EUROPEAN UROLOGY xxx (xxxx) xxx–xxx

available at www.sciencedirect.com
journal homepage: www.europeanurology.com

Platinum Priority – Prostate Cancer

Editorial by XXX on pp. x-y of this issue

European Association of Nuclear Medicine Focus 5: Consensus on

Molecular Imaging and Theranostics in Prostate Cancer

Daniela-Elena Oprea-Lager a,*, Steven MacLennan b, Anders Bjartell c,d, Alberto Briganti e,
Irene A. Burger f, Igle de Jong g, Maria De Santis h,i, Uta Eberlein j, Louise Emmett k, Karim Fizazi l,
Silke Gillessen m,n, Ken Herrmann o, Sandra Heskamp p, Andrei Iagaru q,
Barbara Alicja Jereczek-Fossa r,s, Jolanta Kunikowska t, Marnix Lam u, Cristina Nanni v,
Joe M. O’Sullivan w,x, Valeria Panebianco y, Evis Sala z, Mike Sathekge aa,bb, Roman Sosnowski cc,
Derya Tilki dd,ee,ff, Bertrand Tombal gg, Giorgio Treglia hh,ii,jj, Nina Tunariu kk, Jochen Walz ll,
Derya Yakar mm,nn, Rudi Dierckx oo, Oliver Sartor pp, Stefano Fanti qq
a
Department of Radiology and Nuclear Medicine, Amsterdam UMC, Amsterdam, The Netherlands; b Academic Urology Unit, Institute of Applied Health
Sciences, University of Aberdeen, Aberdeen, UK; c Department of Translational Medicine, Medical Faculty, Lund University, Lund, Sweden; d Department of
Urology, Skåne University Hospital, Skåne, Sweden; e Department of Urology, Vita e Salute San Raffaele University, Milan, Italy; f Nuclear Medicine Department,
Kantonspital Baden, Baden, Switzerland; g Department of Urology, University Medical Center Groningen, Groningen, The Netherlands; h Department of Urology,
Charité Universitätsmedizin Berlin, Berlin, Germany; i Department of Urology, Medical University of Vienna, Vienna, Austria; j Department of Nuclear Medicine,
University Hospital Würzburg, Würzburg, Germany; k Theranostics and Nuclear Medicine Department, St Vincent’s Hospital Sydney, Sydney, Australia;
l
Department of Cancer Medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France; m Oncology Institute of Southern Switzerland (IOSI),
Bellinzona, Switzerland; n Department of Medical Oncology, Università della Svizzera Italiana, Lugano, Switzerland; o Department of Nuclear Medicine,
University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, Essen, Germany; p Department of Medical Imaging—Nuclear
Medicine Radboudumc, Nijmegen, The Netherlands; q Division of Nuclear Medicine and Molecular Imaging, Stanford University Medical Center, Stanford, CA,
USA; r Department of Oncology and Hemato-oncology, University of Milan, Milan, Italy; s Department of Radiation Oncology, IEO European Institute of
Oncology IRCCS, Milan, Italy; t Nuclear Medicine Department, Medical University of Warsaw, Warsaw, Poland; u Department of Radiology and Nuclear
Medicine, University Medical Center Utrecht, Utrecht, The Netherlands; v Nuclear Medicine Unit, IRCCS Azienda Ospitaliero-Universitaria di Bologna, Bologna,
Italy; w Patrick G Johnston Centre for Cancer Research, Queen’s University Belfast, Belfast, UK; x Northern Ireland Cancer Centre, Belfast, UK; y Department of
Radiological Sciences, Oncology and Pathology, Sapienza University of Rome, Rome, Italy; z Department of Radiology, Università Cattolica del Sacro Cuore and
Advanced Radiology Center, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; aa Nuclear Medicine Department, University of Pretoria,
Pretoria, South Africa; bb Nuclear Medicine Department, Steve Biko Academic Hospital, Pretoria, South Africa; cc Department of Urooncology, Maria
Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland; dd Martini-Klinik Prostate Cancer Center, University Hospital Hamburg-Eppendorf,
Hamburg, Germany; ee Department of Urology, University Hospital Hamburg-Eppendorf, Hamburg, Germany; ff Department of Urology, Koc University
Hospital, Istanbul, Turkey; gg Department of Surgery, Cliniques Universitaires Saint Luc, Brussels, Belgium; hh Clinic of Nuclear Medicine, Imaging Institute of
Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland; ii Faculty of Biomedical Sciences, Università della Svizzera italiana, Lugano,
Switzerland; jj Faculty of Biology and Medicine, University of Lausanne, Lausanne, Switzerland; kk Clinical Radiology, Drug Development Unit and Prostate
Cancer Targeted Therapy Clinical Trials, Royal Marsden Hospital, London, UK; ll Department of Urology, Institut Paoli-Calmettes Cancer Centre, Marseille,
France; mm Department of Radiology, University Medical Center of Groningen, Groningen, The Netherlands; nn Department of Radiology, Netherlands Cancer
Institute, Amsterdam, The Netherlands; oo Department of Nuclear Medicine and Molecular Imaging, University Medical Centre Groningen, Groningen, The
Netherlands; pp Departments of Medicine and Urology, Tulane University School of Medicine, New Orleans, LA, USA; qq Nuclear Medicine Division, Azienda
Ospedaliero-Universitaria di Bologna, Policlinico S.Orsola, Bologna, Italy

* Corresponding author. Department of Radiology and Nuclear Medicine, Amsterdam UMC,

Amsterdam, The Netherlands. Tel. + 31 020 444 4366.
E-mail address: [email protected] (D.-E. Oprea-Lager).

https://doi.org/10.1016/j.eururo.2023.09.003
0302-2838/Ó 2023 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article
under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
2 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX

Article info Abstract

Article history: Background: In prostate cancer (PCa), questions remain on indications for prostate-
Accepted September 4, 2023 specific membrane antigen (PSMA) positron emission tomography (PET) imaging and
PSMA radioligand therapy, integration of advanced imaging in nomogram-based
Associate Editor: decision-making, dosimetry, and development of new theranostic applications.
Giacomo Novara Objective: We aimed to critically review developments in molecular hybrid imaging and
systemic radioligand therapy, to reach a multidisciplinary consensus on the current state
Keywords: of the art in PCa.
Prostate cancer Design, setting, and participants: The results of a systematic literature search informed a
Theranostics two-round Delphi process with a panel of 28 PCa experts in medical or radiation oncol-
Nuclear medicine ogy, urology, radiology, medical physics, and nuclear medicine. The results were dis-
Molecular hybrid imaging cussed and ratified in a consensus meeting.
Systemic radioligand therapy Outcome measurements and statistical analysis: Forty-eight statements were scored on a
Likert agreement scale and six as ranking options. Agreement statements were analysed
using the RAND appropriateness method. Ranking statements were analysed using
weighted summed scores.
Results and limitations: After two Delphi rounds, there was consensus on 42/48 (87.5%)
of the statements. The expert panel recommends PSMA PET to be used for staging the
majority of patients with unfavourable intermediate and high risk, and for restaging of
suspected recurrent PCa. There was consensus that oligometastatic disease should be
defined as up to five metastases, even using advanced imaging modalities. The group
agreed that [177Lu]Lu-PSMA should not be administered only after progression to cabaz-
itaxel and that [223Ra]RaCl2 remains a valid therapeutic option in bone-only metastatic
castration-resistant PCa. Uncertainty remains on various topics, including the need for
concordant findings on both [18F]FDG and PSMA PET prior to [177Lu]Lu-PSMA therapy.
Conclusions: There was a high proportion of agreement among a panel of experts on the
use of molecular imaging and theranostics in PCa. Although consensus statements can-
not replace high-certainty evidence, these can aid in the interpretation and dissemina-
tion of best practice from centres of excellence to the wider clinical community.
Patient summary: There are situations when dealing with prostate cancer (PCa) where
both the doctors who diagnose and track the disease development and response to treat-
ment, and those who give treatments are unsure about what the best course of action is.
Examples include what methods they should use to obtain images of the cancer and
what to do when the cancer has returned or spread. We reviewed published research
studies and provided a summary to a panel of experts in imaging and treating PCa.
We also used the research summary to develop a questionnaire whereby we asked the
experts to state whether or not they agreed with a list of statements. We used these
results to provide guidance to other health care professionals on how best to image
men with PCa and what treatments to give, when, and in what order, based on the infor-
mation the images provide.
Ó 2023 The Author(s). Published by Elsevier B.V. on behalf of European Association of
Urology. This is an open access article under the CC BY license (http://creativecommons.
org/licenses/by/4.0/).

1. Introduction care professionals during initial staging and restaging of

PCa. The role of theranostic applications is currently recog-
Globally, prostate cancer (PCa) is the second commonest nised for the advanced metastatic castration-resistant PCa
male cancer [1,2]. Incidence rates are affected by prostate- (mCRPC), while potential indications for hormone-
specific antigen (PSA) testing availability, ageing popula- sensitive PCa are increasingly investigated. There are multi-
tions, genetic, lifestyle factors, and varying (inter)national ple uncertainties in the selection of radiopharmaceuticals,
guidance on screening and diagnosis [3,4]. indications for radioligand therapy, dosimetry, clinical trial
Modern imaging including the rapidly evolving PCa- design in theranostics, and clinical implementation of new
dedicated positron emission tomography (PET) tracers, radioisotopes. Therefore, to consolidate and disseminate
multiparametric magnetic resonance imaging (mpMRI) of best clinical practice and judicious use of resources, the
the prostate, and whole-body magnetic resonance imaging European Association of Nuclear Medicine (EANM) initiated
(MRI) with diffusion-weighted imaging (DWI) are existing the Focus 1 meeting dedicated to molecular imaging and
management paradigms, traditionally based on conven- theranostics in PCa, published in 2018 [5]. Five years later,
tional techniques. The concurrent use of these modalities to keep step with this rapidly evolving field, further consen-
in current practice creates a complex situation for health sus is required.

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX 3

1.1. Aim Table 1 – Expert panel field of expertise and country of practice

Name Expertise Country of

We aimed to define the role of advanced imaging tech-
practice
niques (ie, hybrid functional and anatomic PET/computed
Daniela-Elena Oprea- Nuclear medicine The Netherlands
tomography [CT]/MRI, PET-CT/PET-MRI imaging, and Lager
whole-body MRI with DWI) in PCa diagnosis and therapy Stefano Fanti Nuclear medicine Italy
beyond existing guidelines, as well as to define knowledge Barbara Alicja Radiation oncology Italy
Jereczek-Fossa
gaps for future studies. Anders Bjartell Urology Sweden
Within this overarching aim, we had a number of sub- Alberto Briganti Urology Italy
aims organised in five thematic tracks: (1) imaging in Irene A. Burger Nuclear medicine, Switzerland
Radiology
intermediate- and high-risk PCa (histopathology proven), Igle de Jong Urology The Netherlands
(2) imaging for biochemical recurrence of PCa, (3) imaging Maria De Santis Medical oncology Germany
of advanced PCa, (4) therapy of advanced PCa, and (5) Rudi Dierckx Nuclear medicine The Netherlands
Uta Eberlein Medical physics, nuclear Germany
important factors to consider in PCa consensus statement medicine
projects. The aims of each track can be reviewed in the Sup- Louise Emmett Nuclear medicine Australia
plementary material. Karim Fizazi Medical oncology France
Silke Gillessen Medical oncology Switzerland
Ken Herrmann Nuclear medicine Germany
Andrei Iagaru Nuclear medicine USA
2. Materials and methods Jolanta Kunikowska Nuclear medicine Poland
Marnix Lam Nuclear medicine The Netherlands
Joe M. O’Sullivan Clinical oncology UK
We used a robust and transparent methodology to assess Valeria Panebianco Radiology Italy
consensus within a multidisciplinary panel of experts and Evis Sala Radiology Italy
Oliver Sartor Oncology USA
multiple research methods to meet our aims. First, we sys-
Mike Sathekge Nuclear medicine South Africa
tematically searched the literature, guided by our thematic Roman Sosnowski Urology Poland
tracks, and appraised the quality of the evidence (see the Derya Tilki Urology Germany
Bertrand Tombal Urology Belgium
Supplementary material). Based on this review, the Focus
Nina Tunariu Radiology UK
5 meeting co-chairs and scientific programme advisor (D. Jochen Walz Urology France
O.L., R.D., and S.F.) created a list of statements that could Derya Yakar Radiology The Netherlands
be agreed or disagreed with, and for which the current evi-
dence base provides no clear answers. We included these
statements in a two-round modified Delphi process,
whereby an expert panel members were asked to state their available to the expert panelists alongside tables summaris-
strength of agreement with each statement. Finally, we dis- ing the quality assessment.
cussed these statements, exploring in detail the ones for
which there was no consensus, at a face-to-face consensus 2.2. Modified Delphi process
meeting in Seville, Spain, on February 2–4, 2023.
The participants in the Delphi process comprised experts In round 1 of the modified Delphi process, participants were
covering much of the spectrum of diagnostics and manage- e-mailed a link to an online survey containing 44 agreement
ment of PCa, including molecular imaging and radionuclide statements and six ranking questions organised in five the-
therapy specialists, radiologists, medical oncologists, radia- matic tracks (see the Supplementary material for the full
tion oncologists, and urologists. Experts were identified via questionnaire). For the 44 agreement statements, panelists
authorship of published research on PCa. Twenty-nine were asked to state their strength of agreement with each
experts were invited to participate; one declined because statement on a 9-point Likert scale (1, strongly disagree;
of the feeling that the expertise was scientific rather than 5, neither agree nor disagree; and 9, strongly agree). Pane-
clinical. The remaining 28 completed both rounds. Their lists were urged only to choose five if they felt that they
areas of expertise and country of practice can be seen in truly neither agreed nor disagreed and to utilise the ‘‘unable
Table 1. to score’’ option if they did not have enough expertise to
answer. For the ranking questions, participants were asked
to rank their preferences in order or abstain if they felt that
2.1. Systematic literature search
they did not have enough expertise to answer.
The PubMed database was searched from January 1, 2020 to Participants could comment on any statement in round 1
August 10, 2022 for English-language publications regard- and propose statements for consideration by the scientific
ing molecular imaging and therapy of PCa. Systematic committee that they believed should be added for round 2
reviews, meta-analyses, evidence-based guidelines, and scoring. Four agreement statements were added based on
consensus statements were included. Given that the area the panelists’ suggestions, giving 48 agreement statements
is evolving rapidly, review papers prior to 2020 were con- in total, and two questions were reworded for clarification
sidered to be outdated and therefore were not used. (these are clearly flagged in the results tables).
The quality of the retrieved systematic reviews was In round 2 of the modified Delphi process, participants
assessed using the AMSTAR 2 criteria (full search strategy were reminded of their own round 1 scores for every ques-
and results are shown in the Supplementary material) [6]. tion and shown the bar charts of the distribution of other
The papers retrieved in the literature search were made panelists’ scores for each agreement statement, as well as

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
4 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX

the bar charts for the ranking preference questions. They before 2020, and one was not in English). Sixty-four recent
were asked to rescore the original items and score the systematic reviews or meta-analyses and seven consensus
reworded and new items. REDCap was used to collect data statements or guidelines were included and provided to
and manage all aspects of the Delphi process [7,8]. the panellists. In each track, there were systematic reviews
rated at low, moderate, and high quality, with no dis-
2.3. Outcome measures and statistical analysis—Delphi cernible difference in quality between tracks.

For the 48 agreement statements, the Research and Devel-

opment Corporation (RAND) ‘‘appropriateness method’’ 3.2. Delphi
was followed [9]. For each statement, the median score
and 30–70th interpercentile range (IPR) were calculated. In round 1, there was consensus on 39/44 (88.8%) of the
Then, the IPR adjusted for symmetry (IPRAS) was calculated, statements. After two Delphi rounds, there was consensus
using the following formula: (IPRAS = 2.35 + [asymmetry on 42/48 (87.5%) of the statements. The median number
index  1.5]). Asymmetry is the absolute difference of panelists choosing unable to score was 2 in both rounds
between the central point of the IPR and 5 (ie, the scale cen- (range 1–11 in round 1 and 0–14 in round 2). The results
tre point). If IPR is < IPRAS, this is interpreted as the range of for the agreement statements after two rounds are tabu-
scoring being narrowly dispersed around the median score lated below, split by track, and the results of ranking state-
and is defined as ‘‘consensus’’. Median scores in the range ments are shown in bar charts. The full results of both
of 1–3 were categorised as ‘‘disagree’’, 4–6 as ‘‘uncertain’’, Delphi rounds can be viewed in the Supplementary
and 7–9 as ‘‘‘agree’’. A worked example is shown in the Sup- material.
plementary material. The number choosing ‘‘unable to The terms PSMA PET-CT and PET-MRI are ‘‘generically’’
score’’ was noted for each statement. A calculator in Micro- used in this paper, irrespective of the type of isotope or
soft Excel [10] was created and used for all consensus ligand used.
analyses. In track 1, there was consensus for all 15 statements (see
For the six ranking statements, weighted scores were Table 2), indicating the scope and general agreement that
used to summarise the group preferences. The number of mpMRI and PSMA PET-CT/PET-MRI have a clear role in ini-
instances of each rank was calculated (eg, 1–5 on a question tial staging and incorporation into nomograms for unfa-
with five choices to rank), then the highest scoring choice vourable intermediate- and high-risk PCa, even though the
was allocated the highest weight and the lowest given the impact of imaging on patient management and survival out-
lowest weighting. Each choice was then multiplied by the comes is currently unknown.
weighting, and the results were summed and then sum- For both ranking questions in track 1, PSMA PET-CT/PET-
marised in bar charts. MRI was found to be the preferred imaging modality to
assess nodal (Fig. 1) and distant metastases at initial diag-
2.4. Consensus meeting
nosis of high-risk PCa (Fig. 2). The panel agreed unani-
mously that PSMA PET-CT should replace conventional
A face-to-face consensus meeting was held on February 2– imaging in patients with high-risk PCa undergoing initial
4, 2023, in Seville, Spain. Thematic sessions were organised staging.
corresponding to the five tracks. In each session, up to eight In track 2 (see the results in Table 3 and Fig. 3), there was
presentations were given by different members of the consensus on ten of 14 (71%) statements. Panelists shared
expert panel, depending on their expertise. These were the view that mpMRI should not be the preferred choice
organised to provide expert interpretation in favour of or of biochemical recurrence imaging, even at low PSA levels,
against the issues being discussed, and an overview of the and agreed that there is a clear preference for PSMA PET-
evidence base. At the end of each track session, there was CT/PET-MRI for recurrence imaging, depending on various
a question and answer session, chaired by the Focus 5 co- PSA-based scenarios. No consensus was reached on whether
chair (D.O.L.) and different panel experts (S.F., A.I., J.O’S., S. mpMRI should be performed in patients with a suspicion of
G., A.B., and J.K.). This meeting provided an opportunity local recurrent disease, regardless of the PSA level.
for the panel to explore the statements for which there In track 3 (see Table 4), there was consensus for all ques-
was no consensus and to provide explanation and nuance tions. Taken together, these statements indicate that there
for all statements. Importantly, there was no aim for the is a role for advanced imaging modalities in categorising
discussion to over-ride the Delphi results. The programme and managing patients with metastatic castration-
can be reviewed online at https://focusmeeting.eanm.org/ sensitive PCa, non-mCRPC (M0 CRPC), and oligo- or poly-
programme/. metastases. There was consensus on defining oligometa-
static disease as five or fewer metastases, even using
3. Results advanced imaging modalities.
In track 4, there was consensus on 14/16 (88%) agree-
ment statements in favour of [177Lu]Lu-PSMA, not only in
3.1. Systematic literature search
terms of administration, maximum activity, and optimal
The complete results of the systematic literature search and number of cycles to be offered, but also regarding retreat-
AMSTAR2 results are reported in the Supplementary mate- ment, bone marrow involvement, and extent of disease to
rial. Briefly, among 126 records retrieved, 62 were excluded be treated (Table 5, and Figs. 4 and 5). The group agreed that
(35 were not in the field of interest, 26 were published [177Lu]Lu-PSMA should not be administered only after pro-

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX 5

Table 2 – Delphi results after two rounds of scoring for track 1: imaging in intermediate- and high-risk PCa (histopathology proven)

Mediana 30th 70th Consensus Unable

Pcentile Pcentile to score
1.1. mpMRI of the prostate is recommended for patients with a clinical suspicion of prostate 9 9 9 Yes 2
cancer (ie, mpMRI in first detection setting).
1.2. mpMRI of the prostate is the most useful imaging method for local staging of intermediate- 9 9 9 Yes 2
and high-risk prostate cancer.
1.3. PSMA PET-CT/PET-MRI for staging should be performed only after mpMRI of prostate and 9 8 9 Yes 1
targeted biopsy.
1.4. PSMA PET-CT/PET-MRI should be used for staging of the majority of patients with favourable 1 1 3 Yes 1
intermediate-risk prostate cancer.
1.5. PSMA PET-CT/PET-MRI should be used for staging of the majority of patients with 8 8 9 Yes 1
unfavourable intermediate-risk prostate cancer (ie, primary Gleason pattern of 4, 50%
percentage of prostate biopsy cores, or 2 NCCN intermediate-risk factors: clinical stage T2b
or T2c, total Gleason score = 7 or PSA level = 10–20 ng/ml).
1.7. Modern nomograms, which incorporate PSMA PET-CT findings together with mpMRI 9 8 9 Yes 1
findings and MRI-targeted biopsy, should be used to identify candidates for extended lymph
node dissection (ie, dissection of presacral, obturator, external, internal, and common iliac
nodes) at the time of radical prostatectomy, as opposed to classic nomograms using only
clinical and biopsy findings (on random TRUS).
1.8. PSMA PET-CT/PET-MRI (skull base to midthigh) is preferred to pelvic or whole-body MRI for 9 9 9 Yes 1
the detection of locoregional (N1) and distant (M1a) lymph node metastases in intermediate-
and high-risk prostate cancer.
1.9. PSMA PET-CT should replace both bone scan and abdominopelvic CT in patients with high- 9 9 9 Yes 1
risk prostate cancer, undergoing initial staging.
1.10. Choline PET-CT/PET-MRI is preferred to bone scan for staging of primary prostate cancer, 8 7 9 Yes 1
when staging is indicated.
1.12. mpMRI of the prostate is useful for local treatment planning (eg, targeted biopsy, tumour 9 9 9 Yes 1
delineation) in patients with intermediate- to high-risk prostate cancer.
1.13. Availability of 68Ga/18F-PSMA PET-CT is often limited to some nuclear medicine centres. 1 1 2 Yes 4
Given that 99mTc-PSMA-SPECT-CT could be widely available, 99mTc-PSMA-SPECT-CT should be
preferred to PSMA PET-CT.
1.14. 99mTc-MDP-SPECT bone scan and 99mTc-PSMA-SPECT scan share similar procedures and 8 7 9 Yes 7
radiation exposures. 99mTc-PSMA-SPECT scan should replace 99mTc-MDP-SPECT bone scan.
1.15. Patients with distant metastases at diagnosis, detectable only with advanced imaging 7.5 7 8 Yes 2
techniques (eg, PSMA PET-CT/PET-MRI or whole-body MRI), should be offered definitive local
therapy along with metastasis-directed therapies, even though the impact of these techniques
for prognosis and optimal patient management is unknown.
CT = computed tomography; mpMRI = multiparametric magnetic resonance imaging; MRI = magnetic resonance imaging; NCCN = National Comprehensive
Cancer Network; PCa = prostate cancer; Pcentile = percentile; PET = positron emission tomography; PSA = prostate-specific antigen; PSMA = prostate-specific
membrane antigen; SPECT = single-photon emission computed tomography; TRUS = transrectal ultrasound.
a
1–3 = disagree; 4–6 = uncertain; 7–9 = agree.

(round 2)

Fig. 1 – Group preferences for question 1.6: please rank the following methods to assess nodal metastases at initial diagnosis of high-risk prostate cancer, with
1 being your top preference, 2 your second, and so on. CT = computed tomography; MRI = magnetic resonance imaging; PET = positron emission tomography;
PSMA = prostate-specific membrane antigen.

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
6 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX

Grouped preferences for queson 1.11 (round 2)

Fig. 2 – Group preferences for question 1.11: please rank the following methods to assess distant metastases at initial diagnosis of prostate cancer, with 1
being your top preference, 2 your second, and so on. CT = computed tomography; MRI = magnetic resonance imaging; PET = positron emission tomography;
PSMA = prostate-specific membrane antigen.

Table 3 – Delphi results after two rounds of scoring for track 2: imaging for biochemical recurrence of prostate cancer

Mediana 30th 70th Consensus Unable

Pcentile Pcentile to score
2.1. mpMRI of the prostate should be performed in patients with a suspicion of local recurrent 5 3 8 No 1
disease (regardless of the PSA level).
2.2 A PSMA PET-CT/PET-MRI scan should be performed if mpMRI of the prostate is negative for 9 9 9 Yes 1
recurrent prostate cancer.
2.3. mpMRI should not be used for local recurrences in the prostatic bed in patients with a low 8 7.8 9 Yes 1
PSA level (<0.5 ng/ml, after prostatectomy).
2.4. PSMA PET-CT/PET-MRI should be performed in the majority of patients with a suspicion of 9 9 9 Yes 1
recurrent prostate cancer.
New question 2.5a. A participant in round 1 commented that question 2.5 was unclear. Therefore, 8 3 8 No 1
the Focus 5 chairs added the precursor question 2.5a. Please score it on the 1–9 scale: PSMA
PET-CT/PET-MRI should always be performed as the only imaging modality in patients with
(any level of risk or PSA) a suspicion of recurrent prostate cancer.
2.5. PSMA PET-CT/PET-MRI should always be performed in adjunct to mpMRI of the prostate in 3 2 8 No 2
patients with (any level of risk or PSA) a suspicion of recurrent prostate cancer.
2.6. Choline PET-CT/PET-MRI is useful in biochemical recurrence setting after curative local 8 8 8 Yes 1
treatment (ie, surgery or radiotherapy) of prostate cancer, with rising PSA above 4 ng/ml.
2.7. [18F-]fluciclovine PET-CT/PET-MRI is the preferred imaging method for detecting metastases 2 1 3 Yes 3
in the setting of local relapse after radical prostatectomy. [18F-]fluciclovine is a radiolabelled
amino acid analogue that functions based on amino acid transport upregulation in prostate
cancer.
2.9. PSMA PET-CT/PET-MRI is the preferred imaging method for the detection of recurrent disease 9 9 9 Yes 1
after radical prostatectomy, at PSA levels <0.5 ng/ml.
2.10. mpMRI of the prostate should be used for the detection of local recurrences after 5 2 6 No 3
radiotherapy, at low PSA levels of <0.5 ng/ml.b
2.11. PSMA PET/CT should be used for the detection of local recurrences after radiation therapy, 8 7 8 Yes 1
even at low PSA levels of <0.5 ng/ml.b
2.12. PSMA PET-CT/PET-MRI should be used to guide metastasis-directed therapy in patients 9 9 9 Yes 1
with oligometastases relapsing after a local treatment. Note: some wording has been clarified
in this question. Red text highlights the addition.
2.13. Men with persistent detectable PSA after radical prostatectomy (ie, PSA >0.1 ng/ml, >6 wk 9 9 9 Yes 1
after radical prostatectomy, irrespective of the surgical margin status) should be investigated
with PSMA PET-CT or PET-MRI.
2.14. [18F-]fluoride PET-CT/PET-MRI should be preferred to bone scan for the detection of bone 9 7 9 Yes 1
metastases at biochemical recurrence of prostate cancer.
CT = computed tomography; mpMRI = multiparametric magnetic resonance imaging; MRI = magnetic resonance imaging; Pcentile = percentile; PET = positron
emission tomography; PSA = prostate-specific antigen; PSMA = prostate-specific membrane antigen.
a
1–3 = disagree; 4–6 = uncertain; 7–9 = agree.
b
Please note that PSA levels of <0.5 ng/ml after radiotherapy are below the ASTRO Phoenix definition of biochemical recurrence.

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX 7

RI
yM
od
-b
le
ho
W

Fig. 3 – Group preference for question 2.8: please rank the following methods to assess recurrent prostate cancer, with 1 being your top preference, 2 your
second, and so on. CT = computed tomography; mpMRI = multiparametric magnetic resonance imaging; MRI = magnetic resonance imaging; PET = positron
emission tomography; PSMA = prostate-specific membrane antigen.

Table 4 – Delphi results after two rounds of scoring for track 3: imaging of advanced prostate cancer

Mediana 30th 70th Consensus Unable

Pcentile Pcentile to score
3.1. Advanced imaging modalities (ie, PSMA PET-CT/PET-MRI, whole-body MRI) can be used to 8 7 8.5 Yes 2
define high- and low-volume metastases (CHAARTED criteria) in metastatic hormone-
sensitive prostate cancer.
3.2. Management of patients with nonmetastatic castration-resistant prostate cancer (by 9 8 9 Yes 1
conventional imaging) is likely to be modified by advanced imaging techniques (eg, PSMA
PET-CT/PET-MRI or whole-body MRI).
3.3. Oligometastatic prostate cancer should be defined as 5 metastases (detected on advanced 9 8 9 Yes 1
imaging modalities, eg, PSMA PET-CT/PET-MRI or whole-body MRI).
3.4. PSMA PET-MRI is equivalent (in terms of diagnostic accuracy) to PET-CT, in the majority of 8 8 8 Yes 4
patients with metastatic advanced prostate cancer.
CT = computed tomography; MRI = magnetic resonance imaging; Pcentile = percentile; PET = positron emission tomography; PSMA = prostate-specific
membrane antigen.
a
1–3 = disagree; 4–6 = uncertain; 7–9 = agree.

gression to cabazitaxel and that [223Ra]RaCl2 remains a allows for the identification of knowledge gaps to inform
valid therapeutic option in bone-only mCRPC. There was future research. We controlled for group processes and
no consensus on the use of [177Lu]Lu-PSMA only in patients dominant voices through anonymised voting and controlled
with concordant findings on both [18F]FDG PET and PSMA feedback in the Delphi process. This provided a framework
PET, assuming that metastases show adequate PSMA for discussion at the face-to-face meeting, which offered
expression. some nuance and detail for interpreting the consensus
The expert panel agreed that patient advocates should be statements.
invited to review and comment on consensus statements A relatively large proportion of panelists chose unable to
(Table 6). score for some statements. However, this is somewhat
expected given wide-ranging disciplines from which we
drew our expert panel, so for some questions, highly spe-
3.3. Limitations cialised knowledge was required, and it was better for the
Expert consensus, based on low-certainty evidence, is still panelists to have the option to abstain rather than, for
low-certainty evidence [11]. Nonetheless, guidance is example, vote ‘‘5’’, potentially falsely skewing the median.
required, and where there is a diverse evidence base span- This study was conducted on behalf of the EANM, and
ning a number of disciplines and rapidly evolving field, util- the majority of panelists were from European centres,
ising the knowledge of a multidisciplinary group of experts although experts from the USA, Australia, and South Africa
is a sensible and efficient interim step. It also importantly were also invited and actively participated. It could be pro-

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
8 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX

Table 5 – Delphi results after two rounds of scoring for track 4: therapy of advanced prostate cancer

Mediana 30th 70th Consensus Unable

Pcentile Pcentile to score
4.1. [177Lu]Lu-PSMA can be administered at the outpatient clinic (if allowed by local regulators). 9 8 9 Yes 4
4.4. Retreatment with another 4–6 cycles of [177Lu]Lu-PSMA should be considered in patients 8 6.2 8 Yes 13
with disease recurrence who received 6 injections of [177Lu]Lu-PSMA (and had an initial good
response, eg, progression-free survival of at least 6 mo).
4.5. In bone-only mCRPC, [223Ra]RaCl2 remains a valid therapeutic option despite the availability 9 8 9 Yes 6
of [177Lu]Lu-PSMA.
4.6. In mCRPC, patients should receive [177Lu]Lu-PSMA only after progression to cabazitaxel. 1 1 1 Yes 5
4.7. [177Lu]Lu-PSMA should be used before PARP inhibitors in patients with mCRPC. Note: based 5 5 5 Yes 6
on the feedback from round 1 participants, we have added a clarification to question 4.7. The
amended wording is in red text. Please score this amended question: 4.7. [177Lu]Lu-PSMA
should be used before PARP inhibitors in patients with BRCA 1– or 2–associated mCRPC.
4.8. [177Lu]Lu-PSMA should be used only in patients with concordant findings on both [18F]FDG 6 3 6.7 No 6
PET and PSMA PET, assuming that metastases show adequate PSMA expression.
4.9. Patients with extensive bone metastases and bone marrow involvement are eligible for 9 8 9 Yes 5
[177Lu]Lu-PSMA therapy (assuming that the bone marrow function is adequate).
4.10. Patients with brain metastases are eligible for [177Lu]Lu-PSMA therapy. 8 8 8 Yes 10
4.11. Kidney dysfunction (GFR <45) is a contraindication for [177Lu]Lu-PSMA therapy. Note: based 3 3 6.2 No 11
on the feedback from round 1 participants, we have added a clarification to question 4.11. The
amended wording is in red text. Please score this amended question: 4.11. Kidney dysfunction
(GFR <45) is a relative contraindication for [177Lu]Lu-PSMA therapy.
4.12. WHO ECOG 3 patients can be considered for [177Lu]Lu-PSMA therapy. 7 6 8 Yes 7
4.13. [177Lu]Lu-PSMA-I&T and [177Lu]Lu-PSMA-617 have similar efficacy in the treatment of 8 7 8.1 Yes 14
mCRPC.
4.14. Therapy with [225Ac]Ac-PSMA (if available) should be considered as an alternative to [177Lu] 7 5 8 Yes 11
Lu-PSMA, in patients with mCRPC being [177Lu]Lu-PSMA naïve or progressing after [177Lu]Lu-
PSMA.
4.14a (new). Therapy with [225Ac]Ac-PSMA (if available) should be considered as an alternative to 8 7.1 8 Yes 10
[177Lu]Lu-PSMA, in patients with mCRPC progressing after [177Lu]Lu-PSMA. Note: based on
the feedback from participants in round 1, a new question related to question 4.14 has been
added. Please score this question on the same 1–9 scale.
4.15. In patients with metastatic advanced prostate cancer, the combinations of [177Lu]Lu-PSMA 8 6 8 Yes 4
with novel hormonal agents play a role outside of clinical trials. Note: in response to a
comment from a participant in round 1, some text has been amended to clarify the question.
The amended text is indicated in red.
New question 4.16. Administered activity in [177Lu]Lu-PSMA therapy should be based on 7 6 7 Yes 10
dosimetry.
New question 4.17. PSMA PET is mandatory before PSMA-targeted therapy. 9 9 9 Yes 1
ECOG = Eastern Cooperative Oncology Group; GFR glomerular filtration rate; mCRPC = metastatic castration-resistant prostate cancer; Pcentile = percentile;
PET = positron emission tomography; PSMA = prostate-specific membrane antigen; WHO = World Health Organization.
a
1–3 = disagree; 4–6 = uncertain; 7–9 = agree.

Fig. 4 – Group preferences for question 4.2: please rank the following options in order of the maximum activity of [177Lu]Lu-PSMA that you think can be
administered safely in mCRPC, with 1 being your top preference, 2 your second, and so on. mCRPC = metastatic castration-resistant prostate cancer;
PSMA = prostate-specific membrane antigen.

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX 9

Fig. 5 – Group preferences for question 4.3: please rank the following options in order of the maximum number of cycles of [177Lu]Lu-PSMA (7.4 GBq per cycle)
that you think can be administered safely and efficiently in mCRPC, with 1 being your top preference, 2 your second, and so on. mCRPC = metastatic
castration-resistant prostate cancer; PSMA = prostate-specific membrane antigen.

Table 6 – Delphi results after two rounds of scoring for track 5: important factors to consider in prostate cancer consensus statement projects

Mediana 30th 70th Consensus Unable

Pcentile Pcentile to score
5.1. Consensus statements agreed by clinical experts should be shared with patient advocates 9 9 9 Yes 0
who should be invited to review and comment on the statements.
Pcentile = percentile.
a
1–3 = disagree; 4–6 = uncertain; 7–9 = agree.

posed that the results are applicable mainly to Europe, but To situate our interpretation within the wider literature,
we encourage practitioners in other continents to assess and offer a transparent link between the specific studies
the applicability of the results in their area of expertise. that the statements drew upon, we have clarified the state-
ment numbers in brackets and signposted the relevant
citations.
4. Discussion
The panel agreed that mpMRI of the prostate is recom-
mended for patients with clinical suspicion of PCa (1.1)
Given the rapid progress in PCa management, guidelines on and is the most useful imaging method for local staging of
screening, diagnosis, and treatment of clinically localised, intermediate- and high-risk PCa (1.2) [16], aligning with
relapsing, metastatic, and castration-resistant PCa are the EAU guidelines [12].
revised yearly [12,13]. The Advanced PCa Consensus Confer- In concordance with a recent meta-analysis of 23 studies
ence is organised regularly to supplement evidence-based [17], the panel concurred that PSMA PET-CT/PET-MRI is use-
guidelines for key dilemmas in clinical management of ful for staging PCa after mpMRI and targeted biopsy (1.3) in
PCa [14,15]. The improvement of anatomicofunctional patients with unfavourable intermediate- (1.5) and high-
imaging modalities to (re)stage PCa and to characterise risk (1.8) PCa.
advanced disease, as well as the evolution of the theranos- All panelists agreed strongly in favour of replacing bone
tics field, continue to pose questions and deliver controver- scan and abdominopelvic CT with PSMA PET/CT scans, for
sies. Therefore, to reach a multidisciplinary consensus on staging patients with high-risk PCa (1.10), which makes
the current state of the art in PCa and to make expert rec- the results of a recent systematic review valid for use in
ommendations on how to advance the field towards estab- routine clinical practice [18] and aligns these with a recent
lishing clinical impact, a new EANM Focus 5 meeting in PCa Dutch consensus statement [19].
was organised. Broadly, there was consensus within the The panel agreed that [18F]fluciclovine PET-CT/PET-MRI
panel. Although there was a reduction in consensus is not the preferred imaging method for detecting metas-
between Delphi rounds 1 and 2, this is an artefact of new tases in the setting of local relapse after radical prostatec-
statements being added, rather than a reflection of reduced tomy (2.7). There is still room for choline PET-CT/PET-MRI
consensus in the group.

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
10 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX

[20], when PSMA either is not available or has limited avail- have been proposed for structured reporting of PSMA PET
ability, in case of PSMA-negative disease, in the biochemical and harmonisation of interpretation criteria, and are suc-
recurrence setting, or after curative local treatment of PCa, cessfully applied in clinical practice [34–37].
with PSA rising above 4 ng/ml (2.6) [12].
There is initial evidence that mpMRI using a standard-
ised scoring system, the Prostate Imaging for Recurrence 5. Conclusions
Reporting, can identify local recurrence accurately, but fur-
ther evidence is warranted [21]. There was consensus that We systematically searched the literature to inform a panel
PSMA PET-CT/PET-MRI should be used to guide of experts who participated in two modified Delphi rounds
metastasis-directed therapy in patients with oligometas- and a consensus meeting where consensus was sought and
tases relapsing after a local treatment (2.12) [22]. gained on several pressing issues, and knowledge gaps were
No consensus was reached on whether mpMRI should be identified. Consensus statements cannot replace high-
used for the detection of local recurrences after radiother- certainty evidence, but what we have provided here is an
apy, at low PSA values under 0.5 ng/ml (2.10). On the con- expert recommendation of best practice from centres of
trary, there was consensus on the use of PSMA PET-CT for excellence to guide the wider clinical community. These
detecting local recurrences after radiation therapy, even at consensus statements should also be used as a basis to
low PSA levels of <0.5 ng/ml (2.11). When these statements design prospective studies and clinical trials.
are considered against the current ASTRO Phoenix defini-
tion of biochemical recurrence after curative radiotherapy Author contributions: Daniela-Elena Oprea-Lager had full access to all
(which is defined as PSA nadir + 2 ng/ml) [23] and the the data in the study and takes responsibility for the integrity of the data
National Comprehensive Cancer Network 2023 guidelines, and the accuracy of the data analysis.
which accept restaging at PSA levels below 2 ng/ml only
in young patients with rapidly increasing PSA [24], there
Study concept and design: Oprea-Lager, MacLennan, Treglia, Dierckx, Fanti.
is a scope for refining currently used definitions.
Acquisition of data: MacLennan, Treglia.
The panel agreed that current management of patients Analysis and interpretation of data: Oprea-Lager, MacLennan, Treglia,
with non-mCRPC (by conventional imaging) is likely to be Dierckx, Fanti.
modified by advanced imaging techniques (eg, PSMA PET- Drafting of the manuscript: Oprea-Lager, MacLennan, Treglia, Fanti.
CT/PET-MRI or whole-body MRI; 3.2) [25,26]. Critical revision of the manuscript for important intellectual content: Oprea-
All panellists agreed that the maximum number of Lager, MacLennan, Bjartell, Briganti, Burger, de Jong, De Santis, Eberlein,
metastases detected on advanced imaging modalities is up Emmett, Fizazi, Gillessen, Herrmann, Heskamp, Iagaru, Jereczek-Fossa,
to 5. This is in line with other consensus statements show- Kunikowska, Lam, Nanni, O’Sullivan, Panebianco, Sala, Sathekge, Sos-
ing that the number of oligometastases diagnosed by PSMA nowski, Tilki, Tombal, Treglia, Tunariu, Walz, Yakar, Dierckx, Sartor,
PET/CT ranged between 3 and 5 [19]. Fanti.
However, the time of metastatic presentation and dis- Statistical analysis: MacLennan.
ease volume are proved to be prognostic for patients with Obtaining funding: Oprea-Lager, Dierckx, Fanti.
metastatic hormone-sensitive PCa treated with androgen Administrative, technical, or material support: Oprea-Lager, MacLennan,
deprivation therapy. This simple prognostic classification Dierckx, Fanti.
system can aid patient counselling and future trial design Supervision: Oprea-Lager, MacLennan, Dierckx, Fanti.
[27]. Other: None.

In patients with bone-only mCRPC, [223Ra]RaCl2 remains

a valid therapeutic option despite the availability of [177Lu] Financial disclosures: Daniela-Elena Oprea-Lager certifies that all con-
Lu-PSMA (4.5). There was consensus to disagree that flicts of interest, including specific financial interests and relationships
patients with mCRPC should receive [177Lu]Lu-PSMA only and affiliations relevant to the subject matter or materials discussed in
after progression to cabazitaxel (4.6) [28]. the manuscript (eg, employment/affiliation, grants or funding, consultan-
The panel agreed that in patients with metastatic cies, honoraria, stock ownership or options, expert testimony, royalties, or
advanced PCa, the combinations of [177Lu]Lu-PSMA with patents filed, received, or pending), are the following: Anders Bjartell: sci-
novel hormonal agents play a role outside of clinical trials entific advisory board of and/or speaker honoraria from AAA, Accord,
(4.15) [29–33]. Finally, there was consensus that the admin- Astellas, AstraZeneca, Bayer, Ferring, Ipsen, Janssen, MSD, Sandoz, and
istered activity in [177Lu]Lu-PSMA therapy should be based Telix; research grants from Astellas, Bayer, and Ferring; co-founder of
on dosimetry (4.16) and that PSMA PET is mandatory before Glactone Pharma AB; board member of Glactone Pharma AB and Noviga
PSMA-targeted therapy (4.17). AB; and shareholder of LIDDS AB, Glactone Pharma AB, WntResearch

An important point must be highlighted when referring AB, and Noviga AB. Alberto Briganti: Astellas Pharma Janssen-Cilag, OPKO
Health, MDx Health, Bayer, miR Scientific, LLC (‘‘miR’’), A3P Biomedical,
to PSMA PET in this consensus on molecular imaging and
MSD/AstraZeneca, Ferring, Pfizer, Sandoz-Novartis, and Telix Pharmaceu-
theranostics in PCa. The term ‘‘PSMA’’ was used generically,
ticals. Irene Burger: advisory role (compensated, institutional) at GE-
including all available types of 68Ga- or 18F-radiolabelled
Healthcare, AAA (Novartis), and Merck; research support (institutional)
PSMA PET tracers. This has consequences on the confidence
from GE-Healthcare and Bayer; travel support from GE-Healthcare and
grade on the reporting of findings, especially in light of
Bayer; and speakers’ bureau (compensated, institutional) of GE-
known nonspecific bone activity for some tracers (eg, 18F-
Healthcare, Bayer, Astellas, and Janssen. Igle de Jong: none. Maria De San-
PSMA-1007). Nevertheless, to reduce the number of false tis: personal financial interests: advisory function at and honoraria from
positive and/or inconclusive results, different guidelines AAA, Amgen, Astellas, AstraZeneca, Basilea, Bayer, Bioclin, BMS, EISAI, Fer-

Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
 EUROPEAN UROLOGY XXX (XXXX) XXX–XXX 11

ring, Immunomedics, Ipsen, Janssen, MSD, Merck, Novartis, Pfizer, Pierre ono, Foundation Medicine, Fusion, Genzyme, Hengrui, Isotopen Technolo-
Fabre Oncology, Roche, Sandoz, Sanofi, and SeaGen; institutional financial gien Meunchen, Merck, Janssen, Morphimmune, Myovant, Myriad, Noria
interests: honoraria and clinical trial fees from Amgen, Astellas, AstraZe- Therapeutics, Inc., NorthStar, Novartis, Noxopharm, Progenics, POINT Bio-
neca, Bayer, Bioclin, BMS, EISAI, ESSA, Ferring, Ipsen, Janssen, MSD, Merck, pharma, Pfizer, RATIO, Sanofi, Tenebio, TELIX, Tessa, Theragnostics, and Z-
Novartis, Pfizer, Pierre Fabre Oncology, Roche, Sandoz, Sanofi, and Sea- alpha; grant/research support from Advanced Accelerator Applications,
Gen; nonfinancial interests (panel member): EAU Prostate Cancer Guide- Amgen, Arvinas, AstraZeneca, Bayer, Constellation, Endocyte, Invitae,
lines Panel, ESMO bladder cancer practice guidelines, S3 Blasenkarzinom Janssen, Lantheus, Merck, Progenics, and Tenebio; and equity interests
Leitlinie, and IABC panel member. Rudi Dierckx and Uta Eberlein: none. at Ratio and Telix. Mike Sathekge: speaker funding from IBA and Sanofi;
Louise Emmett: advisory function at Clarity Pharma; and research sup- board member of Adcock Ingram and AHRI; trials (national PI)—AcTiON
port from Astellas, Clovis, Clarity, and Novartis. Stefano Fanti: AAA, ANMI, (Novartis), NOBLE (Telix), COMPETE (ITM), and EPIC (Oncobeta). Roman
AstraZeneca, Bayer, Astellas, Blue Earth, IBA, Janssen, Novartis, Sanofi, Sosnowski: none. Derya Tilki: honoraria, consulting, research funding,
Sofie, GE Healthcare, Telix, and Tolero. Karim Fizazi: participation at advi- and travel expenses from AAA/Novartis, Apogepha, AstraZeneca, Exact
sory boards of and talks for Amgen, Astellas, AstraZeneca, Bayer, Clovis, Sciences, Janssen, Ipsen, miR Scientific, Pfizer, Roche, Takeda, and Tolero
Daiichi Sankyo, Janssen, MSD, Novartis/AAA, Pfizer, and Sanofi (honoraria Pharmaceuticals. Bertrand Tombal: Professor and Chairman, Division of
to Gustave Roussy, own institution); and participation at advisory boards Urology, Cliniques Universitaires Saint Luc, Brussels, Belgium; past Presi-
with personal honorarium for CureVac and Orion. Silke Gillessen: per- dent of European Organization of Research and Treatment of Cancer
sonal honoraria for participation in advisory boards from Amgen, MSD; (EORTC); and investigator and paid advisor for Amgen, Astellas, Bayer,
other honoraria from Radio-televisione Svizzera Italiana (RSI) and Janssen, Ferring, Novartis, Pfizer, Sanofi, and Myovant. Giorgio Treglia
German-speaking European School of Oncology (DESO); invited speaker and Nina Tunariu: none. Jochen Walz: speaker fee/Honoraria from AAA,
for ESMO, Swiss Group for Clinical Cancer Research (SAKK), Swiss Acad- Astellas, AstraZeneca, Bayer, Blue Earth Diagnostics, Ipsen, Janssen, Light-
emy of Multidisciplinary oncology (SAMO), Orikata Academy Research point Medical, Takeda, and Telix; and advisor/consultant for Astellas, Blue
Group, and China Anti-Cancer Association Genitourinary Oncology Com- Earth Diagnostics, Janssen, Lightpoint Medical, and Telix. Derya Yakar:
mittee (CACA-GU); speakers’ bureau for Janssen Cilag; travel grant from consultant for Astellas and research support from Siemens Healthineers.
ProteoMEdiX and AstraZeneca; institutional honoraria for participation
in advisory boards or in independent data monitoring committees and
Funding/Support and role of the sponsor: This research was funded by
steering committees from AAA International, Amgen, AstraZeneca, Astel-
the EANM and supported by unrestricted grants from Advanced Acceler-
las Pharma, Bayer, Bristol-Myers Squibb, Janssen, Modra Pharmaceuticals,
ator Applications—a Novartis company, Monrol, Spectrum Dynamics
MSD, Myriad Genetic, Novartis, Orion, Pfizer, Roche, Telixpharma, and
Medical Ltd., Blue Earth Diagnostics, GE HealthCare, ITM Isotope Tech-
Tolermo Pharmaceuticals; other honoraria from PeerVoice, Silvio Grasso
nologies Munich SE, Siemens Healthineers, and Telix Pharmaceuticals.
Consulting, and WebMD-Medscape; co-inventor on patent application
These sponsors had no direct or indirect influence on the programme
(WO 2009138392 A1) for a method for biomarker discover (granted in
and content of the EANM Focus 5 meeting and the writing or content of
China, Europe, Japan and the USA); Deputy of the ESMO Guidelines Com-
this consensus statement.
mittee for GU cancers; member of the Scientific Committee of ESMO
Guidelines; member of the EAU Guideline Panel for Prostate Cancer; past
Chair of the EORTC GU Group; and member of the STAMPEDE Trial Man- Acknowledgements: We would like to thank Evelyn Mansutti, Susanne
agement Group. Ken Herrmann: consultant/advisor for Bayer, IPSEN, Sofie Koebe, Andrea Csismazia, Jutta Peter, Petra Neubauer, Andreas Felser,
Biosciences, Aktis Oncology, MPM Capital, Bain Capital, SIRTEX, Curium, and Henrik Silber (all from EANM) for project management. We also
ABX, BTG/BSC, Adacap/Novartis, Endocyte, Janssen, Amgen, Theragnostics, acknowledge all who participated in EANM Focus 5 meeting and espe-
GE, and Siemens. Sandra Heskamp: research support from Telix, Merck, cially the patients who participated in clinical and research projects, mak-
and AstraZeneca; patent: PSMA-targeting ligands for multimodal applica- ing it possible to inform expert opinion.
tions (nr: 21155853.1). Andrei Iagaru: consultant for Clarity Pharmaceu-
ticals, Curium (EU), GE Healthcare, IRE Elit, and Novartis; advisory board
for Amgen and Telix; scientific advisory board for Clarity Pharmaceuti- Supplementary data
cals; and scientific steering committee for Novartis. Barbara Alicja
Jereczek-Fossa: research funding from AIRC Italian Association for Cancer
Supplementary data to this article can be found online at
Research (institutional grants), FIEO-CCM & FUV (institutional grants),
https://doi.org/10.1016/j.eururo.2023.09.003.
Accuray (institutional grant), and IBA (institutional grant); and travel
expenses or speaker fees from Janssen, Ferring, Bayer, Roche, Astellas,
Elekta, Carl Zeiss, Ipsen, Accuray, and IBA. Jolanta Kunikowska: consulting References
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Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003
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Please cite this article as: D.-E. Oprea-Lager, S. MacLennan, A. Bjartell et al., European Association of Nuclear Medicine Focus 5: Consensus on Molecular
Imaging and Theranostics in Prostate Cancer, Eur Urol (2023), https://doi.org/10.1016/j.eururo.2023.09.003