What question did this study set out to answer?

This study aims to identify non-clinically significant prostate cancer and avoid unnecessary biopsies in patients with elevated PSA levels.

January 14, 2026Open Access

Avoiding unnecessary biopsy in suspicious prostate cancer using PRIMARY score ≤3 and PSAD ≤0.2 ng/mL/cm3: a real-world, dual-center study from China

Key Points

This study aims to identify non-clinically significant prostate cancer and avoid unnecessary biopsies in patients with elevated PSA levels.
Retrospective enrollment of patients from two centers
Utilized PSA testing, multiparametric imaging, and PET/CT
Assessed Prostate Imaging Reporting and Data System (PI-RADS) and PRIMARY scores
Employed ROC curves and diagnostic tests to determine efficacy
Validated findings in an external cohort.
PRIMARY score ≤3 and PSAD ≤0.2 achieved 100% specificity and positive predictive value for clinically significant prostate cancer
Avoided 54.1% of unnecessary biopsies with no missed clinically significant cases in the discovery cohort
External validation confirmed 100% specificity and avoided 69.6% of biopsies with no missed clinically significant cases.

Abstract

Background Among Chinese men with prostate-specific antigen (PSA) 4–20 ng/mL scheduled for biopsy, <20% harbor clinically significant prostate cancer (csPCa, International Society of Urological Pathology ISUP ≥2); most procedures target non-clinically significant prostate cancer (non-csPCa; ISUP <2) or benign prostatic hyperplasia (BPH). We tested whether prostate-specific membrane antigen (PSMA) positron-emission tomography/computed tomography (PET/CT) combined with multiparametric imaging and laboratory assays can accurately identify non-csPCa/BPH and safely reduce unnecessary biopsies. Materials and methods We retrospectively enrolled patients from two centers. In the discovery cohort, participants underwent PSA testing, mpMRI, and 68 Ga-PSMA-PET/CT, and were assessed for Prostate Imaging Reporting and Data System (PI-RADS) and PRIMARY scores. Receiver operating characteristic (ROC) curves, decision curve analysis, and diagnostic tests compared the efficacy of each indicator for non-csPCa/BPH and established the optimal strategy. The validation cohort independently verified this strategy. Results Discovery cohort ( n = 243): PRIMARY score area under the curve (AUC) 0.92 (95% confidence interval CI: 0.88–0.95); cutoff ≤3 provided 83.5% sensitivity and 90.9% specificity, outperforming PI-RADS ( P = 0.002), PSA density (PSAD), free/total PSA (f/tPSA), and total PSA (tPSA) (all P < 0.0001). Combined models: PRIMARY score + PI-RADS AUC 0.95 (0.92–0.97); PRIMARY + PSAD or + f/tPSA both 0.94. A strategy of PRIMARY score ≤3 plus PSAD ≤0.2 achieved 100% specificity and positive predictive value (PPV) for csPCa, sparing 54.1% of unnecessary biopsies with zero csPCa missed – superior to European Association of Urology (EAU)-recommended PI-RADS ≤2 + PSAD ≤0.2 (sensitivity 19.6%). External cohort ( n = 149) validated 100% specificity/PPV, avoiding 69.6% of biopsies while maintaining 0% csPCa miss rate. Conclusions In men with suspected prostate cancer (PSA 4–20 ng/mL or abnormal digital rectal examination), the combined criterion of PRIMARY score ≤3 and PSAD ≤0.2 ng/mL/cm 3 enabled pre-biopsy triage that safely avoided immediate diagnostic biopsy in more than 50% of patients ultimately found to harbor non-csPCa and BPH in our cohorts, while ensuring that no csPCa was missed. These findings require confirmation in larger prospective, multicenter studies before routine clinical implementation.

Avoiding unnecessary biopsy in suspicious prostate cancer using PRIMARY score ≤3 and PSAD ≤0.2 ng/mL/cm3: a real-world, dual-center study from China

Key Points

Abstract

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