ArticleInternational journal of surgery (London, England)2026
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.
Article in International journal of surgery (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Recent Advances in Multimodal Assessment Scoring Systems for Prostate Cancer: An Integrated Pathological and Imaging Perspective.Diagnostics (Basel, Switzerland) · 2026Review
- Diagnostic value of PRIMARY score and a combined model with SUVmax in 18F-PSMA-1007 PET/CT for prostate cancer.Frontiers in medicine · 2026Article
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8 authors.
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Abstract
backgroundAmong 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
methodsWe 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.
resultsDiscovery 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.
conclusionsIn 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/cm3 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.
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