Magnetic resonance imaging‐targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer: A multicenter, paired, noninferiority, observational trial
Yongbing Cheng, Haifeng Huang, Miao Wang, Liangyong Zhu, Shan Peng, Danyan Li, Giancarlo Marra, Ruowen Qi, Xuefei Ding, Ming Liu, Xuefeng Qiu, Hongqian GuoAbstract
Background
Index lesion‐focused ipsilateral systematic biopsy (iSB) has been proposed as a core‐reduction alternative to MRI‐targeted biopsy combined with systematic biopsy (TB + SB) for prostate cancer, but prospective multicenter validation is limited.
Methods
This prospective multicenter trial (NCT06584279) enrolled biopsy‐naive men with Prostate Imaging Reporting and Data System (PI‐RADS) ≥4 lesions or PI‐RADS 3 plus prostate‐specific antigen (PSA) density ≥0.15 ng/mL/cm 3 . All underwent MRI‐targeted biopsy (≥2 cores/lesion) with 12‐core SB. Through core‐level reclassification, the authors simulated TB + iSB (targeted biopsy combined with index lesion‐ipsilateral systematic biopsy). The primary outcome was cancer detection rate (CDR) of clinically significant prostate cancer (csPCa; Grade Group ≥2) with a noninferiority margin of –3%. Secondary outcomes included clinically insignificant prostate cancer (cisPCa; Grade Group 1) detection and pathological concordance after radical prostatectomy.
Results
Among 564 men (median age, 69 years; median PSA, 7.3 ng/mL), TB + iSB demonstrated a noninferior csPCa CDR versus TB + SB (40.78% vs. 42.38%; difference, –1.6 percentage points; 95% CI, –2.69 to –0.50), with the lower bound above the –3% noninferiority margin. The cisPCa CDR was slightly lower with TB + iSB than with TB + SB (13.83% vs. 14.36%; difference, –0.53 percentage points; 95% CI, –2.01 to 0.92). Among 189 surgical patients, pathological concordance was similar, whereas upgrading was numerically more frequent and downgrading numerically less frequent under simulated TB + iSB.
Conclusions
TB + iSB met the prespecified noninferiority criterion for csPCa detection relative to TB + SB and may represent a promising core‐reduction strategy in transperineal MRI‐guided biopsy, although the full protocol still provided additional contralateral information.