Study Results

Published Study Results

New publications

Prognostic factors of prostate cancer mortality in the Finnish randomized screening trial. Neupane S, Steyerberg E, Raitanen J, Talala K, Pylväläinen J, Taari K, Tammela TLJ, Auvinen A. Int J Urol Nov 2017
Summary: In this study we compared the impact of prognostic predictors of prostate cancer death between cases diagnosed in the screening and control arms of a screening trial, as well as between screen-detected and other cases of the Finnish prostate cancer screening trial. We found different effect on the outcome of cases detected through screening as those diagnosed otherwise. A high diagnostic PSA and advanced disease carried a poor prognosis especially among the cases detected outside screening even when lead-time was eliminated.

A Four-kallikrein Panel and β-Microseminoprotein in Predicting High-grade Prostate Cancer on Biopsy: An Independent Replication from the Finnish Section of the European Randomized Study of Screening for Prostate Cancer. Assel M, Sjöblom L, Talala K, Kujala P, Taari K, Auvinen A, Vickers A, Visakorpi T, Tammela T, Lilja H. Eur Urol Focus. 2017 Nov 11
Summary: This study assessed  if a panel of four kallikrein markers (total, free, and intact prostate-specific antigen [PSA] and human kallikrein-related peptidase 2 [hK2]) improves predictive accuracy for Gleason score ≥7 (high-grade) prostate cancer among men biopsied for elevated PSA in the Finnish section of ERSPC (FinRSPC). We found that Four kallikrein markers and β-microseminoprotein in blood improve discrimination of high-grade prostate cancer at biopsy in men with elevated prostate-specific antigen.

Impact of PSA threshold and screening interval on PC screening -round 2. Saarimäki L, Hugosson J, Tammela TL, Carlsson S, Talala K, Auvinen A. Published in Eur Urol Focus. 2017
Summary: We compared PC detection rate and PC mortality between the Finnish and Swedish centres and estimated the impact of different screening protocols. The small number of deaths among cases that would have been potentially detectable in Finland with the Swedish protocol (or those that would have been missed in Sweden with the Finnish approach) is unlikely to explain the differences in mortality in this long of a follow-up. A prostate-specific antigen threshold of 3 ng/ml versus 4 ng/ml or a screening interval of 2 yr instead of 4 yr is unlikely to explain the larger mortality reduction achieved in Sweden compared with Finland.

Allopurinol and risk of benign prostatic hyperplasia in Finnish population-based cohort. Kukko V, Kaipia A, Talala K, Taari K, Tammela TLJ, Auvinen A, Murtola TJAccepted to Prostate Cancer and Prostatic Diseases Oct 2017.
Summary: Benign prostatic hyperplasia (BPH) is a common condition, but etiology is partly unclear. We estimated risk of having clinical BPH by use of gout drug in a Finnish population-based cohort of men. Our study does not show any significant evidence between antihyperuricemic medication using and BPH diagnosis or surgery overall. However, in long-term the risk of clinical BPH may be lowered among men using gout medication.

Published Study Results

Greater absolute benefit from PSA screening at 13 years of follow-up in the ERSPC trial not sufficient to justify population-based screening

The third analysis on prostate cancer mortality in the ERSPC trial, published in the Lancet August 2014, shows stable relative (RR=0.79) but larger absolute benefit in follow-up extended to 13 years (two additional years from the previous report).

The ERSPC is the largest randomized trial of screening for prostate cancer with 162,388 men and 900 prostate cancer deaths. Screening is based on regular prostate-specific antigen (PSA) testing every 2-4 years in the intervention arm and usual care with no screening offered in the control arm. The ERSPC trial has previously demonstrated significant reductions in prostate cancer mortality after 9 years and 11 years of follow-up of our trial (Schröder and colleagues publications in the New England Journal of Medicine 2009 and 2012). We now provide updated results truncated at 13 years for men in the core age group of the study, aged 55-69 years at randomization.

In this update of the ERSPC with follow-up truncated at 13 years, a significant 21% relative reduction in prostate cancer was found in intention to screen analyses, and 27% in men who actually attended screening. The absolute risk reduction of death from prostate cancer at 13 years, with 1.28 fewer prostate cancer deaths per 1,000 men randomized was increased by a quarter compared with analyses limited to 11 years. A total of 781 men needed to be invited to screening (“NNI”=number needed to invite) and 27 to be diagnosed (“NND”=number needed to diagnose) with prostate cancer to avert one death from the disease. These numbers are substantially lower compared to previous reports at 9 years (NNI 1410, NND 48) and 11 years (NNI 979, NND 35) demonstrating a larger effect.

The main drawback of screening is the increased risk of overdiagnosis of prostate cancer due to screening, meaning detection of cancers that may not give rise to symptoms or lead to death during the lifetime of a typical man.

Despite showing a clear prostate cancer mortality reduction, the findings are not sufficient to justify population-based screening. We still need further quantification of harms of screening and better strategies to overcome overdiagnosis and overtreatment for both more targeted screening and assessment of prostate cancer risk, such as multivariate risk stratification. In the meantime, well-informed men suitable for screening should have access to PSA-testing if they wish after careful consideration of the pros and cons. Various decision support tools are available online developed for communication of the pros and cons for men considering screening to discuss with their doctors. Multiparametric magnetic resonance imaging holds promise in evaluation of screen-positive men and is being tested in large scale trials.

Published Study Results

Latest findings confirm increased mortality benefit from prostate cancer testing

The European Randomized Study of Screening for Prostate Cancer has published its 11-year follow-up results (New England Journal of Medicine, March 15 2012). Once again, they demonstrate that screening does significantly reduce death from prostate cancer. The latest study confirms that a man who undergoes PSA testing will have his risk of dying from prostate cancer reduced by 29%.

Extended follow up will assess full impact of screening

By increasing follow-up to an average of 11 years, the ERSPC has shown that 31% fewer men than previously indicated would need to be diagnosed with cancer to save one life. So far, only about 30% of all men in the study have died.

If a larger reduction of prostate cancer mortality is seen by further extending the study beyond the current average of 11 years, the ERSPC can determine with greater certainty whether the benefit of screening outweighs the disadvantages.

ERSPC is the world’s largest randomized prostate cancer screening study. It was designed to investigate whether early detection and treatment of prostate cancer might reduce disease-specific mortality and also help to identify men at risk. From 1992, the ERSPC study randomized 162,000 men, aged 55 to 69, across Europe to either a screening arm or a control group. Those screened were given a blood test to detect PSA levels: if it was 3.0ng/ml or more, they were offered a biopsy. Screening took place on average every four years. Mean follow-up was 11 years. more»

This study is fundamentally different from the US-based Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial where at least 44% of participants in the control arm were already PSA-tested prior to being randomized into the study. The PLCO study has been unable to demonstrate any difference in prostate cancer mortality between the two arms of the study.

Original participating countries and details on specific protocols within each country: Belgium, Finland, France, Italy, Netherlands Spain, Sweden and Switzerland.