Population-based organised prostate cancer testing Swedish experience can help future European programmes
What makes OPT different from a national screening programme? The Swedish OPT programmes are in most aspects identical to a screening programme, but there are some important differences: • The OPT programmes are regional; a Swedish screening programme would be national. • Men invited to OPT receive a letter with a brief, neutral description of the potential advantages and disadvantages that includes a statement that the National Board of Health and Welfare recommends against screening but supports individual, informed decisions about PSA testing; an invitation to national screening programme would inform that the Board considers the advantages to outweigh the disadvantages. • The primary aims of OPT are to organise the widespread unorganised PSA testing, make testing for prostate cancer more efficient and socioeconomically equal, and to fill diagnostic and organisational knowledge gaps. Registration and reporting of diagnostic outcomes are therefore obligatory. The OPT concept is based on the view that learning by doing is better than doing without learning ; a national screening programme would require a more solid evidence base. • The regional OPT programmes may be adapted to regional circumstances. Some regions may use a test algorithm that reduces the need for MRI scanning, others may refrain from starting OPT because of lack of resources; a national screening programme would be uniform and mandatory for all regions. • The OPT programmes are small pilot boats, navigating the waters of an archipelago to gain needed knowledge to safely guide a national screening programme through the fairways of the sea, avoiding shallows and rocky islands. Early experiences Some important learning points from the first three years of regional OPT are: • OPT involves an unimaginable amount of detailed planning. But however well you plan, you will encounter unexpected pitfalls. • Most medical decisions are simple – many organisational matters are difficult. • It’s wise to test the infrastructure by inviting a few birth cohorts in a few pilot projects (small unexpected pitfalls are better than big ones). • Communication with all stakeholders is essential. Stakeholders include the invited men, the public, media, directly involved healthcare professionals (primary care, clinical chemistry, radiology, pathology, urology, oncology), patients organisations, professional societies and related authorities. • Active follow-up is required to make involved urologists manage men in OPT according to the algorithm, or else the algorithm’s performance will be difficult to evaluate (urologists tend to individualise). • Proportions of positive tests and diagnostic outcomes are age-dependent and differ from those in a clinical setting. • Register, report and analyse all outcomes for quality control and research. Some practical considerations Before launching an OPT project, sufficient resources must be secured for all parts of the diagnostic pathway and for the management of the men who are diagnosed with cancer. When we actively invite healthy men, we take upon ourselves
wish to discuss other urological matters should be kindly requested to make an appointment with their general practitioner or urologist. Nonetheless, the OPT offices spend considerable efforts to follow-up the outcome of urology appointments to make sure that no OPT patient
Prof. Ola Bratt Chairman of the Swedish Working Group for Organized Prostate Cancer Testing, University of Gothenburg; Consultant Urologist, Sahlgrenska University Hospital.
receives unwarranted individualised urology follow-up. This may seem
Prostate cancer is one of the most common cancer related causes of death in all European countries. A long, asymptomatic, organ confined stage in combination with the fact that the disease usually is incurable when symptomatic makes screening attractive. The European randomised screening trial showed that screening for prostate cancer may reduce cancer-specific mortality at least as much as screening for breast cancer and colorectal cancer do, but the diagnostic methods used in that trial led to unacceptably high rates of overdiagnosis and overtreatment. In agreement with almost all other national healthcare authorities, the Swedish National Board of Health and Welfare in 2018 recommended against a national screening programme for prostate cancer. But they also acknowledged that unorganised PSA testing was widespread, ineffective and resource demanding. This led the Swedish Ministry of Health and Social Affairs to commission the Confederation of Regional Cancer Centres in Sweden to standardise prostate cancer testing and make it more efficient. The Confederation assigned a national, multidisciplinary expert group, which later the same year outlined the concept of population- based, regional organised prostate cancer testing (OPT) programmes. The first two OPT programmes were launched in 2020 in two of the most populated Swedish regions, Region Västra Götaland (including Gothenburg) and Region Skåne (including Malmö and Lund). Both started in 2020 with inviting all 12,000 plus 9,000 men, aged 50 years [1]. In March 2023, 6 of the 21 Swedish regions have an OPT programme operating. A further 11 regions are planning to start later in 2023. What is “organised prostate cancer testing” (OPT)? The regional OPT programmes report results to a national working group. The working group publishes updated recommendations annually for OPT, which are available online in Swedish and English [2]. The recommendations cover testing, organisation, coordination and quality control. In summary: • OPT programmes are organised within the public, tax-financed, healthcare system. • The target population is men aged 50 to 74 • All men in the target population should actively be informed about the potential pros and cons and offered structured, repeated testing if they opt for testing. • All regional OPT programmes should use the same, nationally agreed, brief information about pros and cons. • The programme should initially invite a few birth cohorts to evaluate the functionality of the regional infrastructure. • T he programme should include all steps from invitation through the diagnostic pathway to biopsy result notification. • A regional OPT office should organise the programme. • A nationally available online administrative system automatically generates invitation letters and letters for notifying test results. • PSA testing intervals, use of MRI, indication for and extent of prostate biopsies, and follow-up should adhere to an algorithm (Figure 1). Individualised management should be minimised to allow for evaluation of the algorithm’s performance. • After a benign biopsy men should be re-invited according to the algorithm, not be followed up in routine healthcare (with a few, specified exceptions). • All results should be registered in the national OPT register for internal quality control, national analysis and research.
unduly bureaucratic, but if men with a raised PSA in the setting of a full-scale OPT/screening programme are “absorbed” into routine urological care, urology services may quickly become congested. This would also make the test algorithm difficult to evaluate. The future The European Union Council’s new recommendation to evaluate the feasibility and effectiveness of organised prostate cancer screening programmes directs the light to the Swedish OPT programmes, as they are specifically designed for this purpose and have been up and running for some years now. We are looking forward to sharing our experiences with others who are in the early phases of planning or launching similar programmes. One forum for exchanging experiences is the EAU initiated PRAISE-U programme, which received a substantial grant
Figure 1: Standard testing algorithm for the Swedish regional organised prostate cancer testing (OPT) programmes [2].
Conclusions We are experiencing a momentous step forward for European prostate cancer care, but the journey to the new EU recommendation has been long and tough. The early pioneers struggled up a rocky slope in heavy mist with rain in their faces. The past decade the mist and clouds have begun to disperse; we have seen glimpses of the mountain top. Now we are standing there on the top, with a magnificent view of the landscape in front of us. The sunshine glitters in the sea at the horizon. We still have many miles ahead of us, but we are walking downhill and see a path that windles in lush valleys towards an evidence-based, unequivocally beneficial, cost- effective prostate cancer screening programme. I’m convinced that we will get there before sunset and that there´s a snug pub with cold drinks waiting for us. The first pint is on me! References [1]. Alterbeck M, Järbur E, Thimansson E, et al. Designing and implementing a population-based organised prostate cancer testing programme. Eur Urol Focus 2022; 8:1568-74. [2]. Confederation of Regional Cancer Centres in Sweden. Recommendations on organised prostate cancer testing (OPT) 2023. [Available at https://cancercentrum.se/ samverkan/vara-uppdrag/prevention-och-tidig-upptackt/ prostatacancertestning/organised-prostate-cancer- testing/.] [3] Auvinen A, Rannikko A, Taari K, et al. A randomised trial of early detection of clinically significant prostate cancer (ProScreen): study design and rationale. Eur J Epidemiol 2017; 32:521-7. [4] Kohestani K, Månsson M, Arnsrud Godtman R, et al. The GÖTEBORG prostate cancer screening 2 trial: a prospective, randomised, population-based prostate cancer screening trial with prostate-specific antigen testing followed by magnetic resonance imaging of the prostate. Scand J Urol 2021; 55:116-24. [5] Arsov C, Becker N, Hadaschik BA, et al. Prospective randomised evaluation of risk-adapted prostate-specific antigen screening in young men: the PROBASE trial. Eur Urol 2013; 64:873-5.
from the EU5Health programme for implementing OPT. The three largest Swedish OPT programmes are associated with PRAISE-U. Although PRAISE-U and the experiences from the Swedish OPT programmes will facilitate the implementation of formal, population-based screening programmes för prostate cancer, it will be many years of hard work before a majority of European men can be offered organised screening. The conditions are very different across the Union’s member states. Some are well prepared, others are not. There also remain some crucial knowledge gaps: some scientific, others organisational. For example: • How do we best use complimentary tests (biomarkers, risk calculators, TRUS with volume measurement to calculate PSA density) to select men with a raised PSA for an MRI? MRI resources are a limiting factor in many countries, so this may be pivotal for the decision whether or not to launch a national screening programme. • What is the optimal use of MRI for men with persistently raised PSA? In the previous screening trials men with a persistently raised PSA had a systematic biopsy every screening round, but there is probably no need to repeat as frequently the MRI in men with a stable PSA and a low PSA density (MRI resources again). • What proportion of invited men will obtain a PSA test and how many of those who do will have an indication for an MRI or a prostate biopsy? These proportions are different in a screening compared with a clinical setting, and they differ between countries, age groups and screening rounds. Reliable data is essential for resource allocation. • Will men comply with the long follow-up intervals in a screening algorithm, or will they obtain parallel PSA testing in general practice or urology? Parallel testing would probably not be cost-effective. • How are adequate MRI reading and biopsy skills secured? Studies have revealed great variations of MRI assessment and targeted biopsy results. Managers of screening programmes should consider applying quality measures such as structured training, audits, and feedback of biopsy results to reporting radiologists. Some of these knowledge gaps will be filled over the next few years by the ongoing screening trials in Finland [3], Sweden [4] and Germany [5], others by the PRAISE-U programme and other population- based OPT programmes (we learn as we go!).
a particular responsibility not to cause any unnecessary harm, such as anxiety during prolonged waiting times.
The mental frame-shift from personalised clinical care to population-based testing may be difficult. We must recognise that we initially deal with men, not patients, and that most men who participate in OPT never become urological patients. Even among men who are investigated for a raised PSA, a minority are diagnosed with cancer. The Swedish “OPT philosophy” is letting men remain men as long as possible to avoid making them patients. Participants are notified of MRI results by an automated standard letter, which means that those with an unsuspicious scan and a low PSA density do not meet a urologist. We believe this routine prevents turning men into patients. Men with a biopsy indication are referred to a contracted urology unit that has agreed to manage OPT patients according to the algorithm. Their instruction is to focus on the biopsy only; men who
Sunday, 12 March 14:20 – 14:30 Thematic Session: The road to evidence- based European policy on early detection of prostate cancer Yellow Area, eURO Auditorium 1
European Urology Today
February/March 2023
9
Powered by FlippingBook