Comparison between 18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy and systematic biopsy for tumor detection and grading in selected patients: A prospective randomized controlled trial

Objective: This study aimed to compare the upgrade rate and cancer detection rate between the 18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy (TB) and systematic biopsy in selected patients with suspected prostate cancer (the molecular imaging prostate-specific membrane antigen score of ≥2 and multiparametric MRI Prostate Imaging Reporting and Data System score of ≥4). Methods: Eighty-seven selected biopsy-naive patients were randomized into two groups: TB (n=41) and systematic biopsy (control; n=46). Patients diagnosed with clinically significant prostate cancer proceeded to radical prostatectomy. The primary outcome was the pathological upgrade rate. Secondary outcomes, including the cancer detection rate, incidence of repeat biopsy, positive surgical margin, complications, and prostate-specific antigen level at 6 weeks postoperatively, were compared between the groups using the Pearson or Fisher's exact test, as appropriate. Results: In the study, prostate cancer was ultimately detected in all patients. The TB group successfully identified all tumors, whereas five patients in the control group initially missed diagnosis. The pathological upgrade rates for the TB and control groups were 31.7 % and 56.5%, respectively. Overall, the detection rate for clinically significant prostate cancer (the International Society of Urological Pathology grade of ≥2) was significantly higher in the TB group (92.7%) compared with the control group (76.1%, p=0.035). However, no significant difference was found in the detection rate of all prostate cancer. Complications (Clavien–Dindo grade of ≤2) occurred in both the TB group (n=11) and control group (n=13). No statistically significant difference was observed between the groups in terms of the positive surgical margin, complications, or 6-week postoperative prostate-specific antigen level. Conclusion: The 18F-DCFPyL PET/MRI-guided ultrasound fusion TB alone was an efficient modality in diagnosing selected patients with prostate cancer.