Background: Precise risk stratification through MRI/US fusion-guided targeted biopsy (TBx) can guide optimal prostate cancer (PCa) management. Objective: The purpose of this study was to compare PI-RADS version 2. 0 (v2.0) and PI-RADS version 2.1 (v2.1) in terms of the rates of International Society of Urological Pathology (ISUP) grade group (GG) upgrade and down grade from TBx to radical prostatectomy (RP). Methods: This study entailed a retrospective post-hoc analysis of patients who underwent 3-T prostate MRI at a single institution from May 2015 to March 2023 as part of prospective clinical trials. From the trial participants, those who underwent MRI followed by MRI/ultrasound-fusion guided TBx and RP within a 1-year interval were identified. A single genitourinary radiologist performed clinical interpretations of the MRI examinations using PI-RADS v2.0 from May 2015 to March 2019, and using PI-RADS v2.1 from April 2019 to March 2023. Upgrade and downgrade rates from TBx to RP were compared using chi-square tests. Clinically significant cancer was defined as GG ≥2. Results: The final analysis included 308 patients (median age, 65 years; median PSA density, 0.16 ng/mL2). The v2.0 group (n=177) and v2.1 group (n=131) showed no significant difference in terms of upgrade rate (29% vs 22%, p=.15), downgrade rate (19% vs 21%, p=.76), clinically significant upgrade rate (14% vs 10%, p=.27) or clinically significant downgrade rate (1% vs 1%, p>.99). The upgrade rate and downgrade rate were also not significantly different between the v2.0 and v2.1 groups when stratifying by index lesion PI-RADS category or index lesion zone, as well as when assessed only in patients without a prior PCa diagnosis (all p>.01). Among patients with GG2 or GG3 at RP (n=121 for v2.0; n=103 for v2.1), the concordance rate between TBx and RP was not significantly different between the v2.0 and v2.1 groups (53% vs 57%, p=.51). Conclusion: Upgrade and downgrade rates from TBx to RP were not significantly different between patients whose MRI examinations were clinically interpreted using v2.0 or v2.1. Clinical Impact: Implementation of the most recent PI-RADS update did not improve the incongruence in PCa grade assessment between Tbx and surgery.
AJR. American journal of roentgenology. 2023 Sep 20 [Epub ahead of print]
Enis C Yilmaz, Yue Lin, Mason J Belue, Stephanie A Harmon, Tim E Phelps, Katie M Merriman, Lindsey A Hazen, Charisse Garcia, Latrice Johnson, Nathan S Lay, Antoun Toubaji, Maria J Merino, Krishnan R Patel, Howard L Parnes, Yan Mee Law, Bradford J Wood, Sandeep Gurram, Peter L Choyke, Peter A Pinto, Baris Turkbey
Molecular Imaging Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD., Center for Interventional Oncology, National Cancer Institute, National, Institutes of Health, Bethesda, Maryland., Laboratory of Pathology, National Cancer Institute, National Institutes of Health, Bethesda, Maryland., Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland., Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland., Department of Radiology, Singapore General Hospital, Singapore., Urologic Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.