European urology · 2026
Cognitive Versus Software-based Fusion Targeted Biopsy for the Diagnosis of Clinically Significant Prostate Cancer: A Multicenter, Randomized, Noninferiority Trial (IMAGINATION).
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He Bi-Ming, Zhang Keqin, Zhou Zhien, Chen Xingfa, Liu Yi, Dong Biao, Wang Yong, Xing Yaping, He WenQiang, Jin Zhichao, Zhang Tongqing, Feng Tianrui, Liang Liang, Chen Bo, Chen Shouzhen, Lu Zhenquan, Zhou Shuming, Zhao Yanfang, Liu Yingtao, Wang Zhimin, Na Rong, Zhang Xuepei, Shi Benkang, Wang Hai-Feng, IMAGINATION Group
Аннотация
BACKGROUND: Magnetic resonance imaging-targeted prostate biopsy relies heavily on costly software-fusion platforms, limiting global accessibility.
OBJECTIVE: We aimed to determine whether cognitive fusion (mental registration) is noninferior to software-based fusion targeted biopsy for detecting clinically significant prostate cancer (csPCa).
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, randomized, blinded, noninferiority trial enrolled 648 predominantly biopsy-naive men (prostate-specific antigen 4-20 ng/ml; Prostate Imaging Reporting and Data System ≥3) at nine centers in China.
INTERVENTION: Participants were randomly assigned 1:1 to cognitive fusion or software-based fusion targeted biopsy, followed by systematic biopsy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was csPCa (ISUP grade group ≥2) detection on targeted biopsy, evaluated using generalized estimating equations with a prespecified -10 percentage point noninferiority margin.
RESULTS AND LIMITATIONS: In the intention-to-treat population (327 cognitive and 321 software), targeted biopsy detected csPCa in 32% and 34% of the patients, respectively. The adjusted risk difference was -1.02 percentage points (90% confidence interval [CI], -5.6 to 3.6), establishing noninferiority. Combined targeted and systematic biopsy detected csPCa in 35-39% of the patients, respectively (difference, -1.50% [90% CI, -6.4 to 3.4]). A significant body mass index (BMI) interaction was observed (p < 0.001): cognitive fusion performed best in men with BMI <24 kg/m2, whereas software-based fusion improved detection in men with BMI ≥24 kg/m2. Adverse event rates were comparable (15% vs 18%). Limitations include conducting the trial predominantly in Asian populations, necessitating cautious geographic extrapolation of specific BMI cutoffs.
CONCLUSIONS: Cognitive fusion is diagnostically noninferior to software-based fusion within a prespecified -10% margin overall. However, a significant BMI interaction raises serious concerns regarding the diagnostic feasibility of cognitive fusion in obese populations, where software-based fusion is strictly superior. Future prospective trials in both Asian and Western populations must evaluate the BMI effect as a primary end point.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04271527.
OBJECTIVE: We aimed to determine whether cognitive fusion (mental registration) is noninferior to software-based fusion targeted biopsy for detecting clinically significant prostate cancer (csPCa).
DESIGN, SETTING, AND PARTICIPANTS: This multicenter, randomized, blinded, noninferiority trial enrolled 648 predominantly biopsy-naive men (prostate-specific antigen 4-20 ng/ml; Prostate Imaging Reporting and Data System ≥3) at nine centers in China.
INTERVENTION: Participants were randomly assigned 1:1 to cognitive fusion or software-based fusion targeted biopsy, followed by systematic biopsy.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was csPCa (ISUP grade group ≥2) detection on targeted biopsy, evaluated using generalized estimating equations with a prespecified -10 percentage point noninferiority margin.
RESULTS AND LIMITATIONS: In the intention-to-treat population (327 cognitive and 321 software), targeted biopsy detected csPCa in 32% and 34% of the patients, respectively. The adjusted risk difference was -1.02 percentage points (90% confidence interval [CI], -5.6 to 3.6), establishing noninferiority. Combined targeted and systematic biopsy detected csPCa in 35-39% of the patients, respectively (difference, -1.50% [90% CI, -6.4 to 3.4]). A significant body mass index (BMI) interaction was observed (p < 0.001): cognitive fusion performed best in men with BMI <24 kg/m2, whereas software-based fusion improved detection in men with BMI ≥24 kg/m2. Adverse event rates were comparable (15% vs 18%). Limitations include conducting the trial predominantly in Asian populations, necessitating cautious geographic extrapolation of specific BMI cutoffs.
CONCLUSIONS: Cognitive fusion is diagnostically noninferior to software-based fusion within a prespecified -10% margin overall. However, a significant BMI interaction raises serious concerns regarding the diagnostic feasibility of cognitive fusion in obese populations, where software-based fusion is strictly superior. Future prospective trials in both Asian and Western populations must evaluate the BMI effect as a primary end point.
TRIAL REGISTRATION: ClinicalTrials.gov NCT04271527.