Diagnostic yield of fusion magnetic resonance-guided prostate biopsy versus cognitive-guided biopsy in biopsy-naive patients: a head-to-head randomized controlled trial.

Background: The combination of MRI-guided targeted biopsy (MRGB) with systematic biopsy (SB) provides the highest accuracy in detecting prostate cancer. There is a controversy over the superiority of fusion targeted biopsy (fus-MRGB) over cognitive targeted biopsy (cog-MRGB). The present head-to-head randomized controlled trial was performed to compare diagnostic yield of fus-MRGB in combination with SB with cog-MRGB in combination with SB.

Methods: Biopsy-naive patients with a prostate-specific antigen level between 2 and 10 ng/dL who were candidates for prostate biopsy were included in the study. Multiparametric MRI was performed on all patients and patients with suspicious lesions with Prostate Imaging Reporting and Data System score of 3 or more were randomized into two groups. In the cog-MRGB group, a targeted cognitive biopsy was performed followed by a 12-core SB. Similarly, in the fus-MRGB group, first targeted fusion biopsy and then SBs were performed. The overall and clinically significant prostate cancer detection rates between the two study groups were compared by the Pearson χ test. McNemar test was used to compare detection rates yielded by SB and targeted biopsy in each study group.

Results: One-hundred men in the cog-MRGB group and 99 men in the fus-MRGB group were compared. The baseline characteristics of patients including age, PSA level, prostate volume, PSA density, and clinical stage were similar in the two groups (p > 0.05). Both the overall and clinically significant prostate cancer detection rates in the fus-MRGB group (44.4% and 33.3%, respectively) were significantly higher than cog-MRGB group (31.0% and 19.0%, respectively) (p = 0.035 and p = 0.016, respectively).

Conclusion: The accuracy of identifying overall and clinically significant prostate cancer by fus-MRGB in biopsy-naive patients with PSA levels between 2 and 10 ng/dL is significantly higher than cog-MRGB and if available, we recommend using fus-MRGB over cog-MRGB in these patients.