PRECISE Assessment of Sequential Biparametric MRI and Clinically Significant Prostate Cancer in Biopsy-naive Men: A Retrospective Cohort Study

Background In real-world practice, some biopsy-naive men with suspected prostate cancer (PCa) defer immediate biopsy and undergo magnetic resonance imaging (MRI) follow-up, yet standardized criteria to interpret MRI changes are lacking. Objective To evaluate the association of the Prostate Cancer Radiological Estimation of Change in Sequential Evaluation (PRECISE) assessment of sequential biparametric MRI with clinically significant PCa (csPCa) at subsequent biopsy. Design, setting, and participants This retrospective single-center study included 174 biopsy-naive men who underwent at least two prebiopsy MRI examinations separated by ≥12 mo between 2019 and 2025. Two blinded radiologists assigned the Prostate Imaging Reporting and Data System (PI-RADS) categories and scored interval change using PRECISE version 2. All patients underwent prostate biopsy. Outcome measurements and statistical analysis The primary outcome was csPCa at subsequent biopsy, defined as International Society of Urological Pathology grade group ≥2. Multivariable Firth penalized logistic regression assessed factors associated with csPCa. Results and limitations Biopsy showed no PCa in 81 of the 174 (47%) men, clinically insignificant PCa in 20 of the 174 (12%) men, and csPCa in 73 of the 174 (42%) men. The csPCa rates increased with PRECISE: 6.1% (PRECISE 2/3-NonV), 26% (3-V), and 81% (4–5). After adjustment, the natural log of repeat prostate-specific antigen density (PSAD; odds ratio [OR] 2.14, 95% confidence interval [CI] = 1.10–4.44) and PRECISE 4–5 versus 2/3-NonV (OR 15.21, 95% CI = 2.97–104.44) remained associated with csPCa. Exploratory analysis showed that integrating baseline PI-RADS assessment with longitudinal MRI changes was associated with different observed rates of csPCa detection. Limitations include retrospective single-center design and sample size. Conclusions Sequential PRECISE assessment and repeat PSAD were associated with csPCa; prospective validation is required.