or rate of PSA increase) raise the index of suspicion.
MRI should be conducted at least 6 weeks after TRUS biopsy, notes Michael Williams, MD. Concepcion remarks that the reading of MRIs by radiologists is not standardized, and Philippa Cheetham, MD, adds that dedicated prostate radiologists may identify a higher percentage of suspicious lesions compared with general radiologists in the community.
Neal Shore, MD, notes that although most companies that have released genomic assays have completed many trials to validate their assays, none of the genomic assays have CMS approval. There is a need for prospective trial data demonstrating that the use of genomic assays results in a change in physician behavior, and also trial data regarding cost comparative effectiveness. Shore remarks that the genomic assays will provide clinicians with additional information to use together with other clinical data such as PSA and histopathology results.