[Can prostate biopsy be replaced?] Feasibility of mpMRI combined with 18F-PSMA PET/CT in the diagnosis of prostate cancer

Abstract Objective To investigate whether multiparameter magnetic resonance imaging (mpMRI) combined with 18F-Prostate-specific membrane antigen (PSMA) PET/CT can replace prostate biopsy in the diagnosis of prostate cancer. Materials and methods This is a prospectively Three-arm Clinical Trial which enrolled 150 patients with suspected prostate cancer (PI-RADs ≥ 3 score) from Zhejiang Provincial People's Hospital between September 2020 to January 2023. Patients were screened and divided into three cohorts to undergo the PSMA-PET procedure, transperineally MRI-targeted biopsy (TB-TRUS), and conventional transrectal ultrasound-guided systematic biopsy (SB-TRUS). All patients required radical prostatectomy according to the treatment procedure and perioperative information was collected. Comparison of baseline patient characteristics, detection and omission rates for various screening methods, and perioperative information between the three groups. Results A total of 109 patients were included in this study. The median age was 68.4 (64.0-73.5) years old. The median PSA was 13.0 (7.1–15.0) ng/ml, the median prostate volume was 42.0 (24.6–53.8) ml, and the median PSA density (PSAD) was 0.36 (0.19–0.47) ng/ml2. 48 patients had PI-RADS scores of 3, 41 patients had scores of 4, and 20 patients had scores of 5. The median SUVmax of 18F-PSMA PET/CT was 15.41 (12.18–17.58). There were no significant differences in baseline characteristics among the three cohorts. The detection rate of prostate cancer in the Sa cohort was much lower than that in the Pa and Ma cohorts (P<0.001), and the missed diagnosis rate in the Sa cohort was much higher than that in the other two groups (P<0.001). The Intraoperative bleeding, surgery time and Hospitalization days in the Pa cohort were much higher than those in the other two cohorts (P<0.001). Conclusion MpMRI combined with 18F-PSMA PET/CT has high accuracy in the diagnosis of prostate cancer. For patients with highly suspected localized prostate cancer, radical prostatectomy without biopsy is safe, and can be attempted on the premise of adequate communication.