Bridging the PSMA PET/CT access gap in prostate cancer: evidence, barriers, and priorities for implementation

Abstract

Purpose

To examine the gap between evidence-based indications for PSMA PET/CT and real-world access in prostate cancer, with a focus on European implementation and country-specific experience from Spain and France.

Methods

A focused narrative appraisal of published evidence, clinical guidelines, regulatory and reimbursement information, and real-world accessibility data was performed. European accessibility modelling and physician market research from Spain were incorporated to characterise implementation patterns and barriers.

Results

Access to PSMA PET/CT remains heterogeneous despite its established role in higher-risk staging and biochemical recurrence. Reported barriers include reimbursement and local approval requirements, PET/CT and nuclear medicine capacity, radiopharmaceutical logistics, non-standardised referral pathways, waiting times, and institutional variation. Exploratory modelling suggested that use remains below the estimated eligible population in both staging and biochemical recurrence, with differences between countries and clinical scenarios. Spanish market research similarly indicated substantial variation. These data are exploratory implementation signals rather than population-level epidemiological estimates.

Conclusion

Improving access requires guideline-based eligibility criteria, harmonised reimbursement, regional referral networks, adequate imaging and reporting capacity, reliable tracer supply, and measurable access indicators. Further research should determine whether reducing implementation gaps improves diagnostic pathways and treatment allocation.

Introduction

Imaging is central to prostate cancer care because disease extent informs treatment selection, radiotherapy planning, surgery, systemic treatment, and assessment of recurrence. CT, bone scintigraphy, and MRI remain widely available but have limitations for detecting small-volume nodal or distant disease and localising recurrence.

PSMA PET/CT has substantially changed the imaging approach to prostate cancer staging and restaging. In high-risk localised disease, the randomised proPSMA trial demonstrated greater diagnostic accuracy than CT and bone scintigraphy (92% vs. 65%) [1]. In biochemical recurrence, PSMA PET/CT can detect disease at PSA levels at which conventional imaging is frequently negative, and its use is increasingly incorporated into guideline-based staging and recurrence pathways [2–5].

Technical availability does not ensure equitable access. Patients with similar clinical characteristics may follow different pathways according to country, region, hospital type, reimbursement, nuclear medicine capacity, local protocols, and referral organisation. A recent European expert perspective from our group highlighted the need to move from demonstrating diagnostic value to achieving timely implementation [6]. The present review extends that work with accessibility estimates, reimbursement and implementation data, proposed access metrics, and a detailed Spain-France analysis.

For this review, access means the ability of a clinically eligible patient to undergo guideline-concordant PSMA PET/CT within a timeframe that allows the result to inform treatment, regardless of geography, institution, or payer pathway. We review the clinical rationale for access, implementation barriers, real-world signals, and priorities for more timely and equitable delivery.

Evidence acquisition

This narrative review was based on a focused appraisal of published evidence, clinical guidelines, regulatory and reimbursement information, and real-world accessibility data on PSMA PET/CT. PubMed/MEDLINE and major guideline sources were searched through August 2026 using terms related to prostate cancer, PSMA PET/CT, staging, biochemical recurrence, access, reimbursement, implementation, health equity, and cost-effectiveness. Priority was given to prospective trials, systematic reviews, guidelines, procedure standards, and recent European studies. Recommendations were cross-checked against the 2026 EAU Prostate Cancer Guidelines and EANM/SNMMI procedure guideline [4, 5]. Internal European accessibility modelling and Spanish physician market research were used to characterise implementation patterns rather than generate population-level estimates. Regulatory and reimbursement information was checked against official European and Spanish sources [7, 8]. Evidence selection and synthesis were narrative rather than systematic.

Why access to PSMA PET/CT matters

Initial staging

The strongest prospective evidence for primary staging comes from proPSMA, which showed greater accuracy of PSMA PET/CT than CT and bone scintigraphy for pelvic nodal and distant metastatic disease in high-risk prostate cancer before curative-intent treatment [1]. The phase II DEPROMP trial showed that upfront PSMA PET/CT can influence local treatment planning, lymph-node management, radiotherapy volumes, and metastasis-directed approaches [9]. A multidisciplinary Delphi study also reported treatment intensification after molecular upstaging and de-intensification in some downstaged patients [10]. A 2025 review concluded that PSMA PET improves disease characterisation while noting that prospective survival evidence remains lacking and treatment after stage migration requires caution [11].

These findings support timely access because staging accuracy influences treatment allocation. However, improved detection should not automatically be equated with better oncological outcomes. PSMA PET/CT can cause stage migration, and management of disease identified only by molecular imaging remains incompletely established [4]. Access policies should therefore evolve alongside evidence defining how PET findings should alter treatment.

Biochemical recurrence

PSMA PET/CT is particularly valuable in biochemical recurrence because disease can be detected at low PSA concentrations. A 2025 systematic review and meta-analysis reported positivity rates of approximately 48% at PSA 0.2–0.5 ng/mL and > 90% above 2 ng/mL [2]. In a 2025 multicentre analysis of patients with PSA ≤ 0.2 ng/mL, detection was approximately 30% [3].

Earlier localisation can distinguish local, nodal, and distant relapse and alter salvage planning. However, detection alone does not prove clinical benefit; value depends on whether findings lead to evidence-supported management changes. The EAU guideline recognises that PSMA PET/CT can change treatment intent, while direct evidence of improved oncological outcomes remains limited [4]. The most defensible consequence of delayed access is therefore delayed or less precise localisation and treatment planning rather than proven loss of survival benefit.

Guideline positioning

The 2026 EAU guideline recommends PSMA PET/CT, when available, to improve staging accuracy in unfavourable intermediate-risk disease and for metastatic screening in high-risk or locally advanced disease [4]. After radical prostatectomy, it is recommended for PSA recurrence when PSA is > 0.2 ng/mL if the result is expected to influence treatment; after radiotherapy, it is recommended in patients suitable for curative salvage treatment [4]. The EANM/SNMMI guideline provides complementary standards for acquisition, interpretation, and reporting [5]. The implementation question is therefore whether eligible patients can access PSMA PET/CT consistently and in time to inform care.

Current access: European signals and illustrative country experience

Spain and France were selected as illustrative country case studies because country-specific accessibility and implementation information was available for both settings, allowing examination of how reimbursement, healthcare organisation, referral pathways, and imaging capacity may influence access within different European contexts. These countries are not intended to represent the full diversity of European healthcare systems; rather, they provide complementary examples to illustrate implementation challenges identified at the European level.

Exploratory European accessibility estimates

An internal European accessibility model presented at an expert working meeting in 2026 suggested that real-world use remains below the estimated eligible population in several settings. Approximately two in five estimated eligible patients in initial staging and three in five in biochemical recurrence were estimated to receive PSMA PET/CT. These exploratory, industry-supported estimates are not population-based epidemiological data; their main value is to identify potential implementation gaps requiring independent validation.

Spain

Spain illustrates the distinction between national reimbursement and local implementation. Public financing of piflufolastat (18 F) (Pylclari) entered the Spanish National Health System nomenclátor on 1 July 2024, including funded indications for primary staging of high-risk prostate cancer before curative-intent treatment and localisation of recurrence after curative treatment [7]. European regulatory information confirms the core diagnostic indications [8].

Physician market research in Spain involving 20 specialists in prostate cancer care suggested substantial variation in PSMA PET/CT use across clinical scenarios, hospitals, and referral pathways. Approximately half of eligible patients undergoing initial staging and roughly three in five with biochemical recurrence were estimated to receive PSMA PET/CT. These are physician-derived implementation estimates, not audited national utilisation rates, and should not be interpreted as precise epidemiological measures.

Some tertiary centres have incorporated PSMA PET/CT into routine staging and recurrence pathways, whereas others rely on conventional imaging, require multidisciplinary approval, or refer patients externally. Regional budgets, PET/CT capacity, radiopharmacy networks, waiting times, and local authorisation processes can therefore influence access despite national reimbursement.

France

France showed a different pattern in the same exploratory accessibility model, with estimated access of approximately one in three eligible patients for initial staging and two in three for biochemical recurrence. These figures are signals of pathway heterogeneity rather than population-level estimates. The contrast suggests that tracer availability alone does not determine access; reimbursement, imaging capacity, referral pathways, and local implementation also matter.

Why access remains unequal

Reimbursement and approval

Reimbursement is a major determinant of implementation. Even when a PSMA tracer is authorised and nationally funded, access may depend on local formulary decisions, regional budgets, payer rules, or case-by-case approval. Mandatory sequential conventional imaging can add delay when not required by contemporary guidance. Clear indication-based reimbursement pathways are therefore needed to translate funding into clinical availability.

Nuclear medicine capacity and hospital organisation

PET/CT and reporting capacity, specialist staffing, and radiopharmacy services can limit throughput. Tertiary centres are more likely to have on-site nuclear medicine, multidisciplinary teams, and established referral pathways, whereas smaller hospitals may depend on external referral, adding administrative steps, travel, and waiting time. Such organisational differences may create inequity within the same healthcare system.

Radiopharmaceutical availability and logistics

Tracer availability has improved in many European settings, particularly with wider distribution of 18 F-labelled agents. Nevertheless, radiopharmacy access, production schedules, geographic distribution, radioactive half-lives, and contingency capacity can constrain scheduling. The EANM/SNMMI standard highlights the infrastructure and expertise required for safe, reproducible PSMA PET/CT [5].

Referral pathways, awareness, and multidisciplinary collaboration

Access can also be limited before the patient reaches nuclear medicine. Heterogeneous referral criteria, uncertainty about guideline indications, legacy preferences for conventional imaging, and variable multidisciplinary collaboration may influence whether PSMA PET/CT is requested. Standardised referral criteria and closer collaboration among urology, radiation oncology, medical oncology, radiology, and nuclear medicine can reduce unwarranted variation.

Healthcare financing model and geography

Barriers may differ across financing models: public systems may face budget, workforce, and capacity constraints, whereas private systems may introduce insurer authorisation or coverage requirements. Geography also matters because patients at centres without on-site PET/CT may face longer travel and referral times. Comparative evidence on public–private and urban–rural disparities remains limited and should be investigated rather than assumed. The overall ideal pathway and potential real-world bottlenecks are illustrated in Fig. 1.

Fig. 1.

Ideal access pathways and potential real-world bottlenecks. Conceptual illustration of ideal PSMA PET/CT pathways and potential access bottlenecks in initial staging and biochemical recurrence. Downstream clinical consequences shown in the figure are conceptual and should not be interpreted as proven causal effects of access delays

Potential clinical and health-system implications of limited access

Staging accuracy and treatment selection

The most direct implication of limited access is lower diagnostic sensitivity when less accurate alternatives are used. In higher-risk disease, this can alter nodal or metastatic classification and influence local treatment, lymph-node management, radiotherapy volumes, or systemic treatment intensification [1, 9, 10]. The magnitude of downstream benefit depends on evidence supporting management changes after molecular stage migration.

Recurrent disease and diagnostic delay

In biochemical recurrence, delayed PSMA PET/CT may postpone disease localisation and extend the diagnostic pathway, particularly when conventional imaging or choline PET/CT is required first. This can delay treatment planning. It remains important to distinguish effects on diagnostic timing and management intent from unproven claims regarding survival or loss of curative opportunity.

Equity, patient stratification, and access to innovation

Unequal access may create different diagnostic standards for clinically similar patients according to geography, institution, or payer pathway. PSMA-defined disease burden also informs multidisciplinary discussion, research eligibility, and, in selected advanced settings, assessment for PSMA-directed theranostic pathways [12]. Equity should therefore encompass availability, geography, reimbursement, timeliness, and appropriateness of use.

Health-economic considerations

Economic evaluation is central to the access debate. An analysis informed by proPSMA found PSMA PET/CT cost-effective versus conventional imaging in Australia, largely through improved diagnostic accuracy and avoidance of inaccurate staging pathways [13]. A later analysis using reimbursement data from Belgium, Germany, Italy, the Netherlands, and the United States found higher direct imaging costs in several settings, although incremental cost per accurate diagnosis remained relatively low compared with potential downstream costs of inaccurate staging [14].

Cost-effectiveness is context dependent. Assessment should include scan acquisition, conventional imaging avoided, repeat or sequential imaging, travel, waiting time, downstream procedures, treatment allocation, and consequences of inaccurate diagnosis. Local health-economic studies are therefore needed before extrapolating results between healthcare systems.

From evidence to implementation: priorities for action

Reducing unwarranted variation requires coordinated clinical, organisational, and policy action: (1) define guideline-based eligibility criteria for initial staging and biochemical recurrence; (2) harmonise reimbursement and avoid unsupported sequential imaging; (3) establish regional referral networks linking hospitals without on-site PET/CT to reference centres; (4) match scanner, radiopharmacy, reporting, and workforce capacity to demand; (5) strengthen multidisciplinary education and referral protocols; and (6) measure access using transparent quality indicators.

Proposed access indicators

The proposed indicators for assessing PSMA PET/CT access are summarised in Table 1.

Table 1.

Proposed indicators for assessing PSMA PET/CT access

Domain	Proposed indicator	Rationale
Coverage	Proportion of guideline-eligible patients receiving PSMA PET/CT	Measures implementation against clinical need
Timeliness	Median days from request to scan and from scan to validated report	Captures delay that can affect decision-making
Geographic equity	Travel time/distance and access by region	Identifies territorial disparities
Pathway efficiency	Proportion requiring conventional imaging before PSMA PET/CT	Identifies potentially avoidable sequential imaging
Capacity	PSMA PET/CT examinations per 100,000 population and per PET/CT scanner	Links demand to infrastructure
Referral	Proportion of eligible patients referred from centres without on-site PET/CT	Assesses effectiveness of referral networks
Reliability	Cancelled or postponed scans attributable to tracer or capacity constraints	Measures operational resilience
Clinical integration	Proportion of examinations performed within a defined multidisciplinary pathway	Assesses integration into prostate cancer care

Key evidence and access gaps relevant to PSMA PET/CT implementation are summarised in Table 2.

Table 2.

Evidence and access gaps relevant to PSMA PET/CT implementation

Evidence domain	Key finding	Relevance to access	Source
Initial staging	PSMA PET/CT accuracy 92% vs. 65% for conventional imaging in high-risk prostate cancer.	Patients without access may undergo less accurate staging before curative-intent treatment.	[1,7,8]
Biochemical recurrence	Positivity increases with PSA; approximately 48% at PSA 0.2–0.5 ng/mL and > 90% above 2 ng/mL in a 2025 meta-analysis.	Delayed access can postpone localisation and treatment planning.	[2]
Very low PSA recurrence	Detection remains possible at PSA ≤ 0.2 ng/mL; approximately 30% in one multicentre analysis.	Supports timely referral when results would influence management.	[3]
Guidelines	EAU 2026 incorporates PSMA PET/CT into higher-risk staging and biochemical-recurrence pathways.	Defines a guideline-eligible population against which access can be assessed.	[4,5]
European implementation	Exploratory modelling suggests use remains below the estimated eligible population.	Signals an implementation gap requiring independent validation.	Internal European accessibility model
Spain	National funding coexists with local variation in pathway adoption and capacity.	Illustrates that reimbursement alone does not guarantee timely access.	Spanish physician market research; [12,13]
Health economics	Cost-effectiveness varies across health systems and depends on downstream pathways.	Supports country-specific economic and capacity planning.	[10,11]

A regional or national PSMA PET access dashboard based on these indicators would help distinguish evidence gaps from implementation gaps and identify where capacity or pathway redesign is needed.

Limitations of the available access evidence

The evidence base for unequal access is less mature than that for diagnostic performance. Independently audited population-level utilisation data remain sparse, and several estimates derive from internal accessibility modelling and physician market research. These data are useful for identifying bottlenecks but are vulnerable to selection and recall bias and uncertainty in the eligible denominator. Country comparisons should therefore be interpreted cautiously. Future studies should link registry, claims, referral, and scanner-level data to guideline-defined eligibility and report geographic, institutional, socioeconomic, and waiting-time dimensions of access.

Conclusions

PSMA PET/CT is an important component of contemporary prostate cancer imaging, particularly for higher-risk staging and localisation of biochemical recurrence. However, timely access remains heterogeneous across countries, regions, and institutions. Barriers increasingly extend beyond tracer availability to reimbursement, nuclear medicine capacity, local protocols, referral pathways, and organisational factors.

Reducing unwarranted variation requires more than expanding tracer supply. Guideline-based eligibility, harmonised reimbursement, standardised referral pathways, adequate imaging and reporting capacity, and measurable access indicators are needed to deliver clinically appropriate PSMA PET/CT in a timely and equitable manner. Future research should determine whether improved access translates into more efficient diagnostic pathways, better treatment allocation, and improved patient outcomes.

Author contributions

J.G.R. developed the project and performed the literature review; L.F.H., L.T., A.P. and M.R. contributed to project development, interpretation of the evidence, and critical revision of the manuscript; J.G.R. drafted the manuscript; all authors critically revised the manuscript and approved the final version.

Funding

This work received no external funding.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Conflict of interest

The authors have no competing interests to declare that are relevant to the content of this article.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

AI-assisted language editing

During the preparation of this manuscript, an artificial intelligence-based tool (ChatGPT, OpenAI) was used to assist with language editing, clarity, and formatting. The authors reviewed and verified all AI-assisted modifications and remain fully responsible for the content, scientific accuracy, interpretation, and conclusions of the manuscript.