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Clinical Trial
. 1995 Jul 1;76(1):129-34.
doi: 10.1002/1097-0142(19950701)76:1<129::aid-cncr2820760120>3.0.co;2-1.

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

F H Schröder  1 , L J Denis, W Kirkels, H J de Koning, B Standaert
Affiliations
Clinical Trial

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

F H Schröder et al. Cancer. .

Abstract

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.

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