Prospective evaluation plan for randomised trials of prostate cancer screening. The International Prostate Cancer Screening Trial Evaluation Group.

To enable pooled analyses of continuing and planned randomised trials of prostate cancer screening, guidelines for minimal data required for such analyses were developed in the recent meeting of the International Prostate Screening Trial Evaluation Group (IPSTEG). The aim of the pooled analysis with data on individual level will be: (a) Estimation of the effect of screening on prostate cancer mortality with greater precision than individual studies (b) Assessment of optimal screening procedures and interval (c) Identification of subgroups within the populations that might receive most benefit from screening (d) Evaluation of the quality of life effects and cost effectiveness of screening. All studies included in the combined analysis share a common core protocol with minimum data requirements. The protocol allows, however, adaptation of the procedures to local circumstances within defined options. It should be noted that the process is continuing and the protocol is subject to evaluation and revision in the meetings of the IPSTEG on a regular basis.