[Early detection of prostate cancer: harm verified, benefit not verifiable].

The results of randomized studies on the early detection of prostate cancer and those of a systematic Cochrane review are compiled and interpreted. Some fundamental and inherent weaknesses of screening studies are pointed out and discussed. The meta-analysis of studies involving a total of 321,594 participants shows no reduction in prostate cancer mortality or all-cause mortality, but describes disadvantages such as unnecessary biopsies, overdiagnosis, and overtreatment. A relevant increase in overall mortality cannot be excluded. Even in future trials, the possible reduction of prostate cancer mortality or all-cause mortality by prostate cancer screening will not be detectable because of inherent methodological problems, e.g., an extremely high number of participants are needed. Furthermore, by nature, studies on the early detection of cancer last very long, such that the results are inevitably outdated at the end of the study. There is a risk that studies on the early detection of cancer suggest an advantage and at the same time overlook a relevant increase in overall mortality. Prostate cancer screening also ignores important WHO criteria for screening programs: There is evidence that early treatment of prostate cancer is not better than late treatment. There is no suitable or reliable test to identify the early stages of the disease. The benefit-risk ratio is not clearly favorable, and there is doubt whether the costs and the benefits are in an acceptable balance. There are valid reasons to advise against population-based prostate cancer screening.