Efficacy of transrectal mpMRI / TRUS fusion-guided biopsy of the prostate: results of a study in 318 patients

Introduction . Prostate cancer remains one of the leading oncological diseases among men, necessitating precise diagnostic strategies. Contemporary approaches, including multiparametric MRI (mpMRI) with PI-RADS scoring and targeted biopsy, enhance detection of clinically significant prostate cancer (csPCa), reduce unnecessary procedures, and minimize complications. Objective . To evaluate the efficacy of transrectal mpMRI/transrectal ultrasound (TRUS) fusion-guided prostate biopsy in detecting csPCa. Materials & methods . We prospectively evaluated 318 patients who underwent transrectal mpMRI/TRUS fusion-guided prostate biopsy. All patients had pre-biopsy mpMRI with PI-RADS scoring, prostate-specific antigen (PSA) levels, PSA density, and digital rectal examination (DRE). Biopsies employed a combined approach: targeted sampling of mpMRIidentified lesions plus systematic sampling. Prostate cancer detection rates (csPCa defined as ISUP grade ≥ 2) were correlated with PI-RADS score, PSA density, and DRE findings. Detection rates were compared between biopsy-naïve and repeat-biopsy patients. Complications were systematically recorded. Results . csPCa was detected in 40% of patients overall (43% in biopsy-naïve vs. 35% in repeat-biopsy patients; p > 0.05). Lesions scored PI-RADS 4 – 5 yielded significantly higher csPCa detection rates than PI-RADS 3 lesions. Among PI-RADS 3 cases, PSA density > 0.15 ng/mL/cm³ predicted higher csPCa risk, while lower values indicated low risk. Positive DRE also correlated with csPCa detection. Targeted biopsy detected most csPCa cases, but systematic sampling increased the overall yield by 10%. No severe complications (e.g., sepsis or major hemorrhage) occurred; minor, transient events such as hematuria or fever affected < 5% of patients. Conclusions . Transrectal mpMRI/TRUS fusion-guided biopsy is highly effective for csPCa detection. Pre-biopsy mpMRI combined with targeted plus systematic sampling optimizes diagnostic yield while maintaining a favorable safety profile.