RESEARCH QUESTION

The objective of this investigation is to assess the benefit of prostate cancer screening with the prostate-specific antigen (PSA) test in participants without suspected prostate cancer in respect of patient-relevant outcomes.

CONCLUSION

With regard to all-cause mortality, there was no hint of any benefit or harm of prostate cancer screening with the PSA test in comparison with no such screening. With regard to prostate cancer-specific mortality, the studies using a PSA cut-off value below 4 ng/mL revealed an indication of a benefit of prostate cancer screening with the PSA test. For the other subgroup, there was no hint of any benefit or harm. Since opportunistic prostate cancer screening with the PSA test was common in the control groups of the 2 largest studies using a PSA cut-off value of 4 ng/mL or higher (i.e. high contamination), it is doubtful whether the PSA cut-off value is the actual characteristic which convincingly explains the difference between subgroups. With regard to the outcome of diagnoses of metastatic prostate cancers, there was an indication of benefit. With regard to the outcomes of health-related quality of life and adverse events as well as the consequences of false-negative screening findings, there was no hint of benefit or harm, albeit based on insufficient available data (no data at all). Proof of harm was found for the consequences of overdiagnoses as well as for false-positive screening findings. Prostate cancer screening by PSA test causes harm to overdiagnosed men (men with prostate cancer which does not require treatment) as well as to men with false-positive screening results (men without prostate cancer). Much of screening-related harm arises at an early time and, in many cases, persists lifelong. Prostate cancer screening with the PSA test benefits some men with prostate cancer by sparing them the distress caused by metastatic cancer or delaying the same. However, this benefit arises only after several years. Even these men might experience early treatment-related complications which persist lifelong. It is unclear whether screening leads to any life extension at all in these men. Considerably more men experience overdiagnosis-related harm rather than benefits from prostate cancer screening by PSA test. All things considered, the benefits of prostate cancer screening with the PSA test therefore do not outweigh the associated harms.