Using a novel PSMA-PET and PSA-based model to enhance the diagnostic accuracy for clinically significant prostate cancer and avoid unnecessary biopsy in men with PI-RADS ≤ 3 MRI.

Introduction: The diagnostic evaluation of men with suspected prostate cancer (PCa) yet inconclusive MRI (PI-RADS ≤ 3) presents a common clinical challenge. [68Ga]Ga-labelled prostate-specific membrane antigen ([68Ga]Ga-PSMA) positron emission tomography/computed tomography (PET/CT) has shown promis...

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Published in:European Journal of Nuclear Medicine & Molecular Imaging Vol. 52; no. 3; pp. 913 - 925
Main Authors: Li, Yujia, Li, Jian, Yang, Jinhui, Xiao, Ling, Zhou, Ming, Cai, Yi, Rominger, Axel, Shi, Kuangyu, Seifert, Robert, Gao, Xiaomei, Tang, Yongxiang, Hu, Shuo
Format: Journal Article
Published: Springer Nature Feb2025
Online Access:View this record in EBSCOhost
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      dt: Feb2025
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      pub: Springer Nature
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        10.1007/s00259-024-06949-7
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        atl: Using a novel PSMA-PET and PSA-based model to enhance the diagnostic accuracy for clinically significant prostate cancer and avoid unnecessary biopsy in men with PI-RADS ≤ 3 MRI.
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        au:
          Li, Yujia
          Li, Jian
          Yang, Jinhui
          Xiao, Ling
          Zhou, Ming
          Cai, Yi
          Rominger, Axel
          Shi, Kuangyu
          Seifert, Robert
          Gao, Xiaomei
          Tang, Yongxiang
          Hu, Shuo
        affil: https://ror.org/05c1yfj14 Department of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China
      sug:
      ab: Introduction: The diagnostic evaluation of men with suspected prostate cancer (PCa) yet inconclusive MRI (PI-RADS ≤ 3) presents a common clinical challenge. [68Ga]Ga-labelled prostate-specific membrane antigen ([68Ga]Ga-PSMA) positron emission tomography/computed tomography (PET/CT) has shown promise in identifying clinically significant PCa (csPCa). We aim to establish a diagnostic model incorporating PSMA-PET to enhance the diagnostic process of csPCa in PI-RADS ≤ 3 men. Materials and Methods: This study retrospective included 151 men with clinical suspicion of PCa and PI-RADS ≤ 3 MRI. All men underwent [68Ga]Ga-PSMA PET/CT scans and ultrasound/MRI/PET fusion-guided biopsies. csPCa was defined as Grade Group ≥ 2. PRIMARY-scores from PSMA-PET scans were evaluated. A diagnostic model incorporating PSMA-PET and prostate-specific antigen (PSA)-derived parameters was developed. The discriminative performance and clinical utility were compared with conventional methods. Internal validation was conducted using a fivefold cross-validation with 1000 iterations. Results: In this PI-RADS ≤ 3 cohort, areas-under-the-curve (AUCs) for detecting csPCa were 0.796 (95%CI, 0.738–0.853), 0.851 (95%CI, 0.783–0.918) and 0.806 (95%CI, 0.742–0.870) for PRIMARY-score, SUVmax and routine clinical PSMA-PET assessment, respectively. The diagnostic model comprising PRIMARY-score, SUVmax and serum free PSA/total PSA (fPSA/tPSA) achieved a significantly higher AUC of 0.906 (95%CI, 0.851–0.961) compared to strategies based on PRIMARY-score or SUVmax (P < 0.05) and markedly superior to conventional strategies typically based on PSA density (P < 0.001). The average fivefold cross-validated AUC with 1000 iterations was 0.878 (95%CI, 0.820–0.954). Theoretically, using a threshold of 21.6%, the model could have prevented 78% of unnecessary biopsies while missing only 7.8% of csPCa cases in this cohort. Conclusions: A novel diagnostic model incorporating PSMA-PET derived metrics—PRIMARY-score and SUVmax—along with serum fPSA/tPSA, has been developed and validated. The integrated model may assist clinical decision-making with enhanced diagnostic accuracy over the individual conventional metrics. It has great potential to reduce unnecessary biopsies for men with PI-RADS ≤ 3 MRI results and warrants further prospective and external evaluations.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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