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

Q: Why was biopsy avoidance considered in suspected prostate cancer patients with PSA 4–20 ng/mL?

Because most patients scheduled for biopsy do not have clinically significant prostate cancer, procedures often target non-clinically significant cancer or benign prostatic hyperplasia.

Q: What strategy did the study test to triage patients before biopsy?

The study tested a combined criterion of PRIMARY score ≤3 and PSAD ≤0.2 ng/mL/cm3, using PSMA PET/CT with multiparametric imaging and laboratory assays to identify non-csPCa/BPH.

Q: What diagnostic performance did the PRIMARY ≤3 and PSAD ≤0.2 approach achieve?

It provided 100% specificity and positive predictive value for csPCa in the discovery cohort, avoiding 54.1% of unnecessary biopsies with zero csPCa missed; external validation maintained 0% csPCa miss rate.

Sep 23, 2026

Uploaded by Riley West

Among Chinese men with PSA 4–20 ng/mL scheduled for biopsy, fewer than 20% harbor clinically significant prostate cancer (csPCa). This study evaluated whether PSMA PET/CT combined with multiparametric imaging and laboratory assays can distinguish non-csPCa or benign prostatic hyperplasia (BPH) to safely reduce unnecessary biopsies. In a retrospective two-center design, a PRIMARY score cutoff ≤3 plus PSAD ≤0.2 ng/mL/cm3 achieved 100% specificity/PPV for csPCa and spared over half of biopsies without csPCa misses; external validation confirmed results, pending prospective confirmation.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

AccessFree to download

Background

Materials and methods

Results

Conclusions

Keywords

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 Jiawei He, MDa , Lin Qi, MD, PhDa , Minfeng Chen, MD, PhDa , Shuo Hu, MD, PhDb , Xiaomei Gao, MD, PhDc ,*, Yongxiang Tang, MD, PhDb ,*, Shouzhen Chen, MD, PhDd ,*, Yi Cai, MD, PhDa ,* 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 + 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/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. Keywords: PI-RADS score, PRIMARY score, prostate cancer, prostate-specific antigen density aDepartment of Urology, Disorders of Prostate Cancer Multidisciplinary Team, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China, bDepartment of PET Center, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China, cDepartment of Pathology, Disorders of Prostate Cancer Multidisciplinary Team, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China and dDepartment of Urology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article. *Corresponding authors. Address: Department of Pathology, Disorders of Prostate Cancer Multidisciplinary Team, National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, China. Tel.: +86 13667371031. E-mail: [lswindy-2012@163.com](lswindy-2012@163.com) (X. Gao); Department of PET Center, National Clinical Resear

FAQs

Why was biopsy avoidance considered in suspected prostate cancer patients with PSA 4–20 ng/mL?

Because most patients scheduled for biopsy do not have clinically significant prostate cancer, procedures often target non-clinically significant cancer or benign prostatic hyperplasia.

What strategy did the study test to triage patients before biopsy?

The study tested a combined criterion of PRIMARY score ≤3 and PSAD ≤0.2 ng/mL/cm3, using PSMA PET/CT with multiparametric imaging and laboratory assays to identify non-csPCa/BPH.

What diagnostic performance did the PRIMARY ≤3 and PSAD ≤0.2 approach achieve?

It provided 100% specificity and positive predictive value for csPCa in the discovery cohort, avoiding 54.1% of unnecessary biopsies with zero csPCa missed; external validation maintained 0% csPCa miss rate.

Sep 23, 2026

Uploaded by Riley West