Fast Biparametric Versus Multiparametric Magnetic Resonance Imaging for Triage of Men with Elevated Prostate-specific Antigen: The PRO-TRIAGE Prospective Comparative Trial.

Abstract

Background and objective: The increasing demand for prostate magnetic resonance imaging (MRI) underscores the need for better accessibility. We conducted a prospective study to compare fast biparametric MRI (fast-bpMRI) with multiparametric MRI (mpMRI) in terms of the number of men requiring biopsy and the detection rate for clinically significant prostate cancer (csPC).

Methods: From May 2021 to December 2023, fast-bpMRI and mpMRI scans for 364 men were randomly assigned at a 1:1 ratio to two different readers for evaluation using Prostate Imaging-Reporting and Data System (PI-RADS) version 2.1. A third researcher who was unaware of the MRI protocol used reviewed the readers' report to identify MRI-suspicious lesions (PI-RADS ≥3) and performed biopsy. The primary outcome was the proportion of men requiring biopsy. Secondary outcomes were the proportion of equivocal cases (PI-RADS 3), csPC detection rates (Gleason score ≥ 3 + 4), and diagnostic performance for csPC detection. The PRO-TRIAGE study was registered on cris.nih.go.kr as KCT0006181.

Key findings and limitations: The number of men requiring biopsy for MRI-suspicious lesions (PI-RADS ≥3) was 195 (53.6%) according to fast-bpMRI and 185 (50.8%) according to mpMRI (p = 0.28). Equivocal cases (PI-RADS 3) were observed in 65 men (17.9%) according to fast-bpMRI and 58 (15.9%) according to mpMRI (p = 0.46). The csPC detection rate was 26.4% for both protocols. Using PI-RADS ≥3 as a cutoff, the sensitivity for csPC detection was 92.8% with fast-bpMRI and 90.7% with mpMRI (p = 0.41), while the specificity was 53.8% with fast-bpMRI and 56.7% with mpMRI (p = 0.52).

Conclusions and clinical implications: Fast-bpMRI resulted in a slightly higher proportion of men requiring biopsy in comparison to mpMRI, with a comparable csPC detection rate.