Background: Urologists face a dilemma when deciding whether prostate biopsy is required for patients with prostate-specific antigen (PSA) levels in the grey zone (4 to 10 ng/mL).
Methods:We retrospectively analyzed data from consecutive patients with PSA levels in grey zone, who underwent targeted multiparametric magnetic resonance imaging (MP-MRI)/transrectal ultrasound (TRUS) fusion biopsy with elastography between November 2017 and December 2019 in our hospital. The patientse data including age, PSA, fPSA (free PSA), fPSA/PSA, PSA density (PSAD), prostate volume, elastography Q-analysis score (EQS), and prostate imaging-reporting and data system (PI-RADS) score were collected. The nomogram was built using logistic regression and the final cohort of patients was randomly divided into a training cohort (70%) and a validation cohort (30%) by R software. The models were evaluated by receiver operating characteristic curve (ROC) analysis and calibration curve analysis. The nomogram was constructed from the best model. Results: The final study cohort consisted of 155 patients (training cohort, 109 patients; validation cohort, 46 patients) with PSA in the grey zone, of which 36 patients were pathologically diagnosed with PCa. The EQS model, −EQS model, +EQS model were built. The +EQS model that consisted of fPSA/PSA, EQS, and PI-RADS score had the best PCa diagnostic accuracy (development and validation, 0.783 and 0.781) and probability score (development and validation, 0.939 vs. 0.622). The new nomogram based on this model was constructed, in which fPSA/PSA ratio had the largest impact, followed by PI-RADS and EQS.Conclusions: Elastography and pre-biopsy MP-MRI has clinical significance for patients with PSA in the grey zone. The new nomogram, which is based on pre biopsy data including serological analysis, PI-RADS score, and EQS, can be helpful for clinical decision-making to avoid unnecessary biopsy.