To compare the diagnostic performance of 68Ga-PSMA PET/TC with PRI-MUS (prostate risk identification using micro-ultrasound) in the primary diagnosis of prostate cancer (PCa).
From September till December 2018, we prospectively enrolled 25 candidates to 68Ga-PSMA PET/TRUS (transrectal ultrasound) fusion biopsy and compared them with PRI-MUS. This included patients with persistently elevated PSA and/or PHI (prostate health index) suspicious for PCa, negative digital rectal examination, with either negative or contraindication to mpMRI, and at least one negative biopsy. The diagnostic performance of the two modalities was calculated based on pathology results.
Overall, 20 patients were addressed to 68Ga-PSMA PET/TRUS fusion biopsy. Mean SUVmax and SUVratio for PCa lesions resulted significantly higher than in benign lesions (p = 0.041 and 0.011, respectively). Using optimal cut-off points, 68Ga-PSMA PET/CT demonstrated an overall accuracy of 83% for SUVmax ≥ 5.4 and 94% for SUVratio ≥ 2.2 in the detection of clinically significant PCa (GS ≥ 7). On counterpart, PRI-MUS results were: score 3 in nine patients (45%), score 4 in ten patients (50%), and one patient with score 5. PRI-MUS score 4 and 5 demonstrated an overall accuracy of 61% in detecting clinically significant PCa.
In this highly-selected patient population, in comparison to PRI-MUS, 68Ga-PSMA PET/CT shows a higher diagnostic performance.
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The authors would like to thank at first all patients who have adhered to the study. A personal acknowledgement goes to all colleagues, nuclear medicine technologists and radiopharmacists, for the support in this research.
No founding was received for the current study.
Conflict of interest
E.L. reports receiving grants from Fondazione AIRC (Associazione Italiana per la Ricerca sul Cancro) and from the Italian Ministry of Health, and faculty remuneration from ESMIT (European School of Multimodality Imaging & Therapy) and MI&T congress. A. Chiti received speaker honoraria from General Electric and Sirtex Medical System, acted as scientific advisor to Blue Earth Diagnostics and Advanced Accelerator Applications, and benefited from an unconditional grant from Sanofi to Humanitas University. All honoraria are outside the scope of the submitted work.
All legal requirements were met in accomplishing this study (including ethical and radiation protection regulations). All procedures performed in the protocol ICH/382/216 protocol involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the principles of the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
All patients have signed the informed consent prior to any investigation.
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Lopci, E., Lughezzani, G., Castello, A. et al. PSMA-PET and micro-ultrasound potential in the diagnostic pathway of prostate cancer. Clin Transl Oncol 23, 172–178 (2021). https://doi.org/10.1007/s12094-020-02384-w
- 68Ga-PSMA PET/CT
- Prostate cancer
- Fusion biopsy
- Diagnostic accuracy