Features and preliminary results of the Dutch centre of the ERSPC (Rotterdam, the Netherlands)

Objective To describe the preliminary results of the Dutch section of a large multicentre study of screening for prostate cancer, the European Randomized study of Screening for Prostate Cancer (ERSPC), initiated in the Netherlands and Belgium in 1991. Materials and Methods After a series of five pilot studies which started in 1991, full-capacity screening started in 1994 with the use of a serum prostate-specific antigen (PSA) determination, a digital rectal examination (DRE) and transrectal ultrasonography (TRUS) as screening tests. Depending on the results and the screening protocol used, men were referred for further examination by sextant biopsies (extended with a seventh biopsy if TRUS showed abnormality). The protocols used, efficiency of the different screening tests, number of cancers detected in the pilot studies, initial screening round and preliminary results of the second screening round are described. Results After the pilot studies it became clear that a study of prostate cancer screening was feasible in the Rotterdam area. The screening protocol was workable and the recruitment rate acceptable (39.5%). An inventory of the population registries of Rotterdam and surrounding municipalities, and the known recruitment rate, made it clear that a contribution of 40 000 men (aged 55-74 years) from the Dutch centre to the ERSPC was feasible. The initial screening round started in December 1993 and lasted until December 1999 (protocol 5-10). In all, 42376 men were randomized and 1014 cancers detected (5.1%). During this screening the protocol was simplified. After evaluating the different screening tests abnormal results of the DRE and TRUS were omitted as an indication for a sextant biopsy. Only a serum PSA level of greater than or equal to3.0 ng/mL is now used as the indication. The second screening round started in December 1997 and continues. To December 2002, 9920 men were screened for the second time, 4 years after their initial screening visit. To date 446 cancers have been detected (4.5%); this round will last to December 2003. Further evaluation of the screening regimen and characteristics of the cancers detected are constantly assessed within the Dutch ERSPC. Meanwhile a third screening round has also been initiated, which will last to December 2007. Conclusion A prostate cancer screening study of the projected magnitude is feasible in Rotterdam; the recruitment rate is acceptable and the screening tests well tolerated. The study has generated many scientific publications and will be of great value in determining whether prostate cancer screening should be part of general healthcare.