[The unreasonableness of prostate-cancer screening and the ethical problems pertaining to its investigation]

Since the early 1990s, screening with prostate-specific antigen (PSA) testing has increased the incidence of prostate cancer. Any decrease in mortality will not be seen for at least a decade, due to the long natural history of prostate cancer. Death due to prostate cancer is rare, while the prevalence oflocalised tumours is high. The prognosis of these early-detected localised tumours is uncertain, because most patients will die from other causes. Complications of prostate-cancer therapy are common, with high rates of impotence, incontinence and gastrointestinal problems after prostatectomy or radiotherapy. Randomised trials of prostate-cancer screening, notably the 'European randomised screening for prostate cancer' (ERSPC) trial, began with the consent of ethical committees. There is a real uncertainty regarding the benefits of prostate-cancer screening. However, it is clear that these benefits are limited, because prostate-cancer death is rare before the age of 75 years. There is no real uncertainty about the harms of prostate-cancer screening. High prevalence and high rates of treatment complications deduct many disease- and disability-free years from the eligible population (men aged 55-74 years). Therefore, there has been no real uncertainty over the balance of harms and benefits in prostate-cancer screening trials. Days may be added to old age, at the cost of months of disease- and disability-free living. It is not in the best interest of eligible men to participate in these trials. Randomised trials evaluating prostate-cancer screening violate in principle and practice the Helsinki Declaration of the rights of human subjects in medical research.