European randomized study of screening for prostate cancer. Progress report of Antwerp and Rotterdam pilot studies.

BACKGROUND

The feasibility of screening and early detection of prostate cancer are controversial issues at this time. To conduct a randomized screening study with prostate cancer mortality as the major endpoint is one possible solution to the present controversy.

METHODS

Eight pilot studies have been conducted in the Netherlands (Rotterdam) and Belgium (Antwerp) to evaluate the feasibility of a large scale European randomized study of screening for prostate cancer. Randomization and all other administrative steps necessary to conduct a large scale screening study were evaluated in the two centers. Participation rates were from 30%-42%. Essential adjustments in pilot protocols were made during the study and led to significant changes.

RESULTS

Administrative procedures necessary to run a large scale randomized study were successfully established at the two centers. The experience can be used to establish similar procedures in other European countries. Follow-up in the no screening arm and information with relation to the major endpoint, prostate cancer mortality, are not yet available. In the screening arm, detection rates varied from 3.2% to 3.6%. Major changes in the application of the screening tests made during the course of the pilot studies were the use of random biopsies for prostate specific antigen (PSA) values between 4 and 10 ng/ml as well as the biopsy indication for all suspicious lesions in those men with a PSA below 4.0 ng/ml. One-third of all cancer cases were detected in this latter group. The application of the screening tests to men with low PSA values is still under evaluation.

CONCLUSIONS

The pilot studies led to a common, agreed set of minimal requirements for participation in the European study. These features include randomization, PC mortality as major endpoint, age 55-70 years, biopsy policy, rescreening interval, treatment policies, and follow-up. A randomized screening study seems to be feasible in Europe.