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.
RCT Entities:
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.
Authors: Fritz H Schröder; Jonas Hugosson; Monique J Roobol; Teuvo L J Tammela; Marco Zappa; Vera Nelen; Maciej Kwiatkowski; Marcos Lujan; Liisa Määttänen; Hans Lilja; Louis J Denis; Franz Recker; Alvaro Paez; Chris H Bangma; Sigrid Carlsson; Donella Puliti; Arnauld Villers; Xavier Rebillard; Matti Hakama; Ulf-Hakan Stenman; Paula Kujala; Kimmo Taari; Gunnar Aus; Andreas Huber; Theo H van der Kwast; Ron H N van Schaik; Harry J de Koning; Sue M Moss; Anssi Auvinen Journal: Lancet Date: 2014-08-06 Impact factor: 79.321
Authors: Charlotte M McKercher; Alison J Venn; Leigh Blizzard; Mark R Nelson; Andrew J Palmer; Michael A Ashby; Jennifer L Scott; Matthew D Jose Journal: BMC Nephrol Date: 2013-04-12 Impact factor: 2.388