EUROPEAN RANDOMIZED STUDY OF SCREENING FOR PROSTATE-CANCER - PROGRESSREPORT OF ANTWERP AND ROTTERDAM PILOT-STUDIES

Background. The feasibility of screening and early detection of prosta te cancer are controversial issues at this time. To conduct a randomiz ed screening study with prostate cancer mortality as the major endpoin t is one possible solution to the present controversy. Methods. Eight pilot studies have been conducted in the Netherlands (Rotterdam) and B elgium (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 scre ening study were evaluated in the two centers. Participation rates wer e from 30%-42%. Essential adjustments in pilot protocols were made dur ing the study and led to significant changes. Results. Administrative procedures necessary to run a large scale randomized study were succes sfully established at the two centers. The experience can be used to e stablish similar procedures in other European countries. Follow-up in the no screening arm and information with relation to the major endpoi nt, prostate cancer mortality, are not yet available. In the screening arm, detection rates varied from 3.2% to 3.6%. Major changes in the a pplication 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 f or 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 app lication of the screening tests to men with low PSA values is still un der 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 polici es, and follow-up. A randomized screening study seems to be feasible i n Europe.