Decisions on policies for screening for prostate cancer require that information upon health-related quality of life (HRQL) and cost-effectiveness (CE) be available, as the lead time for some of the cases detected by screening will be very long and detriments in quality of life could have a major impact on the subjects remaining life-span. A framework within which both HRQL and cost-effectiveness of prostate cancer screening can be assessed is presented. Studies of both are ongoing in the European Randomised Study of screening for prostate cancer and the US Prostate, Lung, Colon and Ovary trial. Preliminary information confirms that it is important to study screened subjects and controls, and not to assume that inferences derived from study of prostate cancer outside screening trials can be extrapolated to the trials. However, it will require prolonged study to enable the overall effects on quality of life, and on cost-effectiveness to be determined. Such studies are ongoing for the two trials.