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Lymph node staging with fluorine-18 prostate specific membrane antigen 1007-positron emission tomography/computed tomography in newly diagnosed intermediate- to high-risk prostate cancer using histopathological evaluation of extended pelvic node dissection as reference

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Abstract

Purpose

Fluorine-18 (18F) prostate–specific membrane antigen (PSMA) 1007 (18F-PSMA-1007) is a radiotracer used in prostate cancer (PCa) staging. So far, no large histopathological validation study has been conducted. The objective was to determine diagnostic accuracy of 18F-PSMA-1007 PET/CT compared to histopathological results of extended pelvic lymph node dissection (ePLND) in men with intermediate- or high-risk PCa.

Methods

Men with newly confirmed intermediate- or high-risk PCa were prospectively enrolled in the Molecular Imaging 18F-PSMA-1007 PET/CT for lymph Node sTaging in primary PCa (MINT) trial. PET/CT images were read by two nuclear medicine physicians. Diagnostic accuracy was evaluated by histopathology of template resections. Sensitivity, specificity, and positive and negative predictive values (PPV, NPV) for LNI detection of 18F-PSMA-1007 PET/CT were calculated.

Results

Ninety-nine men were evaluated; 30.3% showed histologically confirmed LNI. Median number of resected nodes was 22 (IQR 17–28). Patient-based sensitivity, specificity, PPV, and NPV were 53.3% (95% CI 34.3–71.7%), 89.9% (95% CI 80.2–95.8%), 69.6% (95% CI 51.2–83.3%), and 81.6% (95% CI 75.0–86.8%), respectively. Template-based sensitivity was 12.9% (95% CI 5.7–23.9%), specificity 97.7% (95% CI 96.6–98.5%), PPV 23.5% (95% CI 12.7–39.5%), and NPV 95.3% (95% CI 94.9–95.7%).

Conclusion

18F-PSMA-1007 PET/CT showed high specificity but moderate to low sensitivity for LNI detection in intermediate- and high-risk PCa. It cannot replace ePLND for staging. Additional studies are needed to determine exact scan indications in lymph node staging for the primary diagnostic pathway in intermediate- or high-risk PCa.

Trial registry

December 12, 2018, Netherlands Trial Registry, NTR7670 (https://www.trialregister.nl/trial/7428).

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Data availability

Requests for specific data including a proposal, can be sent to e.wedick@cwz.nl. Data will be shared after proposal approval and with a signed data access agreement of the requesting researcher. Shared data would include anonymized individual patient data, study protocol and plan for statistical analysis.

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Author notes

  1. Rick Hermsen and Esmée Wedick contributed equally to this work.

Authors and Affiliations

  1. Department of Nuclear Medicine, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands

    Rick Hermsen & Maarten J. M. Vinken

  2. Department of Urology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands

    Esmée B. C. Wedick, Diederik M. Somford & Jean-Paul A. van Basten

  3. Department of Nuclear Medicine, University Medical Center, Utrecht, The Netherlands

    Ludwike W. M. van Kalmthout

  4. Department of Pathology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands

    Heidi V. N. Küsters-Vandevelde

  5. CWZ Academy, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands

    Charlotte H. W. Wijers

  6. Prosper Prostate Cancer Clinics, Nijmegen, The Netherlands

    Diederik M. Somford & Jean-Paul A. van Basten

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  1. Rick Hermsen
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Contributions

Ludwike van Kalmthout, Rick Hermsen, Jean-Paul van Basten, and Esmée Wedick contributed to the study conception and design. Data collection was performed by Esmée Wedick, Rick Hermsen, and Maarten Vinken. Statistical analysis was done by Charlotte Wijers and Esmée Wedick. Analysis and interpretation of data were performed by Esmée Wedick, Rick Hermsen, Jean-Paul van Basten, and Charlotte Wijers. The first draft of the manuscript was written by Esmée Wedick, Rick Hermsen, and Jean-Paul van Basten, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jean-Paul A. van Basten.

Ethics declarations

Jean-Paul van Basten, corresponding author of this manuscript, certifies that the contributors and conflicts of interest statements included in this paper are correct and have been approved by all co-authors. Michiel Sedelaar, PhD, Urologist, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Ethics approval

The Medical Ethics Review Committee (registration number: 2018–4294) confirmed that the Medical Research Involving Human Subjects Act does not apply to this study.

Consent to participate and consent to publish

Written informed consent for participation and publication of the study was acquired from all patients before inclusion.

Competing interests

The authors declare no competing interests.

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This article is part of the Topical Collection on Oncology - Genitourinary

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Hermsen, R., Wedick, E.B.C., Vinken, M.J.M. et al. Lymph node staging with fluorine-18 prostate specific membrane antigen 1007-positron emission tomography/computed tomography in newly diagnosed intermediate- to high-risk prostate cancer using histopathological evaluation of extended pelvic node dissection as reference. Eur J Nucl Med Mol Imaging 49, 3929–3937 (2022). https://doi.org/10.1007/s00259-022-05827-4

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