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Background <p>To investigate the diagnostic performance and interreader agreement of intraprostatic prostate cancer (PCa) detection, local extension and staging using [<sup>18</sup>F]PSMA-1007 PET in primary PCa, with whole-mount radical prostatectomy specimens as the reference standard. This prospective study included 66 patients with biopsy-proven PCa who underwent [<sup>18</sup>F]PSMA-1007 PET/MRI prior to radical prostatectomy. Four nuclear medicine physicians independently evaluated intraprostatic lesions, T stage, extracapsular extension (ECE), seminal vesicle invasion (SVI) and bilaterality, based on PROMISE V2 criteria and a standardized scoring template. Diagnostic accuracy was calculated using whole-mount histopathology as reference. Interreader agreement was assessed using Fleiss’ and weighted kappa statistics.</p> Results <p>Accurate lesion-level detection of dominant intraprostatic malignant lesions was achieved across readers with mean sensitivity of 96% (range 96–97%). Mean (range) sensitivity for detecting T3a, T3b, ≥T3, ECE, SVI and bilaterality across readers was 23% (0–50%), 39% (16–53%), 40% (10–63%), 33% (5–59%), 43% (16–58%) and 44% (34–53%), respectively. Mean (range) specificity for detecting T3a, T3b, ≥T3, ECE, SVI and bilaterality across readers was 86% (75–100%), 99% (98–100%), 85% (72–100%), 88% (74–100%), 99% (98–100%) and 86% (71–100%), respectively. Interreader agreement was substantial for bilaterality (kappa 0.66), moderate for SVI (kappa 0.57), fair for T stage (kappa 0.37) and slight for ECE (kappa 0.20).</p> Conclusion <p>Accurate lesion-level detection of [<sup>18</sup>F]PSMA-1007 PET for dominant intraprostatic malignant lesions can be achieved across multiple readers. However, variable diagnostic performance of [<sup>18</sup>F]PSMA-1007 PET for local tumor extension was seen between readers, highlighting the need for standardized interpretation guidelines to improve reproducibility and clinical reliability.</p> Trial registration <p>ClinicalTrials.gov, NCT03327675. Registered 10 July 2017, <a href="https://clinicaltrials.gov/study/NCT03327675?term=NCT03327675%26rank=1">https://clinicaltrials.gov/study/NCT03327675?term=NCT03327675%26rank=1</a>.</p>

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Interreader agreement of intraprostatic prostate cancer detection, local extension and staging using [18F]PSMA-1007 PET and whole-mount radical prostatectomy specimens

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月9日

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  • Niloefar Ahmadi Bidakhvidi,
  • Elena Lara Jimenez,
  • Hannes Leupe,
  • Sander Jentjens,
  • Marcella Baldewijns,
  • Maxim De Schepper,
  • Annouschka Laenen,
  • Gaëtan Devos,
  • Alexander Giesen,
  • Michel Koole,
  • Christophe M. Deroose,
  • Wouter Everaerts,
  • Steven Joniau,
  • Karolien Goffin

摘要

Background

To investigate the diagnostic performance and interreader agreement of intraprostatic prostate cancer (PCa) detection, local extension and staging using [18F]PSMA-1007 PET in primary PCa, with whole-mount radical prostatectomy specimens as the reference standard. This prospective study included 66 patients with biopsy-proven PCa who underwent [18F]PSMA-1007 PET/MRI prior to radical prostatectomy. Four nuclear medicine physicians independently evaluated intraprostatic lesions, T stage, extracapsular extension (ECE), seminal vesicle invasion (SVI) and bilaterality, based on PROMISE V2 criteria and a standardized scoring template. Diagnostic accuracy was calculated using whole-mount histopathology as reference. Interreader agreement was assessed using Fleiss’ and weighted kappa statistics.

Results

Accurate lesion-level detection of dominant intraprostatic malignant lesions was achieved across readers with mean sensitivity of 96% (range 96–97%). Mean (range) sensitivity for detecting T3a, T3b, ≥T3, ECE, SVI and bilaterality across readers was 23% (0–50%), 39% (16–53%), 40% (10–63%), 33% (5–59%), 43% (16–58%) and 44% (34–53%), respectively. Mean (range) specificity for detecting T3a, T3b, ≥T3, ECE, SVI and bilaterality across readers was 86% (75–100%), 99% (98–100%), 85% (72–100%), 88% (74–100%), 99% (98–100%) and 86% (71–100%), respectively. Interreader agreement was substantial for bilaterality (kappa 0.66), moderate for SVI (kappa 0.57), fair for T stage (kappa 0.37) and slight for ECE (kappa 0.20).

Conclusion

Accurate lesion-level detection of [18F]PSMA-1007 PET for dominant intraprostatic malignant lesions can be achieved across multiple readers. However, variable diagnostic performance of [18F]PSMA-1007 PET for local tumor extension was seen between readers, highlighting the need for standardized interpretation guidelines to improve reproducibility and clinical reliability.

Trial registration

ClinicalTrials.gov, NCT03327675. Registered 10 July 2017, https://clinicaltrials.gov/study/NCT03327675?term=NCT03327675%26rank=1.