The level of evidence for the use of biomarkers in the early detection of prostate cancer.

To systematically review the evidence for the use of PSA and other biomarkers in the early detection of prostate cancer, we searched PubMed for clinical trials and studies assessing PSA and other biomarkers in the early detection of prostate cancer, published between 2000 and May 2013 that included >200 subjects.

The level of evidence (LOE) for clinical utility was evaluated using the tumor marker utility grading system. A total of 84 publications, corresponding to 70 trials and studies were selected for inclusion in this review. We attributed a level of evidence (LoE) of IA to PSA for early PCa detection, but we do not recommend its use in mass screening. Emerging biomarkers were assessed in prospective case-control and cohort studies: PCA3 (n=3); kallikreins (n=3); [-2]proPSA (n=5); fusion oncogenes (n=2). These studies used biopsy results for prostate cancer to determine specificity and sensitivity, but they did not assess the effect on PCa mortality. The LoE attributed was III-C. PSA can be used for early prostate cancer detection but mass screening is not recommended. Studies on other biomarkers suggest that they could be used, individually or in combination, to improve the selection of patients with elevated PSA levels for biopsy, but RCTs assessing their impact on prostate cancer management and mortality are needed. A better use of available tests is possible for men at risk in order to maximize the risk-benefit ratio.

Annales de biologie clinique. 2016 Apr 01 [Epub]

Pierre-Jean Lamy, Anne-Sophie Gauchez, Laurent Salomon, Margaret Haugh, Jocelyn Ceraline, Yvonne Fulla, Agnès Georges, Stéphane Larré, Sylvain Loric, Elisabeth Luporsi, Pierre-Marie Martin, Catherine Mazerolles, Vincent Molinié, Pierre Mongiat-Artus, Jacques Piffret, François Thuillier, Paul Perrin, Xavier Rebillard

Unité de recherche clinique , Clinique Beau Soleil, Montpellier, France, Institut médical d'analyse génomique, Labosud-Ocbiologie, Montpellier, France., Institut de biologie et de pathologie, CHU Grenoble, UMR-S Inserm 1039, Grenoble, France, Groupe de biologie spécialisée, Société française de médecine nucléaire, Paris, France., Service d'urologie, APHP CHU Henri Mondor, Créteil, France., MediCom Consult, Villeurbanne, France., UMR_S 1113, FMTS, Université de Strasbourg, Strasbourg, France., Groupe de biologie spécialisée, Société française de médecine nucléaire, Paris, France., Médecine nucléaire, CHU Bordeaux, France., Service d'urologie, CHU de Reims, Reims, France., Biochimie clinique et génétique, APHP CHU Créteil, France., Service d'oncologie, Centre Alexis Vautrin, Nancy, France., Laboratoire de transfert d'oncologie biologie, APHM, Marseille, France., Laboratoire d'anatomie et cytologie pathologiques, IUCT Oncopole 1, Toulouse, France., Laboratoire d'anatomie et cytologie pathologiques, CHU La Meynard Fort de France, France., Service d'urologie, APHP, CHU Saint-Louis, Paris, France., Association française d'urologie, Paris, France., Société française de biologie clinique et Collège national de biochimie des Hôpitaux Paris, France., Service d'urologie, Hôpital Lyon-Sud, Hospices Civils de Lyon, Lyon., Service d'urologie, Clinique Beau Soleil, Montpellier, France.

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