Noninferiority of Monoparametric MRI Versus Multiparametric MRI for the Detection of Prostate Cancer

The aim of this study was to compare the diagnostic accuracy of apparent diffusion coefficient (ADC) ratios as a monoparametric magnetic resonance imaging (MRI) protocol for the detection of prostate cancer (PCa) with the established multiparametric (mp) MRI at 3.0 T.According to power analysis, 52 male patients were included in this monocenter study with prospective data collection and retrospective, blinded multireader image analysis. The study was approved by the local ethics committee. Patients were recruited from January to December 2020. Based on mpMRI findings, patients underwent in-bore MR biopsy or prostatectomy for histopathologic correlation of suspicious lesions. Three readers, blinded to the histopathologic results and images of mpMRI, independently evaluated ADC maps for the detection of PCa. The ADC ratio was defined as the lowest signal intensity (SI) of lesions divided by the SI of normal tissue in the zone of origin. Predictive accuracy of multiparametric and monoparametric MRI were compared using logistic regression analysis. Moreover, both protocols were compared applying goodness-of-fit analysis with the Hosmer-Lemeshow test for continuous ADC ratios and Pearson χ2 test for binary decision calls, correlation analysis with Spearman ρ and intraclass correlation coefficients, as well as noninferiority assessment with a TOST ("two one-sided test").Eighty-one histopathologically proven, unique PCa lesions (Gleason score [GS] ≥ 3 + 3) in 52 patients could be unequivocally correlated, with 57 clinically significant (cs) PCa lesions (GS ≥ 3 + 4). Multiparametric MRI detected 95%, and monoparametric ADC detected ratios 91% to 93% of csPCa. Noninferiority of monoparametric MRI was confirmed by TOST (P < 0.05 for all comparisons). Logistic regression analysis revealed comparable predictive diagnostic accuracy of ADC ratios (73.7%-87.8%) versus mpMRI (72.2%-84.7%). Spearman rank correlation coefficient for PCa aggressiveness revealed satisfactory correlation of ADC ratios (P < 0.013 for all correlations). The Hosmer-Lemeshow test for the logistic regression analysis for continuous ADC ratios indicated adequate predictive accuracy (P = 0.55-0.87), and the Pearson χ2 test showed satisfactory goodness of fit (P = 0.35-0.69, χ2 = 0.16-0.87).Normalized ADC ratios based on advanced DWI are noninferior to mpMRI at 3.0 T for the detection of csPCa in a preselected patient cohort and proved a fast and accurate assessment tool, thus showing a potential prospect of easing the development of future screening methods for PCa.