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HTA in nuclear medicine: [68Ga]PSMA PET/CT for patients with prostate cancer

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Abstract

The [68Ga]PSMA PET/CT has been an option on clinical research tools to stage and to restage prostate cancer patients, although, with promising results, this radiopharmaceutical cannot be commercialized yet. Hence, up to date, [68Ga]PSMA has been used in a clinical research context. Once regulatory body approved it for marketing, health systems are responsible for the reimbursement decision. Health Technology Assessments (HTA) tools should be considered to base and to help decision-makers to spread or not this new technology. Regarding [68Ga]PSMA, under HTA framework, the present study searched for secondary studies and hence assessed three systematic reviews with meta-analyses published considering prostate cancer patients in different scenarios, same imaging technology but different comparators and outputs. The secondary studies considered outputs such as accuracy, detectability, positivity and change of management. Using AMSTAR-2, the meta-analysis methods and results were evaluated with 16 questions able to identify critical weaknesses, such as risk of bias, publication bias, true effect, and study heterogeneity. To increase the observational number of patients, to register positive and negative findings, and consolidate regional and multi-center clinical data which were suggestions on study design, structure and statistics made to improve the quality in future primary and secondary studies.

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Fig. 1

Adapted from The Evidence Hierarchy, In Ebling Library 2015, from http://researchguides.ebling.library.wisc.edu/EBM/acquire

Fig. 2
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Abbreviations

[18F]FDG:

18F-fluorodeoxyglucose

AMSTAR:

A measurement tool to assess systematic reviews

BS:

Bone scan

BCR:

Biochemical recurrence

EANM:

European association of nuclear medicine

EAU:

European association of urology

[18F]FACB:

18F-fluorocyclobutane-1-carboxylic acid

FDA:

Food and drug administration

GRADE:

Grading of recommendations assessment, development and evaluation

HTA:

Health technology assessment

MRI:

Magnetic resonance imaging

PRISMA:

Preferred reporting items for systematic review and meta-analysis

PICO:

Population, intervention, comparator, outcome

PSA:

Prostate specific antigen

PSMA:

Prostate-specific membrane antigen

QUADAS-2:

Quality assessment of diagnostic accuracy studies

RoB:

Risk of bias

SNMMI:

Society of nuclear medicine and molecular imaging

SR/MA:

Systematic review and meta-analysis

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Acknowledgements

The authors would like to thank IPEN—CNEN/SP and University of Bologna for the possibility of carrying out this collaborative work. This work was possible also due to the collaboration with the Agenzia Sanitaria e Sociale Regionale Regione Emilia-Romagna and the authors would like to thank especially Dr. Susanna Maltoni for make this possible and Maria Camerlingo for the valuable help during the bibliographic search.

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Authors report no special funding for this work.

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Authors and Affiliations

  1. Instituto de Pesquisas Energéticas e Nucleares, São Paulo, SP, Brazil

    Lorena Pozzo & Lucilena Rebelo Monteiro

  2. Quanta Diagnóstico Nuclear, Curitiba, PR, Brazil

    Juliano Julio Cerci

  3. Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy

    Stefano Fanti

  4. Agenzia Sanitaria e Sociale Regionale Regione Emilia-Romagna, Bologna, Italy

    Antonella Negro

  5. Coordenadoria de Ciência, Tecnologia e Inovação em Saúde, Núcleo de Avaliação de Tecnologia da Saúde, Secretatia de Saúde do Estado de São Paulo, Sao Paulo, SP, Brazil

    Evelinda Trindade

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  1. Lorena Pozzo
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  3. Juliano Julio Cerci
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  4. Stefano Fanti
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Contributions

LP was responsible for conception, search and data extraction, analysis, writing, and revision. LRM was responsible for statistical analysis evaluation, writing, and revision. JJC and SF were responsible for clinical discussion and revision. ET was responsible for study selection and revision. AN was responsible for HTA discussion and revision.

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Correspondence to Lorena Pozzo.

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Pozzo, L., Monteiro, L.R., Cerci, J.J. et al. HTA in nuclear medicine: [68Ga]PSMA PET/CT for patients with prostate cancer. Clin Transl Imaging 7, 7–20 (2019). https://doi.org/10.1007/s40336-019-00313-8

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