Incorporation of trans-rectal color doppler flow imaging and risk-stratification nomogram reduce unnecessary prostate biopsies in suspected prostate cancer patients: a bi-centered retrospective validation study.

ABSTRACT

BACKGROUND: To explore the role of Trans-rectal Color Doppler Flow Imaging (TR-CDFI) and risk-stratification nomogram in a MRI-directed biopsy pathway and examine its clinical performance, via comparisons between existing four biopsy pathways. METHODS: A Bi-centered retrospective cohort study on biopsy-naïve male population who received ultrasound-guided prostate biopsy from Jan. 2015 to Feb. 2022 was proposed. All enrolled patients should have undergone serum-PSA test, TR-CDFI and multiparametric MRI before biopsy, and subsequently opted for surgical intervention, enabling more accurate pathological grading. We then utilized univariate and multivariate logistic regression analysis to construct a predictive nomogram for risk-stratification. Outcome measurements were overall prostate cancer (PCA) detection rate, clinically significant PCA (csPCA) detection rate, clinically insignificant PCA (cisPCA) detection rate, biopsy avoidance rate and missed csPCA detection rate. Decision curve analysis was used to compare the performances between diagnostic pathways. RESULTS: Under the criteria mentioned above, 752 patients from two centers were included. Reference pathway (biopsy for all) showed that overall PCA detection rate was 46.1%, csPCA and cisPCA detection rates were 32.3% and 13.8% respectively. Risk-based MRI-directed TR-CDFI pathway, which incorporated both TR-CDFI and risk stratification nomogram, exhibited PCA detection rate of 38.7%, csPCA detection rate of 28.7%, cisPCA detection rate of 7.0%, Biopsy avoidance rate of 42.4%, and missed csPCA detection rate of 3.6%. Decision curve analysis revealed that the risk-based pathway held the most net benefit, under the threshold probability level between 0.1 and 0.5. CONCLUSIONS: The risk-based MRI-directed TR-CDFI pathway out-performed other strategies, balancing csPCA detection and biopsy avoidance. This suggested that incorporation of TR-CDFI and risk-stratification nomogram in the early PCA diagnostic procedures could reduce unnecessary biopsies.