Ultrasound/MRI-targeted biopsy versus saturated trans-rectal ultrasound guided biopsy of prostate in patients with primary negative conventional biopsy and still elevated PSA: a prospective randomized clinical trial.

Introduction: To evaluate and compare the rate of cancer detection by two methods Saturated TRUS guided biopsy and ultrasound/magnetic resonance imaging (US/MRI)-targeted biopsy in patients with primary negative prostate cancer in standard 12 cores biopsy evaluation but still have elevated prostate specific antigen (PSA).

Materials and methods: From 105 patients who met our inclusion criteria, 53 patients underwent US/MRI-targeted biopsy and 52 remaining patients underwent Saturated 20 core TRUS guided biopsy in a prospective randomized clinical trial.

Results: The mean age (±SD) was 62.2 (±8.2) year. The mean PSA (±SD) was 11.8 (±7.5) ng/ml. The mean prostate volume was 56.1 (±24.8) ml. Adenocarcinoma of prostate was detected in 9/52 (17.3%) patients in groups saturated biopsy and 14/53 (26.4%) patients in US/MRI-targeted biopsy group and there was no difference in cancer detection rate between 2 groups (P=0.252). except four patients with fever (two in each group), there was no other serious complication (Clavien grade 3 or higher) occurred in the patients. In the multivariate analysis, higher pre-procedure PSA, lower size of the prostate, pathology of ASAP and presence of nodule in DRE were independent predictors for cancer detection in second biopsy (P=0.036, P<0.001, P=0.013 and P=0.031, respectively).

Conclusion: We didn't find any superiority in cancer detection rate and any different in complication rate between these two methods saturated TRUS guided biopsy and US/MRI-targeted biopsy.