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
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 68Ga-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 +…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 243 participants or records.
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