A predictive model based on biparametric magnetic resonance imaging and clinical parameters for improved risk assessment and selection of biopsy-naive men for prostate biopsies

Background Prostate cancer risk prediction models and multiparametric magnetic resonance imaging (mpMRI) are used for individualised pre-biopsy risk assessment. However, biparametric MRI (bpMRI) has emerged as a simpler, more rapid MRI approach (fewer scan sequences, no intravenous contrast-media) to reduce costs and facilitate a more widespread clinical implementation. It is unknown how bpMRI and risk models perform conjointly. Therefore, the objective was to develop a predictive model for significant prostate cancer (sPCa) in biopsy-naive men based on bpMRI findings and clinical parameters. Methods Eight hundred and seventy-six biopsy-naive men with clinical suspicion of prostate cancer (prostate-specific antigen, <50 ng/mL; tumour stage,<T3) underwent pre-biopsy prostate bpMRI (T2-weighted and diffusion-weighted) followed by 10-core standard biopsies (all men) and MRI-transrectal ultrasound fusion targeted biopsies of bpMRI-suspicious lesions (suspicion score, >= 3) Prediction models based on bpMRI scores and clinical parameters (age, tumour stage, prostate-specific-antigen [PSA] level, prostate(volume), and PSA(density)) were created to detect sPCa (any biopsy-core with Gleason grade-group, >= 2) and compared by analysing the areas under the curves and decision curves. Results Overall, sPCa was detected in 350/876 men (40%) with median (inter-quartile range) age and PSA level of 65 years (60-70) and 7.3 ng/mL (5.5-10.6), respectively. The model defined by bpMRI scores, age, tumour stage, and PSA(density) had the highest discriminatory power (area under the curve, 0.89), showed good calibration on internal bootstrap validation, and resulted in the greatest net benefit on decision curve analysis. Applying a biopsy risk threshold of 20% meant that 42% of men could avoid a biopsy, 50% fewer insignificant cancers were diagnosed, and only 7% of significant cancers (grade-group, were missed. Conclusions A predictive model based on bpMRI scores and clinical parameters significantly improved risk stratification for sPCa in biopsy-naive men and could be used for clinical decision-making and counselling men prior to prostate biopsies.