Novel biomarkers for prostate cancer: An evidence-based review for use in clinical practice.

Prostate cancer is a heterogeneous disease with disparate outcomes. Traditional clinical parameters are limited in their ability to differentiate between these cases, and there is uncertainty regarding management strategies. A number of novel biomarkers have emerged, but how best to use them at the point of care remains confusing. In the present review, we describe the most common novel biomarkers, their key supporting literature, and propose a meaningful algorithm for their use in clinical practice. To identify commercially available prostate cancer diagnostic tests, we carried out a PubMed literature search (through May 2016). Only English-language studies were included. We restricted our search to studies published within the past 10 years in order to focus our review on novel data. Secondary sources were also examined. We identified 12 novel biomarkers and categorized them into broad areas of clinical practice: (i) early diagnosis and screening; (ii) staging and primary treatment selection; (iii) post-treatment risk stratification; (iv) advanced disease prognosis and treatment response; and (v) emerging tests. Most validation studies rely on small retrospective cohorts and carry a high risk of bias; furthermore, most cohorts are restricted to Caucasians, with little to no representation of other geographic, racial or ethnic populations. Novel biomarkers for prostate cancer management, while potentially helpful, should not replace standard clinical information and physician judgment. They are currently best suited to serve as an adjunct to existing management tools. Clinicians should have a sound grasp of each biomarker-based test's indications and limitations.