Commercialized Blood-, Urinary- and Tissue-Based Biomarker Tests for Prostate Cancer Diagnosis and Prognosis

SIMPLE SUMMARY: In prostate cancer diagnosis and prognosis, clinicians often must take decisions on which prostate cancer-suspected patients should undergo biopsy and which prostate cancer-diagnosed patients should undergo treatment, to overcome overdiagnosis and overtreatment. Many biomarker-based tests have been developed and commercialized in order to guide decision-making processes of clinicians. Since a variety of biomarker-based tests are currently available, this review provides an overview of all commercially available tests for prostate cancer diagnosis and prognosis. For the diagnostic setting, the PHI, 4K, MiPS, SelectMDx, ExoDx, Proclarix, ConfirmMDx, PCA3 and PCMT are discussed, while for the prognostic setting, the Prolaris, OncotypeDx and Decipher test are discussed. Following, an overview is provided of the studies available comparing the performance of biomarker tests. Next, the use of biomarker tests complementary to the use of multiparametric magnetic resonance imaging in diagnosis of prostate cancer is discussed, which is an upcoming tool in prostate cancer diagnosis. ABSTRACT: In the diagnosis and prognosis of prostate cancer (PCa), the serum prostate-specific antigen test is widely used but is associated with low specificity. Therefore, blood-, urinary- and tissue-based biomarker tests have been developed, intended to be used in the diagnostic and prognostic setting of PCa. This review provides an overview of commercially available biomarker tests developed to be used in several clinical stages of PCa management. In the diagnostic setting, the following tests can help selecting the right patients for initial and/or repeat biopsy: PHI, 4K, MiPS, SelectMDx, ExoDx, Proclarix, ConfirmMDx, PCA3 and PCMT. In the prognostic setting, the Prolaris, OncotypeDx and Decipher test can help in risk-stratification of patients regarding treatment decisions. Following, an overview is provided of the studies available comparing the performance of biomarker tests. However, only a small number of recently published head-to-head comparison studies are available. In contrast, recent research has focused on the use of biomarker tests in relation to the (complementary) use of multiparametric magnetic resonance imaging in PCa diagnosis.