Development and validation of multivariable biopsy-free nomograms to predict clinically significant prostate cancer in patients with prostate-specific antigen levels ≥20 ng/mL.

Background: Elevated prostate-specific antigen (PSA) levels often lead to prostate biopsies, which can result in overdiagnosis and complications, thereby increasing preoperative anxiety. This study aimed to develop and validate a novel biopsy-free diagnostic nomogram for accurate detection of clinically significant prostate cancer (csPCa) in patients with PSA levels ≥20 ng/mL.

Methods: The cohort of this retrospective analysis included patients with PSA levels ≥20 ng/mL who underwent evaluation including clinical variables, Prostate Imaging-Reporting and Data System (PI-RADS), prostate health index (PHI), and prostate-specific membrane antigen positron emission tomography-computed tomography (PSMA PET/CT). Nomogram performance was evaluated using the concordance index, calibration plot, decision curve analysis, and the area under the receiver operating characteristic curve (AUC).

Results: Of 684 patients, 478 and 206 were randomly assigned to the diagnostic and validation cohorts, respectively. Multivariable predictors of csPCa included age, PSA density, PI-RADS, location of suspicious lesion, %PSA variation ratio, and acute urinary retention. The foundational nomogram achieved AUCs of 0.930 and 0.911 for the training and validation sets, respectively. By integrating both PHI and PSMA maximum standardized uptake value (SUVmax), the diagnostic accuracy of the advanced nomogram improved significantly, with AUCs of 0.951 and 0.935 for the training and validation sets, respectively. Limitations included the lack of external validation and potential selection bias.

Conclusions: The biopsy-free nomogram presents a promising approach for accurate diagnosis of csPCa in patients with PSA levels ≥20 ng/mL. This non-invasive method can reduce unnecessary biopsies and enhance patient care by identifying those necessitating further evaluation and treatment.