Volume 10, Number 1Review ArticlesClinical Utility of Prostate Carcinoma Molecular Diagnostic TestsDiagnostic UpdateScott B ShappellInstead of relying on serum prostate-specific antigen (PSA) to identify patients for prostate biopsy, new laboratory tests are needed that have improved specificity for prostate carcinoma (CaP), allow accurate classification of clinically insignificant CaPs, allow for detection of clinically significant CaP in patients without elevated serum PSA, and allow for identification of aggressive forms of CaP, which may warrant adjunctive or even molecularly targeted therapy in the future. Over the last several years, highthroughput gene expression profiling and proteinomics have led to the identification of genes and proteins that are specifically overexpressed in CaP. Molecular diagnostic techniques readily translated to the clinical laboratory have been incorporated into the development of new tests based on these novel molecular alterations in CaP. Some of these tests already have well-documented clinical utility, such as in facilitating prostate biopsy decisions, and are routinely available. The current review focuses on the biological, clinical, and laboratory aspects of the most promising of these current and nearfuture molecular CaP tests. [Rev Urol. 2008;10(1):44-69]Molecular diagnosticsProstate carcinomaProstate cancer antigen 3Alpha-methylacyl-CoA racemaseEarly prostate cancer antigenTransmembrane protease,serine 2ERGDNARNA
Volume 16, Number 4Review ArticlesA Guide for Clinicians in the Evaluation of Emerging Molecular Diagnostics for Newly Diagnosed Prostate CancerDiagnosis UpdateMichael J KemeterPhillip G FebboSteven E CanfieldAdam S KibelH Jeffrey LawrenceJudd W MoulProstate-specific antigen (PSA) screening is associated with a decline in prostate cancerrelated mortality. However, screening has also led to overdiagnosis and overtreatment of clinically insignificant tumors. Recently, certain national guidelines (eg, US Preventive Services Task Force) have recommended against PSA screening, which may lead to a reverse-stage migration. Although many prostate tumors are indolent at presentation, others are aggressive and are appropriate targets for treatment interventions. Utilization of molecular markers may improve our ability to measure tumor biology and allow better discrimination of indolent and aggressive tumors at diagnosis. Many emerging commercial molecular diagnostic assays have been designed to provide more accurate risk stratification for newly diagnosed prostate cancer. Unfamiliarity with molecular diagnostics may make it challenging for some clinicians to navigate and interpret the medical literature to ascertain whether particular assays are appropriately developed and validated for clinical use. Herein, the authors provide a framework for practitioners to use when assessing new tissue-based molecular assays. This review outlines aspects of assay development, clinical and analytic validation and clinical utility studies, and regulatory issues, which collectively determine whether tests (1) are actionable for specific clinical indications, (2) measurably influence treatment decisions, and (3) are sufficiently validated to warrant incorporation into clinical practice. [Rev Urol. 2014;16(4):172-180 doi: 10.3909/riu0644] © 2014 MedReviews®, LLCProstate cancerBiomarkerClinical utilityGenomic prostate scoreAdverse pathologyClinical validationMolecular diagnostics