Study provides prospective validation of an alternative biopsy technique

Targeted biopsy with perilesional sampling may be the next direction in prostate cancer, according to findings presented at the ESMO Asia Congress 2025 which showed a non-inferiority of index lesion-focused ipsilateral systematic biopsy (iSB) over systematic biopsy (SB) (Abstract 488O).

Upfront magnetic resonance imaging (MRI) followed by an MRI-directed targeted biopsy (TB) plus systematic biopsy (SB) is the recommended diagnostic approach in MRI-positive cases of prostate cancer (European Urology, Volume 86, Issue 2, 148 - 163 ). However, the use of complementary SB is currently disputed as it can increase unnecessary biopsy cores, potential harms, and patient burdens, and identify indolent cancers in men with false-positive MRI scans (Eur Urol Open Sci. 2022 May 2;40:95–103 ).

In a prospective multicenter trial, 564 biopsy-naïve men with prostate cancer (prostate-specific antigen (PSA) > 4 ng/ml; lesions on MRI PI-RADS ≥ 4 or PI-RADS 3 with a PSA density ≥ 0.15 ng/mL/cm³) were enrolled and underwent MRI-targeted biopsy (≥ 2 cores/lesion) with 12-core SB. Through core-level reclassification, researchers simulated TB+iSB (targeted cores + ipsilateral systematic cores from the index lesion lobe).

The TB+iSB approach demonstrated a non-inferior cancer detection rate (CDR) of clinically significant prostate cancer (cisPCa) versus TB+SB (40.78% vs 42.38%; difference, -1.6%, 95% CI [-2.69, -0.5]), with the 95% CI lower bound not exceeding the -3% non-inferiority margin. The CDR of cisPCa with TB+iSB was slightly lower than that with TB+SB (13.83% vs 14.36%; difference, -0.53%, 95% CI [-2.0, -0.92]) (Figure). Among the 189 surgical patients, the modifications of pathological grades following surgery between the two methods were similar.

The results provide a first prospective validation of an alternative biopsy technique over the current standard approach.