Mapping the readiness landscape for prostate cancer screening in Europe: analysis of health system capacity across the PRAISE-U pilots

Summary

Background

Prostate cancer (PCa) remains the most frequently diagnosed cancer and a leading cause of cancer mortality among European men. To support the European Commission's call for organised, risk-stratified PCa screening, the PRAISE-U (PRostate cancer Awareness and Initiative for Screening in the European Union) pilots tested a designated pathway integrating prostate-specific antigen (PSA) testing, risk stratification and magnetic resonance imaging (MRI)-guided biopsy decisions.

Methods

A formative readiness and capacity assessment was conducted across five PRAISE-U pilots in Lithuania, Lower Silesia (Poland), Manresa and Galicia (Spain), and Ireland. Data were triangulated from (1) desk reviews of legislation, screening policies, and relevant documentation; (2) facility-level assessments; and (3) multi-level stakeholder consultations collected between November 2023 and mid 2024. Finally 47 indicators across 11 domains were developed. Indicators were scored on a standardised 0–2 scale, aggregated at the domain level, and visualised using radar plots. The PRAISE-U was registered with ClinicalTrials.gov, number NCT06424275.

Findings

Substantial heterogeneity was observed across sites. Clinical domains (PSA testing availability, diagnostics, treatment, infection control, multidisciplinary teams and active surveillance protocols) scored high across all pilots. However, the programmatic “front-end” elements (awareness activities, eligibility identification, counselling Standard Operating Protocol) and “back-end” elements (systematic tracking of screen-positives, Quality Assurance and registry linkage) were noted weak and heterogeneous across sites. Lithuania demonstrated the highest overall readiness, while other pilots faced challenges in population identification, data governance, and structured follow-up of screen-positive individuals.

Interpretation

While European pilot sites show robust clinical capacity for PCa care, substantial gaps remain in the organisational, data, and quality-assurance components, that warranted an effective population-based, risk-stratified PCa screening.

Funding

This project has received funding from the EU4Health program under grant agreement 101101217, co-funded by the European Union.

Research in context.

Evidence before this study

Before undertaking this study, we searched PubMed/MEDLINE, Embase, Scopus, and Web of Science for studies published between Jan 1, 2000, and June 30, 2025, using terms related to prostate cancer (PCa) screening, risk-stratified screening, prostate-specific antigen (PSA), magnetic resonance imaging (MRI), organised programmes, implementation, health-system readiness, quality assurance, and key performance indicators. Reference lists of relevant articles and European policy documents were also reviewed, with no language restrictions. The available evidence consistently demonstrated growing interest in organised risk-stratified prostate cancer screening as a strategy to improve the balance between benefits and harms compared with PSA-only approaches. Emerging European pilot programmes and policy initiatives also underscored the need for standardised monitoring and evaluation frameworks. However, most published evidence focused on clinical effectiveness, diagnostic performance, modelling, or individual programme components. In particular, there was limited comparative evidence assessing preparedness across multiple domains, including governance, workforce, infrastructure, information systems, quality assurance, financing, and service delivery, within diverse European health-care settings. We therefore identified an important evidence gap regarding the operational readiness of health systems to implement organised risk-stratified prostate cancer screening at scale.

Added value of this study

This study complements our previous work by assessing whether pilot settings are ready to operationalise an organised, risk-stratified PCa screening pathway–and, by extension, whether they are positioned to implement and sustain key performance indicators (KPI)-based monitoring. We conducted a formative readiness and capacity assessment across five PRostate cancer Awareness and Initiative for Screening in the European Union (PRAISE-U) pilots using triangulated evidence from desk reviews, facility-level assessments, and multi-level stakeholder consultations. We operationalised readiness through 47 indicators across 11 domains spanning the screening continuum, and used standardised scoring and radar plots to enable cross-site benchmarking. This provides an actionable readiness landscape that distinguishes strong clinical capacity from gaps in programme-critical enabling functions (front-end and back-end components such as counselling standard operating protocols (SOP)s, systematic tracking of screen-positives, quality assurance (QA), and registry linkage).

Implications of all the available evidence

Our readiness findings indicate that scaling organised, risk-stratified PCa screening in Europe should prioritise investments in programme infrastructure–especially eligibility identification, invitation workflows, balanced information and counselling, systematic follow-up of screen-positives, QA systems, and data governance and linkage (including cancer registry connectivity). Future research should evaluate how targeted strengthening of these enabling functions improves KPI feasibility, programme performance, equity, and sustainability during scale-up.

Introduction

Prostate cancer (PCa) is the most frequently occurring cancer and the third common cause of cancer mortality among European men.¹ PCa incidence has risen globally, largely driven by longevity and advances in screening and diagnostic services; nevertheless, mortality trends have remained heterogeneous across settings, partially due to absence of organised screening programmes and inefficiency of opportunistic testing.² In 2022, European Commission called for member states to adopt a stepwise approach to PCa screening within an organised framework, to explore effective, efficient and equitable strategies for PCa early detection.³ Large randomised trials that used prostate-specific antigen (PSA) testing yielded diverse outcomes: mainly due to previous PSA testing in invited men. Also, concerns exist over false positives, overdiagnosis and issues related to unwarranted biopsy and treatment.^4,5 In contrast to one-size-fits-all PSA testing approach, learnings from long-term follow-up of these trials suggest that organised, risk-stratified approaches, leveraging risk stratification and Magnetic Resonance Imaging (MRI) before biopsy have the potential to retain mortality benefit, while reducing harms.⁶

Although European trials suggest mortality reduction with organised PSA-based screening, the benefit–harm balance depends on screening interval, risk stratification, diagnostic work-up, overdiagnosis, and treatment practices.^7,8 Currently, there are no uniform screening guideline recommendations for implementation.9, 10, 11 Recognising these challenges, the PRAISE-U project (PRostate cancer Awareness and Initiative for Screening in the European Union) aims to implement contextualised screening strategies in different European contexts. PRAISE-U was initiated as a multi-country, multi-disciplinary initiative aiming to design, implement and evaluate a risk-stratified, MRI-based approach to PCa early detection.^12,13 Details of the novel risk-stratified approach adopted in the project have been reported elsewhere.¹⁴

Health systems are complex and adaptive systems, thus requiring robust research and engagement to understand what works in practice (and for whom).¹⁵ The successful implementation of any new public health intervention, particularly complex initiatives such as organised screening, depends not only on its clinical effectiveness but equally on the health system's readiness to adopt and integrate it effectively.^16,17 In this heterogeneous policy landscape, structured evidence on readiness for organised, risk-stratified screening also remains limited. Thus, this manuscript reports the formative readiness and capacity assessment conducted across PRAISE-U pilot sites before implementation of the risk-stratified, MRI-guided screening protocol.

In this study, readiness refers to the extent to which a pilot site has the governance, service-delivery processes, data systems, quality-assurance mechanisms, and stakeholder arrangements needed to initiate and scale the PRAISE-U risk-stratified screening pathway. Capacity, more specifically, refers to the structural and technical resources required for delivery, including PSA testing facilities, MRI, trained radiologists, biopsy services, treatment facilities, multidisciplinary teams, and active surveillance protocols. Our assessment includes both structural capacity domains and process-oriented readiness domains. The need for such assessment is reinforced by variation in PCa screening practices and health systems.

Methods

This formative health-system readiness and capacity evaluation was conducted across all five PRAISE-U pilot sites: Ireland, the Lower Silesian Region in Poland, Lithuania, and the Manresa and Galicia regions in Spain. These sites were selected to account for geographical diversity (including intra-country regional diversity in Spain) and variability in health system organisation with different screening setting. The core screening algorithm included PSA testing, followed by risk stratification before and, if necessary, after MRI, following which a decision for biopsy was made. The details of the study settings, study participants, risk stratification methods and further assessment and surveillance protocols have been detailed earlier.⁹

Data sources and data collection

Data for the readiness assessment were derived from three complementary sources: (1) comprehensive desk-based review, (2) surveys and facility assessments physically conducted at the pilot sites by expert teams,^18,19 and (3) stakeholder consultations held at national, regional and local levels of healthcare. Data were collected in parallel, analysed separately, and combined to inform the results. During the desk review, the research team at the International Agency for Research on Cancer (IARC) [DS & AC] gathered available information on laws, legislations, screening protocols, national cancer control strategies, quality assurance mechanisms, and reports on programme evaluation published by the respective Ministry of Health across the included pilots. This information was complemented with evidence from existing peer-reviewed publications and grey literature identified by the respective pilot teams. We followed a systematic format for data extraction using a predefined desk review checklist. Data obtained through desk review underwent meticulous editing, cleaning and consistency evaluations, which enabled us to identify areas that needed focus during our subsequent facility visits and stakeholder consultations. The findings were then finally synthesised into a summary report especially highlighting the areas requiring modifications and/or improvement to sustain the pilots. Findings were shared with the site teams before the start of pilot implementation.

Following completion of desk review, on-site facility assessments and stakeholder consultations were conducted between November 2023 and mid 2024. We visited selected health care facilities involved at each pilot site in providing screening, further assessment and treatment services. Site visits focused on facilities and services directly involved in the proposed screening pathway, including PSA testing, MRI, biopsy, pathology/urology, treatment, referral, and data-management functions. The visits were led by an expert team comprising researchers from IARC and the PRAISE-U Management Board. A standardised semi-structured face-validated tool was used to guide the facility assessment. The tool captured the availability of services, workforce, equipment, protocols, referral arrangements, quality-assurance mechanisms, and data systems relevant to the PRAISE-U protocol. Findings were documented using field notes and site summaries, cross-checked against desk-review findings and stakeholder consultations, and validated with local site teams before final synthesis.

Following site visits, we conducted multi-level consultations that included macro, meso and micro level stakeholders. At the macro level, this included national and regional screening programme coordinators, Ministry or regional health authority representatives and hospital administrators–where applicable. At the meso and micro-level, clinicians—including urologists, radiologists, laboratory and diagnostic service leads, information-system and registry/data managers, facility administrators, and patient or civil-society representatives were consulted. In each site, stakeholders were identified and mapped by the pilot site team based on their roles in cancer early detection, involvement in PCa early detection, diagnostic assessment, treatment pathways, programme governance and financing, or data-management functions. We utilised a semi-structured interview guide, informed by the World Health Organisation (WHO) health system building blocks,²⁰ to steer the discussions. In each site, the discussions lasted between 90 and 120 min. The consultations explored the barriers and facilitators to PCa screening implementation. Data from desk reviews, facility assessments, and the stakeholder consultations were triangulated, validated by national collaborators, and synthesised into country-specific summaries. The triangulated summaries from the above-mentioned data capture techniques ensured that findings reflected both documentary evidence and lived implementation realities. The data collection process is detailed in Fig. 1.

Fig. 1.

Data collection process.

Assigning health system readiness scores

Indicators were developed deductively from four sources: the operational requirements of the PRAISE-U screening protocol; the WHO Service Availability and Readiness Assessment constructs²¹; CanScreen5 (https://canscreen5.iarc.fr) constructs for assessing the organisation and performance of cancer screening programmes; and expert knowledge of the minimum health-system functions required for organised, risk-stratified prostate cancer screening. The initial indicator set was drafted by the research team (SP and DS) and reviewed iteratively with other researchers at IARC [AC, ACL & IM], site investigators and PRAISE-U experts for relevance, clarity, feasibility, and completeness. A formal Delphi or psychometric validation process was not undertaken, as the tool was intended for formative implementation planning rather than for generating a validated universal readiness index. The tool underwent expert face validation and was refined through feedback from site investigators before application across the pilot sites.

To assess readiness, we identified 47 indicators that were mapped into eleven core domains, representing critical components of the proposed PRAISE-U PCa screening protocol: i) Awareness (two questions), ii) Invitations & Communication (eight questions), iii) PSA Testing (three questions), iv) First level risk Stratification (one question), v) MRI/Second-level Stratification (five questions), vi) Diagnostics (four questions), vii) Treatment (eight questions), viii) Referral (two questions), ix) Active surveillance (one question), x) Quality Assurance (QA–eight questions) and xi) Data management (five questions). These domains collectively captured the entire continuum of care from awareness and screening invitation through diagnosis, treatment, follow-up, data management, and data-driven quality assurance. The domains were deliberately selected to include both structural capacity domains, such as PSA testing, MRI, diagnostics, treatment, and active surveillance, and process-oriented readiness domains, such as awareness generation, invitation systems, referral coordination, quality assurance, and data management.

Data analysis

Data were analysed separately for each pilot site. Majority of the indicators were scored on a three-point scale (0 indicates absence/not implemented/not documented; one indicates partial implementation, non-prostate-specific availability, inconsistent implementation, or availability in some but not all relevant services; and two indicates documented, prostate-specific, consistently implemented capacity or process.). For binary indicators (Yes/No), a simplified scoring of 0 or 2 was used to maintain scoring consistency. Domain-level readiness scores were calculated as the arithmetic mean of the indicators within each domain. Domains were not weighted separately. Scoring was first applied by the central research team using documentary evidence, facility-assessment findings, and stakeholder consultation summaries, and then reviewed with site teams to resolve discrepancies. Formal inter-rater reliability testing was not performed. Radar (spider) plots were used to display each pilot site's results, facilitating comparisons across domains and between pilots. The visualisation facilitated cross-country benchmarking and identification of areas requiring capacity investment. The results from the pilots were combined into a strength, weakness, opportunity and threats (SWOT) analysis that highlighted the PRAISE-U framework's strengths, weaknesses, opportunities, and threats related to the delivery of a risk-stratified, population-based PCa screening pilot and future scale-up. Scoring, analysis and radar plots were done using Microsoft excel version 16.106.3.

Sex and gender considerations

The PRAISE-U screening pathway is designed for prostate cancer early detection and therefore applies to men and persons with a prostate who meet the eligibility criteria of the participating pilot protocols. The present analysis, however, was conducted at the health-system and pilot-site level and did not involve collection or analysis of individual participant-level sex, gender identity, or clinical outcome data. Accordingly, readiness indicators were assessed at the level of programmes, facilities, services, and information systems rather than by individual sex or gender strata. Where relevant, the manuscript uses the term ‘men’ to reflect the target population described in the participating prostate cancer screening protocols.

Ethics and trial registration

The study has been approved by the institutional review board and ethics committee of IARC (conditional approval IEC 23–25, 03/07/2023). The PRAISE-U study was also registered at ClinicalTrials.gov (NCT06424275). Written informed consent was obtained from all participants who participated in the formative phase.

Role of the funding source

The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Results

The readiness scores across all domains and by pilot sites are summarised in Table 1. The scoring details and the description of each indicators are presented as a Supplementary Table S1. All five sites provided information across the eleven domains, but the source and granularity of evidence varied by site and indicator. To improve transparency for cross-site interpretation, whenever, documentary evidence was incomplete during the site visits, information was triangulated using facility assessments and stakeholder consultations, and when no information could be gathered, the indicator was scored as absent or partial according to the predefined scoring rules. Pilot sites had substantial heterogeneity across the domains. Core clinical domains such as PSA testing, diagnostic and treatment services, and infection control were consistently strong across sites, whereas average scores for programmatic components such as awareness generation, counselling services, data management, and quality assurance mechanisms were variable. Lithuania demonstrated the highest overall readiness reflecting a relatively structured and coordinated approach to PCa screening infrastructure. In contrast, Ireland, Poland, Manresa, and Galicia showed comparable strengths in clinical domains but notable deficiencies in eligible population identification and data governance. Further details of the facility readiness as observed from desk review, facility visits and stakeholder consultations are described below.

Table 1.

Summary of domain-level readiness scores across five PRAISE-U pilot sites.

Domain	Indicator	Lithuania	Poland	Manresa	Galicia	Ireland
Awareness	Presence of dedicated awareness team	2	1	1	1	1
	Awareness generation strategies	2	1	1	1	1
Invitations & communication	System to identify eligible population	2	0	2	2	0
	SOPs for counselling after PSA	0	0	0	2	2
	Counselling on benefits and harms	0	0	2	2	2
	Screening invitation system	2	2	2	2	2
	Communication of screening results	2	2	2	2	2
	Reminder system for non-responders	2	2	2	2	2
	Reinvitation for screen negatives	2	2	2	2	2
	Follow up invitation for screen positives	2	2	2	2	2
PSA testing	PSA as primary screening test	2	2	2	2	2
	Organised vs Opportunistic PSA testing	2	1	1	1	1
	Referral pathway for PSA positives	2	0	0	1	1
First-level stratification	Use of risk stratification tool	0	0	0	0	0
MRI/Second-level stratification	Type of MRI used	2	1	1	2	1
	MRI based second risk stratification	0	0	0	0	0
	Trained radiologists	2	2	2	2	2
	Double reading of MRI	0	2	2	0	0
	MRI guided biopsy decision	2	2	2	2	2
Diagnostics	Adequate trained workforce for biopsies	2	2	1	2	2
	Availability of facilities for biopsies	2	2	2	2	2
	Pre/post biopsy counselling	2	2	2	2	2
	Biopsy infection control protocol	2	2	2	2	2
Treatment	Multidisciplinary team (MDT)	2	2	2	2	2
	Adequate trained workforce for treatment	2	2	2	2	2
	Standardised treatment protocols	2	2	2	2	2
	Availability of treatment modalities	2	2	2	2	2
	Treatment infection control protocol	2	2	2	2	2
	Informed consent for treatment	2	2	2	2	2
	Adverse events management SOPs	2	2	2	2	2
	Psychosocial support services	2	2	2	2	2
Referral	Continuum referral pathway	2	1	2	2	2
	Compliance with referral pathway	1	1	2	2	1
Active surveillance	Active surveillance protocol	2	2	2	2	2
Quality assurance (QA)	QA responsibility	2	1	1	1	1
	QA guidelines and standards	2	1	1	1	1
	Monitoring & evaluation system	1	1	1	1	1
	Accreditation of services	2	1	1	1	1
	SOPs for clinical workflow	2	2	2	2	2
	Data quality assurance system	1	1	1	1	1
	Monitoring patient satisfaction	0	0	1	1	1
	Client feedback system	0	0	1	1	1
Data management	Digital medical record system	2	2	2	2	2
	Legislation for data protection	0	0	2	2	2
	Unique identifier/Record Linkage	2	2	2	2	0
	Designated data manager	2	1	1	1	1
	Data linked to cancer registry	0	0	0	0	0

Scores are coded as follows: 0 = absent, not implemented, or not documented; 1 = partially implemented, inconsistently implemented, available only in selected services, or available only in a generic/non-prostate-specific form; 2 = fully implemented, consistently available, and documented or prostate-specific where relevant. Domain-level scores were calculated as the mean of the component indicator scores within each domain. Indicator-level anchors and descriptions are provided in Supplementary Table S1.

PCa = prostate cancer; PSA = prostate-specific antigen; MRI = magnetic resonance imaging; QA = quality assurance; SOP = standard operating procedure.

Generate awareness on screening, invitations and communication

Lithuania had an existing national PCa screening program with a dedicated team responsible for promoting public awareness on PCa and employed strategies such as mass media and one on one education campaigns. Other pilot sites had general cancer awareness initiatives, with no targeted prostate specific campaigns. All sites exhibited strong processes for sending invitations and reminders, communication of results and follow up of screen positives, however Poland, and Ireland reported challenges in identification of eligible population for screening. None of the participating pilots, with the exception of Ireland and Galicia, had a standard operating protocol (SOP) in place for systematic invitation. Lithuania and Poland reported existing gaps in counselling on the benefits and harms of cancer screening among invited individuals.

PSA testing and referral pathways

All sites offered PSA as the primary screening test for PCa. However, screening services were implemented in an organised manner only in Lithuania whereas the other sites had opportunistic PSA testing. Poland and Manresa, Spain did not have a documented referral pathway for individuals with elevated PSA, whereas Galicia, Spain and Ireland had several mechanisms in place, and Lithuania had a clear defined pathway for referral of men with elevated PSA.

Risk stratification (first and second level, including MRI capacity)

None of the pilot sites reported the use of validated risk-stratification tools before diagnostic confirmation, before the PRAISE-U project. The type and application of MRI varied, however, access to MRI services was present at all participating sites. While Lithuania and Galicia used multiparametric MRI (mpMRI), the rest utilised biparametric MRI (bpMRI). MRI was universally available and interpreted by trained radiologists, nevertheless, none of the sites used findings of MRI, as a second-level risk-stratification tool, post-PSA screening. All sites relied upon MRI images to stratify and guide biopsy decision. Only Poland and Manresa had double reading of MRI images.

Diagnosis and treatment

All pilot sites scored uniformly high for diagnostic and treatment readiness domains. All sites reported adequate workforce (radiologists and urologists) for prostate biopsies–with some shortage in Manresa, and sufficient facilities for ultrasound-guided biopsies. Adequate counselling services (before and after biopsy), and effective infection control protocols were in place at all sites. Every pilot site had comprehensive multidisciplinary teams (MDTs) coordinating management decisions, adequately trained specialists, formal treatment SOPs, and a full range of treatment modalities including surgery, radiotherapy, chemotherapy, and immunotherapy. All sites had provisions for psychosocial support to patients and/or their families, and a system to report and monitor adverse-events encountered during PCa treatment.

Referral and continuity of care

All sites had existing referral pathways linking between diagnostic and treatment services, however the level of integration varied widely both within the site and across the sites. Lithuania, Manresa, Galicia, and Ireland reported better referral mechanisms, while such pathways in Poland were fragmented. Only the two Spanish sites reported systematic tracking of screen-positive individuals, whereas the other sites relied upon sporadic follow-up by clinicians. All sites had active surveillance protocols in practice for the follow up of individuals who were diagnosed with low or favourable-intermediate risk PCa after biopsies.

Quality assurance and data management

QA mechanisms were diverse across the pilot sites and often generic and not PCa specific. Lithuania, with designated QA teams and documented guidelines with quality indicators, available laboratory accreditation procedures and clinical SOPs for PCa screening, scored the highest in this domain. Monitoring and evaluation (M&E) mechanisms were in place in all sites but rarely prostate-specific. Both the Spanish sites and Ireland captured and reviewed client feedback and also monitored patients satisfaction. All pilot sites had digitalised medical record system. Existing unique patient identifiers enabled cross-level linkage, with the exception of Ireland, where linkage systems were under development. Ireland and Spain had explicit data-management legislation and privacy policies in place. All pilot sites had designated data managers, who supervised cancer screening records; however, Lithuania demonstrated greater integration, where they were actively engaged in PCa screening data management. Despite widespread digitalisation, none of the sites could link the prostate screening data with national cancer registries.

The graphical representation (spider plot) of the average readiness scores obtained across pilots under each domain are represented in Fig. 2. When viewed holistically, the high scoring domains were the generic cancer pathway components including diagnostics, treatment, and active surveillance, mirroring Europe's robust clinical oncology capacity. In contrast, the core components of population-based cancer control programs such as awareness generation, QA, and data management, along with the newly proposed risk stratification, emerged as the weakest areas, highlighting gaps that required targeted investment.

Fig. 2.

Domain-level readiness scores across PRAISE-U pilot sites. Radar plots display average domain-level readiness scores derived from indicator-level scores within each domain. All domains are displayed on a common 0–2 scale, where 0 indicates absent/not implemented, 1 indicates partial or non-prostate-specific implementation, and 2 indicates full implementation. Identical radial limits were used across all site plots to support direct visual comparison. Higher values indicate greater readiness. QA = quality assurance; PSA = prostate-specific antigen; MRI = magnetic resonance imaging.

Discussion

This study offered a nuanced health-system readiness analysis of the five pilot sites prior to implementation of the risk-stratified PCa screening protocol, developed under the PRAISE-U initiative. To comply with the European Council's recommendations (updated in 2022) to pilot PSA screening and MRI-guided biopsy decisions, findings of this study highlight key areas of health system strengthening required to either commence or scale up the pilot screening program within an organised framework.

Despite strong technical capacity (MRI availability, skilled radiologists, and advanced urological and pathological services), gaps exist in the ‘front-end’ (invitation, record linkage, counselling) and in follow-up and surveillance aspects of the cancer care continuum. This may lead to a void, where the risk of overdiagnosis, overtreatment and inequity compounds.22, 23, 24, 25 In countries that primarily operate opportunistic PSA screening, the absence of standardised invitation systems, tracking of screen positives, and QA has consistently been flagged as a barrier to effective early-detection of PCa.²⁶ For example, a recent systematic review on cost-effectiveness of PCa screening in Europe documented that risk-based screening with MRI appears more cost-effective than arbitrary PSA-only strategies (median Incremental Cost-Effectiveness Ratio [ICER] ∼€56,487/Quality-Adjusted Life Year [QALY]). The current practice of performing MRI on all men with abnormal PSA test without any risk stratification, as observed in our study, will overload the radiology services with the implementation of population-based screening and is unsustainable.²⁷

The study findings also report high heterogeneity across the chosen PRAISE-U pilots to deliver the proposed risk stratified protocol. This emphasises that implementation of the PRAISE-U protocol could not follow a ‘one-size-fits-all’ approach across different health systems. Sites having organised systems in place to deliver PCa screening such as Lithuania, may require fewer additional system investments, focussing on process optimisation; whereas other sites (like Poland) require reforms in invitations, while all sites require strengthening of registry linkage and QA. From a policy point of view, the PRAISE-U algorithm also contributes a proof-of-concept for organised risk-stratified PCa screening across heterogenous health systems. The Swedish organised prostate testing (OPT) experience establishes that existing clinical infrastructure and strong data systems can support organised, population-based screening when paired with well-defined governance, invitation, and standardised care pathways.²⁸

Importantly, this capacity assessment exercise enabled us to tailor implementation strategy for each site in close collaboration with the local stakeholders. This is another example of using implementation science methods and theories in cancer control and should be followed as other EU Member States proceed to pilot risk-based PCa screening.²⁹ The systematic identification of gaps, ranging from the absence of risk stratification, uneven use of bpMRI vs mpMRI, and inconsistent counselling protocols, to fragmented referral pathways and shortages of specialised staff, allowed PRAISE-U project to design site-specific adaptations. This exercise also enabled us empower centres with sub-optimal resources towards a common standard, rather than restricting implementation to high-resource referral centres.

Our findings indicate that, at the system level, countries considering the implementation of risk-stratified PCa screening should make investments in core enablers of screening pathway, beyond diagnostics and clinical services. Organised PCa screening should not be viewed as an add-on to current opportunistic PSA testing, but rather as a redesign of service delivery by local governments and policy makers. Financing must account for invitation workflows, information education and communication (IEC) campaigns, reminder systems, and data-management. Policy makers should also be mindful especially in settings where diagnostic treatment resources are sub-optimal, as increased screening can place incremental demand on MRI, biopsy services and urology and pathology services. At clinical/hospital level, the shift from opportunistic to risk-stratified organised screening mandates changes in primary-care engagement, counselling, and shared decision-making. Thus, the evidence generated will be crucial for determining the feasibility and scalability of organised, risk-stratified PCa screening in more diverse and widespread healthcare settings. The observed readiness gaps also have important equity implications. Organised screening can reduce inequities only if the programme architecture ensures equitable access across the whole care continuum. Readiness should therefore extend beyond clinical infrastructure, to include the capacity to reach underserved groups and to monitor differential participation and outcomes by geography, socioeconomic position, ethnicity or race, migration status, language, disability, and digital access. Finally, being a formative pre-implementation assessment, the primary purpose was not to establish a predictive scoring model, but to generate an actionable implementation tool to identify the specific system gaps that could interrupt the prostate cancer screening continuum and to guide corrective action before and during pilot delivery. The readiness findings are therefore being used to work closely with country implementation teams to strengthen weak points in the pathway and to determine whether identified bottlenecks are being addressed during implementation.

The study has several strengths. The formative assessment brings a multi-site, comparative health-system readiness of five pilot sites from four European countries with differing governance, financing and screening practices to deliver an organised risk stratified PCa screening protocol. By assessing 11 domains via standardised scoring and stakeholder validation, we provide actionable insights into system readiness beyond simple descriptions of technical capacity. Triangulation of multiple data sources; desk reviews, facility assessments, and stakeholder consultations adds validity to the findings. Finally, the health system lens applied throughout the analysis, helps to ascertain operational bottlenecks that often determine the success or failure of a screening program. However, the study also comes with several limitations. The scoring system on 2 for ‘Yes’ and 0 for ‘No’ is over-simplified, which may under- or over-estimate readiness in certain domains. The data are cross-sectional and reflect readiness prior to implementation of PRAISE-U, and we acknowledge that capacity may evolve due to dynamic changes. The findings of the current study are most directly applicable to well-resourced European regional health systems with established urological, radiological, pathology, and oncology infrastructure. Although the included pilot sites provides diversity in the infrastructural landscape, they should not be interpreted as representative of all European or global settings. Application of this readiness framework in lower-resource settings or differently organised health systems would require adaptation, and in such settings, such a readiness assessment exercise might serve as a staged planning tool to identify minimum requirements before introducing risk-stratified screening, rather than as a benchmark against well-resourced pilot sites.

In conclusion, this comparative readiness assessment across five European pilot sites revealed that diagnostic and treatment infrastructure for PCa were quite strong, however, the domains such as awareness & communication, invitation systems, risk stratification, data linkage & QA represented key implementation bottlenecks, that needed attention. The PRAISE-U risk-stratified screening protocol provides an important opportunity to catalyse system integration to drive towards population-based organised screening for PCa in Europe.

Contributors

SP, AC, and PB conceptualised the study, led the data analysis, interpreted the findings, and drafted the manuscript. DS, AC, IM, ALC, and PB led the data collection and contributed to study design, data interpretation, and manuscript development. SP conducted the data analysis with contributions from DS, AC, IM, ALC, and PB. JV, AP, KT, AGA, MTA, MCQ, DG, RVDB, MJR, LDFV, SC, and HVP contributed to study implementation across participating centres (JV, AP, KT, AGA, MTA, MCQ, DG), interpretation of findings (JV, AP, KT, AGA, MTA, MCQ, DG), and critical revision of the manuscript for important intellectual content (RVDB, MJR, LDFV, SC, HVP). Members of the PRAISE-U consortium contributed to the design (RVDB, MJR, LDFV, SC, HVP), coordination (RVDB, MJR, LDFV, SC, HVP), implementation and monitoring (RVDB, MJR, LDFV, SC, HVP) of the study across participating sites. SP and AC accessed and verified the underlying data. All authors contributed to the drafting or critical revision of the manuscript, approved the final version for publication, had full access to all study data, and had final responsibility for the decision to submit the manuscript for publication.

Data sharing statement

The data that support the findings of this study are available on request.

Declaration of interests

Ángel Gómez Amorín received an honorarium for participating in a round table discussion on prostate cancer screening at the XXXVII Annual Meeting of the Galician Society of Oncology. All other authors declare no conflicts of interest.