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

Abstract

ObjectiveTo compare the upgrade rate and cancer detection rate between 18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy and systematic biopsy in selected patients with suspected prostate cancer (the multiparametric MRI prostate imaging reporting and data system score ≥4 and molecular imaging prostate-specific membrane antigen score of prostate-specific membrane antigen PET image ≥2). MethodsEighty-seven selected biopsy-naive patients were randomized into two groups: targeted biopsy (n=41) and systematic biopsy (control; n=46). Those with negative initial results underwent a repeat biopsy using the alternative method. Patients diagnosed with clinically significant prostate cancer proceed to radical prostatectomy. The primary outcome was the upgrade rate. Additional 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 Pearson or Fisher's exact tests, as appropriate. ResultsIn the study, prostate cancer was ultimately detected in all patients. The targeted biopsy group successfully identified all tumors, whereas five patients in the control group initially missed their tumors. The pathological upgrade rates for the targeted biopsy 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 ≥2) was significantly higher in the targeted biopsy 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 ≤2) occurred in both the targeted biopsy group (n=11) and the control group (n=13). No statistically significant difference was observed between the groups in terms of positive surgical margin, complications, and 6-week postoperative prostate-specific antigen level. The main limitation is the small population. Conclusion18F-DCFPyL PET/MRI-guided ultrasound fusion targeted biopsy alone was an efficient modality in diagnosing selected patients with prostate cancer.