Targeted, Perilesional, and Distant Biopsies in Prostate Cancer.

[BACKGROUND AND OBJECTIVE] Targeted plus perilesional biopsies are recommended for men with prostate lesions visible on magnetic resonance imaging. However, available data are mainly retrospective, without predefined biopsy scheme protocols. The MRI-Integrated Regional and targeted Approach, recommendations, and Guidelines for prostate biopsies (MIRAGE) study is the first prospective European study designed to evaluate the outcomes when perilesional biopsies are incorporated deliberately into the biopsy protocol.

[METHODS] MIRAGE was a prospective, observational, multicenter study conducted across ten European centers between January and June 2025. We enrolled 912 men with a single Prostate Imaging Reporting and Data System (PI-RADS) ≥3 lesion. Targeted and perilesional biopsies were mandated, while distant biopsies (ie, cores taken beyond the perilesional zone) were left to the discretion of investigators. Detection rates of Gleason grade (GG) group ≥2 and 1 lesions were calculated separately for each scheme: targeted, perilesional, and distant biopsies.

[KEY FINDINGS AND LIMITATIONS] Targeted biopsy detected GG group ≥2 lesions in 380 men (41%). Compared with targeted biopsy alone, perilesional sampling increased GG group ≥2 lesion detection by +3.6% at the cost of +1% GG group 1 lesion detection. The greatest benefit of perilesional sampling was observed in biopsy-naïve men and those with PI-RADS 4-5 lesions. Conversely, in those with PI-RADS 3 or a prior negative biopsy, perilesional sampling yielded more cases of GG group 1 than of GG group ≥2. Distant sampling provided minimal incremental GG group ≥2 (contralateral: +1.6%; ipsilateral: +1.4%) but more GG group 1 (contralateral: +2.5%; ipsilateral: +2.9%) cases.

[CONCLUSIONS AND CLINICAL IMPLICATIONS] The MIRAGE study provides prospective evidence that, when a targeted plus perilesional biopsy strategy is applied, distant biopsies add minimal diagnostic benefit and should be omitted.