A variety of putative prostate cancer markers have been described in human serum, urine, seminal fluid, and histological specimens. These markers exhibit varying capacities to detect prostate cancer and to predict disease course. In order to be considered markers for diagnosis or prognosis of disease course, and to be brought forward for large-scale clinical evaluation, they should fulfill several criteria. Firstly, there should be a biological or therapeutic rationale for choosing the marker, or at least a consistent association with disease presence, disease characteristics such as stage, or disease aggressiveness. Secondly, there should be an assessment of the strength of marker association with disease outcome. Thirdly, the marker should be assessed as an independent predictor in a multivariate analysis.