PI-RADS v2 is a Strong Prognostic Marker for Adverse Outcomes in Prostate Cancer
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Importance
Magnetic Resonance Imaging (MRI) coupled with Prostate Imaging-Reporting and Data System (PI-RADS) provides a standardized scoring system for assessing clinical significance of prostate cancer (PCa). However, the association between PI-RADS scores and key clinical end-points remains underexplored due to limited follow-up data.
Objective
To evaluate the association of PI-RADS with prostate cancer-specific mortality (PCSM), overall survival (OS), metastasis-free survival (MFS), and biochemical recurrence (BCR) across multiple cohorts.
Design, Setting, Participants
A retrospective registry cohort was collected from Helsinki University Hospital (HUS) for men with clinical suspicion of PCa. HUS cohort included 4,674 men who underwent diagnostic MRI during the PI-RADS version 2 era (2015-2019, median follow-up [mFU] 5.0 years). Validation cohorts were gathered from Tampere University Hospital (n=1,474, 2016-2021, mFU 2.2 years) and Lille University Hospital (N=301, 2016-2024, mFU 6.2 years).
Exposures
Diagnostic MRI imaging was scored using PI-RADS v2.
Main outcomes and measures
Primary outcomes were PCSM, OS, MFS, and BCR. Secondary measures included clinical confounders, such as age, Grade Group (GG), and Charlson’s Comorbidity Index (CCI).
Results
In the HUS cohort, 84 of 4,674 patients (1.7%) died of PCa, with 79 patients (94%) presenting with PI-RADS score 5. In multivariable Cox regression adjusted for clinical confounders, PI-RADS score 5 was significantly associated with PCSM (Hazard Ratio (HR) 18.4, 95% CI [6.62-51.1], p<0.001), along with biopsy GG 5 (HR 5.45 [1.82-16.3], p=0.002), CCI (HR 1.53 [1.42-1.7], p<0.001), and log2-PSA (HR 1.28 [1.11-1.5], p<0.001). Kaplan-Meier curves demonstrated negligible PCSM after negative MRI (PI-RADS score 0-2) (log-rank p<0.001). PI-RADS score 5 was associated with OS in both the Helsinki and Tampere cohorts (p<0.001) and MFS and BCR in the Lille cohort (p<0.001).
Conclusion and relevance
PI-RADS score 5 is strongly associated with an increased risk of PCSM and other clinically relevant outcomes. Conversely, a non-suspicious MRI presents a negligible risk of adverse outcomes. These findings support the use of MRI for risk stratification in PCa.
