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. 2025 Feb;52(3):913-924.
doi: 10.1007/s00259-024-06949-7. Epub 2024 Oct 15.

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

Yujia Li #  1 , Jian Li #  1 , Jinhui Yang  1 , Ling Xiao  1 , Ming Zhou  1 , Yi Cai  2   3 , Axel Rominger  4 , Kuangyu Shi  4   5 , Robert Seifert  4 , Xiaomei Gao  6 , Yongxiang Tang  7   8   9   10 , Shuo Hu  11   12   13
Affiliations

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

Yujia Li et al. Eur J Nucl Med Mol Imaging. 2025 Feb.

Abstract

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.

Keywords: MpMRI; PET; PI-RADS; PRIMARY-score; PSMA; Prostate cancer.

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Conflict of interest statement

Declarations. Conflicts of interest: AR and KS are editors of the journal European Journal of Nuclear Medicine and Molecular Imaging. RS has received research/travel support from the Boehringer Ingelheim Fund and the Else Kröner-Fresenius-Stiftung. The other authors have no relevant financial or non-financial interests to disclose. Ethics approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the Declaration of Helsinki and its later amendments or comparable ethical standards. The study was approved by the Ethics Committee of Xiangya Hospital, Central South University (201909253) and ethics review board (NCT05073653, Registration Date: 2021–10-11). Consent to participate: Written informed consent was obtained from all individual participants included in the study. Consent to publish: Patients signed informed consent regarding publishing their data and photograph.

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