European Urology Today: March 2023 - Congress-edition

EAU journey on advocacy on prostate cancer Building alliances and preparing for the future

3. Quality of life and health system expenses An important benefit for European publicly funded healthcare systems is that the early detection of prostate cancer saves costs compared to later stage prostate cancer. Even though they need to be repeated, PSA tests and a good quality mpMRI scans are cheaper than treating advanced and metastatic disease, which only marginally improves survival but greatly impacts quality of life. While the cost of robot-assisted radical prostatectomy, which is one of the most used treatments for early prostate cancer, does not exceed €15,000 per patient, the cost of managing patients with castration-resistant, non-curable prostate cancer can be estimated at approximately €140,000 per patient per year, sometimes reaching €300,000 during a patient’s lifetime in Western countries. [2,3,4] 4. Screening decreases mortality The European Randomised Study of Screening for Prostate Cancer (ERSPC) demonstrates that PSA screening reduces disease-specific mortality at 11 years by 21%, which is equivalent to one death prevented per 781 men invited for screening, or one per 27 instances of prostate cancer detected. The evidence shows that after 20 years of follow-up the number of patients needed to screen and diagnose Prostate Cancer decreased to 101 and 13 respectively to prevent one prostate cancer death. [5,6] This decrease in death becomes more and more significant with longer follow-up (A 44% decrease is seen after 14 years of follow-up in the Gothenburg cohort (Hugosson), and 52% after 19 years in the Rotterdam cohort of the ERSPC) . [5,7] Progress has also been made in reducing over- diagnosis through better use of PSA: age-related PSA, PSA density, PSA velocity, availability of free risk calculators (PCPT and ERSPC) +/- molecular biomarkers [8] and the use of MRI before biopsy, which decreases the number of biopsies and detects more significant and fewer insignificant cancers. [8,9] We can reduce overtreatment through active surveillance in 65% of low and intermediate risk, and the use of Nomograms MAP (age, PSA, GG, MRI volume, PIRADS, MRI ECE). [10] 5. Opportunistic Screening does not work The PSA test has been available for over 30 years and is now widely available on the European market. With virtually no organised PSA early detection programmes, the test is currently used in most countries in an opportunistic manner. The evidence demonstrates that opportunistic testing does not have an impact on decreased mortality, is costly, and can be associated with the harms of overdiagnosis and treatment. [11] What are the EAU’s advocacy goals? The aims of the EAU’s advocacy are to encourage a more rational and organised use of PSA testing using risk stratified approaches to decrease prostate cancer deaths, stop increasing rate of too-late diagnosis, stop costly and inefficient opportunistic testing and to improve the quality of life of prostate cancer patients. The first step to achieve this was to update the White Paper on Prostate Cancer in June 2020 to influence the EU’s Beating Cancer Plan. The White Paper built on previous publications from 2019 and 2017. In November 2020, we organised a virtual

Prof. Hein Van Poppel EAU Policy Office Chairman Urology – KULeuven (BE)

hendrik.vanpoppel@ kuleuven.be

In 2021 the creation of the EAU Policy Office was approved at the EAU General Assembly during the EAU22 Virtual Congress in Amsterdam. This was a significant milestone in ensuring that the field of urology is included in political discourse across Europe. The role of the EAU Policy Office is to advocate, that is, to influence policy and legislation on behalf of urologists on issues that have an impact on urological care, to the benefit of and in partnership with patients. A key advocacy priority for the Policy Office has been the inclusion of Prostate Cancer into Europe’s Beating Cancer Plan. On World Cancer Day, 4 February 2020, the President of the European Commission, Ursula von der Leyen, and Health Commissioner, Stella Kyriakides, jointly announced Europe’s Beating Cancer Plan. The plan would cover the whole pathway of cancer, from prevention and early detection to treatment and care to survivorship and quality of life, but it would have a key focus on prevention and early detection.

The Czech minister of health, Mr. Vlastimil Valek, signing the Prague Declaration on Prostate Cancer at the Prostaforum during the Czech EU Presidency,

The future? PRAISE-U What does this mean in practice? The EAU is now leading a consortium that has been funded by the European Commission in EU4Health to support the implementation of the EU Council Recommendations. This project will perform a needs assessment, develop guidelines and quality assurance mechanisms, and support 5 pilots across the EU. More news on this will follow the start of the project on 1 April 2023. References: 1. European Cancer Information System, Prostate Cancer Incidence and Mortality Estimates, 2022, Found at : https://ecis.jrc.ec.europa.eu 2. Cornford, P., et al., EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: Treatment of Relapsing, Metastatic, and Castration-Resistant Prostate Cancer. Eur Urol, 2017. 71(4): p.630-642. 47 3. Forsmark, A., et al., Health Economic Analysis of Open and Robot-assisted Laparoscopic Surgery for Prostate Cancer Within the Prospective Multicentre LAPPRO Trial. Eur Urology 2018. 74(6): p. 816-824. 48 4. Wu B, et al., Cost of care for patients with metastatic castration-resistant prostate cancer initiating on docetaxel versus oral targeted therapies in the United States. Journal of Clinical Oncology, 2018. 36(30, suppl.): p. 88 5. O sses, D.F., et al., Results of Prostate Cancer Screening in a Unique Cohort at 19yr of Follow-up. Eur Urol, 2018 6. Minozzi S, et al. European Code against Cancer 4th Edition: Process of reviewing the scientific evidence and revising the recommendations. Cancer Epidemiol 39 Suppl 1:S11-9, 2015 7. Hugosson J, Månsson M, Wallström J, Axcrona U, Carlsson S, et al., for the GÖTEBORG-2 Trial Investigators, Prostate Cancer Screening with PSA and MRI Followed by Targeted Biopsy Only. N Engl J Med 2022; 387:2126-2137 DOI: 10.1056/NEJMoa2209454 8. Mannaerts CK, et al. Eur Urol Oncol 2018;1:109–17 9. Amin A, et al. J Urol 2020;203:910–7 10. Lantz A, et al. Eur Urol Oncol 2022;5:187–94 11. Arnsrud Godtman R, et al. Eur Urol. 2015;68(3):354-60 12. Van Poppel H, et al. Prostate-specific Antigen Testing as Part of a Risk-Adapted Early Detection Strategy for Prostate Cancer: European Association of Urology Position and Recommendations for 2021. Eur Urol (2021), https:// doi.org/10.1016/j.eururo.2021.07.024

European Prostate Cancer Awareness Day (EPAD) which focused on the early detection recommendations in the White Paper. The following year, the EAU published recommendations: PSA Testing as Part of a Risk-Adapted Early Detection Strategy for Prostate Cancer, which included a risk adapted algorithm. [12] We worked closely with members of the EAU Patient Advocacy Group (EPAG), such as EuropaUomo and the European Cancer Organisation (ECO), ensuring a joint approach to advocacy and fostering awareness on this shared concern. We met in person with a number of Members of the European Parliament (MEPs) to discuss our recommendations as they compiled their report on the Beating Cancer Plan. The EAU collaborated with other stakeholders and with ERSPC to provide information to scientists and academics involved in the evidence review on Prostate Cancer screening commissioned by the Chief Scientific Advisors of the European Commission. We also collaborated with industry funded advocacy campaigns such as the Let’s Talk Prostate Cancer campaign to raise awareness. The support and engagement of National Urological Societies was critical for the success of the advocacy campaign, many of whom contacted their national MEPs and Department of Health or screening committee or public health agency. The National Societies collaboration has been most helpful during the Presidencies of the EU Council. Most recently, the Czech Urological Society collaborated with their national agencies to organise the Prostaforum in Prague in the auspices of the Czech EU Presidency, resulting in the Prague Declaration on Prostate Cancer. Their minister of health, Mr. Vlastimil Valek, also chaired a meeting in December 2022 where the EU Council Screening Recommendations were updated to include Prostate Cancer. What did Europe approve in December 2022? When the new screening recommendations were published, prostate cancer was included on the list of new cancers to be addressed. Specifically, the EU Council recommended that countries should “consider a stepwise approach, including piloting and further research, to evaluate the feasibility and effectiveness of the implementation of organised programmes aimed at ensuring appropriate management and quality on the basis of prostate- specific antigen (PSA) testing for men, in combination with additional magnetic resonance imaging (MRI) scanning as a follow up test.”

President of the European Commission, Ursula von der Leyen, on World Cancer Day.

The previous European cancer plan dated back to the early 1990s, resulting in the EU Council 2003 Recommendation on Screening, but Prostate Cancer received very little attention. Why did the EAU decide to act? 1. Prostate Cancer is an important health problem Prostate cancer is the most prevalent male cancer in the European Union, with approximately 450,000 men being diagnosed each year. Currently one in seven men are diagnosed with prostate cancer by the time they are 74 years old. 2. Prostate Cancer is killing more men than before The 27 EU member states are estimated to experience a 55% rise in relative mortality rates from prostate cancer by 2040 due to demographic change. [1] Currently in Germany it is now the number two male cancer killer behind lung cancer. In the Baltics and Scandinavian countries it is the number one male cancer killer.

Sunday 12 March, 13:50 - 14:00 Thematic Session: The road to evidence-based European policy on early detection of prostate cancer Yellow Area, eURO Auditorium 1

Fig. 1 Structure of the EAU Policy Office

European Urology Today

February/March 2023

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