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Phillip G FebboView Articles

Volume 16, Number 4Review Articles

A Guide for Clinicians in the Evaluation of Emerging Molecular Diagnostics for Newly Diagnosed Prostate Cancer

Diagnosis Update

Judd W MoulH Jeffrey LawrenceAdam S KibelSteven E CanfieldMichael J KemeterPhillip G Febbo

Prostate-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®, LLC

Prostate cancerBiomarkerClinical utilityGenomic prostate scoreAdverse pathologyClinical validationMolecular diagnostics

Prateek MendirattaView Articles

Volume 9, Supplement 1Review Articles

Current Standard and Investigational Approaches to the Management of Hormone-Refractory Prostate Cancer

New Directions in the Management of Advanced Prostate Cancer

Prateek MendirattaDaniel J GeorgeAndrew J Armstrong

Prostate cancer is a common cause of death in men and remains incurable in the metastatic setting. In 2004, 2 landmark trials using docetaxel-based chemotherapy, TAX 327 and SWOG 99-16, showed a survival benefit for the first time in metastatic, hormone-refractory prostate cancer. Current research suggests that several distinct mechanisms of androgen-refractory disease may converge in patients with disease progression on androgen deprivation therapy. These findings have identified several potential targets for therapeutic intervention. Current standard and investigational treatment options for this disease are discussed, including chemotherapy and rapidly evolving therapies in phase II/III trials involving antiangiogenic therapies, signal transduction inhibitors, immunomodulatory agents, and nuclear receptor targets. In light of a growing array of treatment options and an increasingly chronic natural history, this review supports a multidisciplinary care approach to these patients, including medical oncologists, urologists, and radiation oncologists, to optimize survival and quality of life. [Rev Urol. 2007;9(suppl 1):S9-S19]

ChemotherapyZoledronic acidHormone-refractory prostate cancerAntiangiogenic therapySignal transduction inhibitorsImmunomodulatory agents