Affiliations of authors: Department of Urology (FHS, MJR, WJK, CHB), Department of Public Health (HJdK), Department of Clinical Chemistry (BGB), and Department of Pathology (THVdK), Erasmus MC Rotterdam, The Netherlands; Comprehensive Cancer Center, Rotterdam, The Netherlands (RAMD)
Correspondence to: Fritz H. Schröder, MD, PhD, Department of Urology, Erasmus MC, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands (e-mail: e.vandenberg{at}erasmusmc.nl).
Four pilot studies were conducted in Rotterdam, The Netherlands, prior to the initiation of the European Randomized Study of Screening for Prostate Cancer (ERSPC). The main purpose of these studies was to establish the feasibility of randomization and of the testing procedures. The pilot studies were not part of the ERSPC, and they were not carried out according to a predesigned evaluation plan. Here, we present the data from these trials in an effort to prevent publication bias.
The four pilot studies were conducted from October 24, 1991, to November 30, 1993; a total of 2367 men aged 5575 years were identified in the population registry, invited to participate, and, after providing written informed consent, randomly assigned to receive screening for prostate cancer or no screening (control group). Screening procedures varied among the four pilot studies and are reported in detail elsewhere (1). All protocols were approved by the local medical ethical committee. Men who reported that they had been diagnosed with prostate cancer were excluded. Men who were randomly assigned to screening were tested by determination of their serum level of prostate-specific antigen (PSA), a digital rectal examination, and transrectal ultrasonography. Biopsy indications differed among the four pilot studies.
A total of 2367 (38%) of the 6229 invited men agreed to be randomly assigned, and 94.5% of men who had an indication for biopsy underwent the procedure. This proportion varied only slightly between the initial screening and rescreening, which took place at 4-year intervals. Rectal examination and transrectal ultrasonography were not used in the second and third rounds of screening; instead, participants were offered lateralized sextant biopsies if their serum PSA value was 3.0 ng/mL or higher (2,3). Selected data are shown in Table 1. Of the 111 prostate cancers found in men who were randomly assigned to screening, 16 were interval cancers, six occurred in men who were not compliant with biopsy indications during the second or third rounds of screening, and 89 were detected by screening. Interval cancers were defined as cancers found during the screening intervals or within the 4 years after men who had complied with the screening protocol had passed the 75-year age limit. The 16 interval cancers were equally distributed over the approximately 10 years of the total study period. This follow-up period is the same as that envisaged for the ERSPC as a whole. Diagnoses of prostate cancer among men in the control arm were based on cancer registry data and were confirmed by chart review. The differences in treatment between the screening and control arms reflect, in large part, the different stage distributions of prostate cancers in the two arms. The death rate from any cause was not statistically significantly different between the screening and control arms. Prostate cancer deaths were verified by an independent committee whose members were blinded with respect to the randomization assignment. There were 12 verified prostate cancer deaths in the control arm and three in the screening arm. In each of the arms, one patient is still alive with clinically diagnosed metastatic disease.
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REFERENCES
(1) Schröder FH, Damhuis RA, Kirkels WJ, De Koning HJ, Kranse R, Nijs HG, et al. European randomized study of screening for prostate cancerthe Rotterdam pilot studies. Int J Cancer 1996;65:14551.[CrossRef][ISI][Medline]
(2) Schroder FH, van der Maas P, Beemsterboer P, Kruger AB, Hoedemaeker R, Rietbergen J, Kranse R. Evaluation of the digital rectal examination as a screening test for prostate cancer. Rotterdam section of the European Randomized Study of Screening for Prostate Cancer. J Natl Cancer Inst 1998;90:181723.
(3) Schroder FH, Roobol-Bouts M, Vis AN, van der Kwast T, Kranse R. Prostate-specific antigen-based early detection of prostate cancervalidation of screening without rectal examination. Urology 2001;57:8390.[CrossRef][ISI][Medline]
(4) de Koning HJ, Auvinen A, Berenguer Sanchez A, Calais da Silva F, Ciatto S, Denis L, et al. Large-scale randomized prostate cancer screening trials: program performances in the European Randomized Screening for Prostate Cancer trial and the Prostate, Lung, Colorectal and Ovary cancer trial. Int J Cancer 2002;97:23744.[CrossRef][ISI][Medline]
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