Is targeted magnetic resonance imaging/transrectal ultrasound fusion prostate biopsy enough for the detection of prostate cancer in patients with PI-RADS ≥3: Results of a prospective, randomized clinical trial.

Objective: To evaluate targeted magnetic resonance imaging/transrectal ultrasound (MRI/TRUS) fusion prostate biopsy versus systematic prostate biopsy and the two approaches combined for the detection of prostate cancer (PCa) and clinically significant PCa (csPCa) in our center.

Patients And Methods: From September 2018 to June 2020, a total of 161 patients with PI-RADS ≥3 were enrolled in this study. They were randomly to undergo either systematic prostate biopsy (systematic group) or targeted MRI/TRUS fusion prostate biopsy + systematic prostate biopsy (combined group). The clinical data and pathological results of biopsies were analyzed.

Results: The detection rate of PCa by targeted MRI/TRUS fusion prostate biopsy was higher than systematic prostate biopsy (38/81 vs. 33/81) in combinated group, but there was no significantly difference. The PCa detection rate in combinated group was significantly higher than systematic group (47/81 vs. 34/80, P = 0.049). There were 40 patients in combinated group and 22 patients in systematic group diagnosed as csPCa, respectively. The ratio of detected csPCa was much higher in combinated group (P = 0.032). In Gleason score no more than 6, the detected ratio of targeted MRI/TRUS fusion prostate biopsy was significantly lower than systematic biopsies in combinated group (P = 0.044). While, in Gleason score higher than 6, the detected ratios of targeted MRI/TRUS fusion prostate biopsy were all higher than systematic biopsies.

Conclusions: Among patients with PI-RADS ≥ 3, targeted MRI/TRUS fusion prostate biopsy is superior to systematic prostate biopsy in the detection rate of PCa and csPCa, but it still misses some PCa patients, including csPCa. Combining targeted MRI/TRUS fusion prostate biopsy and systematic prostate biopsy can led to more detection of all PCas, especially csPCa.