To evaluate the accuracy of 68Ga-PSMA PET/CT versus mpMRI targeted biopsy (TPBx) in the diagnosis of clinically significant prostate cancer (csPCa) in men high risk for PCa.
From January 2021 to March 2023, 125 men with clinical parameters high risk for PCa were evaluated by mpMRI and 68Ga-PSMA PET/CT; median PSA was 32.5 ng/mL (range: 12-160 ng/mL) and 60/125 (48%) had abnormal digital rectal examination. The mpMRI lesions with PI-RADS scores ≥ 3 and/or 68Ga-PSMA areas characterized by a standardized uptake value (SUVmax) values ≥ 8 were submitted to TPBx (4 cores); in addition, all the patients underwent systematic transperineal prostate biopsy (18 cores) under sedation and antibiotic prophylaxis.
In 80 of 125 men (64%) a csPCa was found: 10 (12.5%) had a ISUP Grade Group 3 (GG), 45 (56.2%) a ISUP GG4 and 25 (31.2%) ISUP GG5. The median intraprostatic 68Ga-PSMA SUVmax was 42.3 (range:10.5-164) and 72 of 80 (90%) had a PI-RADS score ≥ 3. 68GaPSMA PET/CT showed the presence of metastases in 20 of 80 (25%) men: the median SUVmax in bone (15 cases) and nodes (40 cases) metastases was 55 and 47, respectively. Accuracy of 68Ga PSMA PET/CT (SUVmax cut-off ≥ 8) versus mpMRI PI-RADS score ≥ 3 in the diagnosis of csPCa was 92 versus 86.2%.
68GaPSMA PET/CT demonstrated a good diagnostic accuracy as a single procedure for the diagnosis and staging of high-risk PCa.

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