title: Emerging biomarkers for prostate cancer diagnosis, staging, and prognosis.
abstract: The introduction and widespread adoption of PSA has revolutionized the way prostate cancer is diagnosed and treated.  However, the use of PSA has also led to over-diagnosis and overtreatment of prostate cancer resulting in controversy  about its use for screening. PSA also has limited predictive accuracy for predicting outcomes after treatment and for  making clinical decisions about adjuvant and salvage therapies. Hence, there is an urgent need for novel biomarkers to supplement PSA for detection and management of prostate cancer. Despite the  progress in developing new biomarkers, several obstacles remain before such biomarkers can be clinically used. These  challenges include analytical and regulatory barriers, issues with study design and data analysis that lead to lack  of reproducibility of promising results, and the lack of large scale trials to adequately assess the utility of  promising biomarkers. In this article we discuss the challenges in biomarker research and the statistical considerations  for biomarker evaluation. There is a plethora of promising blood and urine based biomarkers. For the purpose of this  review, we focus on PSA derived forms, human kallikrein 2, Early Prostate Cancer Antigen, Transforming Growth  Factor-Beta  1 and Interleukin-6, Endoglin, PCA3, AMACR and ETS Gene Fusions. These biomarkers have shown promise in early studies and are at various stages of development. However, in the future it is very likely that a panel of biomarkers will be used to  achieve sufficient degree of certainty in order to guide clinical decisions. To be able to be used commercially such a  panel will have to answer clinically relevant questions in a simple and cost-effective way.
authors: Department of Urology, Weill Cornell Medical College, New York-Presbyterian Hospital, NY 10021, USA. sfshariat@gmail.com
authors: Shahrokh F
authors: SF
authors: Shariat
authors: Douglas S
authors: DS
authors: Scherr
authors: Amit
authors: A
authors: Gupta
authors: Fernando J
authors: FJ
authors: Bianco
authors: Pierre I
authors: PI
authors: Karakiewicz
authors: Ilia S
authors: IS
authors: Zeltser
authors: David B
authors: DB
authors: Samadi
authors: Ardavan
authors: A
authors: Akhavan
mesh_terms: D000230:Adenocarcinoma / Q000097:blood* / Q000175:diagnosis / Q000473:pathology / Q000652:urine; D014408:Biomarkers, Tumor / Q000097:blood* / Q000652:urine; D002986:Clinical Trials as Topic; D006801:Humans; D008297:Male; D009367:Neoplasm Staging / Q000379:methods; D011237:Predictive Value of Tests; D011379:Prognosis; D011471:Prostatic Neoplasms / Q000097:blood* / Q000175:diagnosis / Q000473:pathology / Q000652:urine; D012680:Sensitivity and Specificity; D054928:Validation Studies as Topic
chemical_list: D014408:Biomarkers, Tumor