European Randomised Study of Screening for Prostate Cancer (ERSPC) - section Rotterdam: follow-up and evaluation
07 / 2002 - 07 / 2006
Database Zorg Onderzoek Nederland ZON
The goal of this proposal can be summarised as follows: - Show or exclude an effect of active screening on prostate cancer mortality by contributing to the European Randomized Study of Screening for Prostate Cancer (ERSPC). Study intermediate outcome measures in comparing screening versus control and 1st and subsequent screens. - Improve the current screening procedures. Model the outcomes of the study through the MISCAN system and predict cost and effects of possible nation wide implementation. a. Outline and extent of the problem: Prostate cancer (PC) is a relevant health care problem. In The Netherlands and in most other western countries, PC is the second most frequent cause of cancer death in males. Prior to the use of opportunistic screening in The Netherlands about 25% of PC's were diagnosed with metastatic disease. The incidence-/mortality ratio was 2.1. As in other western countries, the incidence but also the mortality show a slow continuous rise to 6539 new cases and 2458 PC deaths in 1996. The increase in mortality has in part been attributed to an increase in the number of aggressive cancers. In the U.S.A. where opportunistic screening is very frequent, but also in the U.K. where screening is infrequently used, prostate cancer mortality has decreased. In the U.S.A. at least part of this decrease is considered to be the result of opportunistic screening. The level of evidence produced in presently available studies is however considered insufficient to recommend screening as a health care policy. The controversy persists. b. Questions addressed: While recruitment was the major issue during the first 8 years of ERSPC, evaluation is priority during the study period. Issues for evaluation are: mortality and causes of death in the screening versus control arms by yearly linking to databases of CBS and the Rotterdam Cancer Registry (IKR). Comparison with population based Dutch mortality data. Uniform determination of prostate cancer as cause of death (n = ± 2600). Hospital chart based follow-up of PC patients, yearly, estimate including new cases and deaths is n = 1600 per year. Evaluation of intermediate outcome measures (contamination, interval cancers, prognostic factors, QoL), modelling of outcome and cost-effectiveness. Evaluation of screening procedures (PSA 2-4 range). Completion of recruitment (2nd round). c. Target group: 42,377 men age 55-74 of Dutch nationality have been recruited to the trial in 1994-1998. Re-screening takes place in 4-year intervals. The numbers of men in second round screening decreases steadily because of age = 75 years and because of intercurrent deaths. d. Originality: ERSPC is the only study world-wide which has the power to resolve the issue of PC screening and produce valid public health recommendations. The Dutch contribution is essential. The European Randomized Study of Screening for Prostate Cancer (ERSPC) has the main goal of establishing or disproving an effect of screening on prostate cancer (PC) mortality. Rotterdam contributes a cohort of 42,377 men, age 55-74 to the European study which aims at the randomisation of more than 200,000 men between screening/active treatment and a control group. The present proposal relates to the years 9-12 of the Rotterdam section of ERSPC. It entails: a) evaluation at different levels: - monitoring of the trial progress; - evaluation of intermediate outcome measures (prognostic factors, interval cancers, contamination); - evaluation of public health effects, cost-effectiveness; - yearly evaluation of the endpoint of prostate cancer mortality. b) evaluation is based on the continued collection of follow-up data and on linkage with the cancer registry, CBS, PSA labs, PALGA and other databases of about 1,600 prostate cancer cases in the screening and control arm; c) the conclusion of the second round of screening (by 30.6.2004); d) evaluation and further improvement of the screening procedure in particular in the PSA range 2-4 ng/ml (WBO approved). The final evaluation will take place in 2008/2009 or earlier if a confirmed statistical significance is shown. ERSPC is monitored by an international Data Monitoring Committee (DMC).