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Avoiding unnecessary biopsy: the combination of PRIMARY score with prostate-specific antigen density for prostate biopsy decision

Prostate Cancer and Prostatic Diseases (2023)Cite this article

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Abstract

Background

Avoiding unnecessary biopsies for men with suspected prostate cancer remains a clinical priority. The recently proposed PRIMARY score improves diagnostic accuracy in detecting clinically significant prostate cancer (csPCa). The aim of this study was to determine the best strategy combining PRIMARY score or MRI reporting scores (Prostate Imaging Reporting and Data System [PI-RADS]) with prostate-specific antigen density (PSAD) for prostate biopsy decision making.

Methods

A retrospective analysis of 343 patients who underwent both 68Ga-PSMA PET/CT and MRI before prostate biopsy was performed. PSA was restricted to <20 ng/ml. Different biopsy strategies were developed and compared based on PRIMARY score or PI-RADS with PSAD thresholds. Decision curve analysis (DCA) was plotted to define the optimal biopsy strategy.

Results

The prevalence of csPCa was 41.1% (141/343). According to DCA, the strategies of PRIMARY score +PSAD (strategy #1, strategy #2, strategy #6) had a higher net benefit than the strategies of PI-RADS + PSAD at the risk threshold of 8–20%. The best diagnostic strategy was strategy #1 (PRIMARY score 4-5 or PSAD ≥ 0.20), which avoided 38.2% biopsy procedures while missed 9.2% of csPCa cases. From a clinical perspective, strategies with a lower risk of missing csPCa were strategy #2 (PRIMARY score ≥4 or PSAD ≥ 0.15), which avoided 28.6% biopsies while missed 5.7% of csPCa cases, or strategy #6 (PRIMARY score≥3 or PSAD ≥ 0.15), which avoided 20.7% biopsies while missed only 3.5% of csPCa cases. The limitations of the study were the retrospective single-center nature.

Conclusions

The combination of PRIMARY score +PSAD allows individualized decisions to avoid unnecessary biopsy, outperforming the strategies of PI-RADS + PSAD. Further prospective trials are needed to validate these findings.

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Fig. 1: Distribution of ISUP grade group by PRIMARY score suspicion levels and PSAD groups.
Fig. 2: Decision curve analysis assessing the net benefit of different biopsy strategies for clinically significant prostate cancer.

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Data availability

The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

Funding

This study was supported by the National Natural Science Foundation of China (No. 82173204; 82302244, 82220108004), the Innovation Capability Support Program of Shaanxi (2021TD-39), and the Clinical Research Project of AFMU (2021LC2111).

Author information

Author notes

  1. These authors contributed equally: Shikuan Guo, Jingliang Zhang, Yingmei Wang.

  2. These authors jointly supervised this work: Fei Kang, Jing Wang, Weijun Qin

Authors and Affiliations

  1. Department of Urology, Xijing Hospital, Fourth Military Medical University, 710032, Xi’an, China

    Shikuan Guo, Jingliang Zhang, Jianhua Jiao, Zeyu Li, Chaochao Cui, Jian Chen, Wenhui Yang, Shuaijun Ma, Peng Wu, Yuming Jing & Weijun Qin

  2. Department of Urology, No.988th Hospital of Joint Logistic Support Force of PLA, Zhengzhou, 450042, Henan, China

    Shikuan Guo

  3. Department of Pathology, Xijing Hospital, Fourth Military Medical University, 710032, Xi’an, China

    Yingmei Wang

  4. Institute of Medical Research, Northwestern Polytechnical University, 710032, Xi’an, China

    Weihong Wen

  5. Department of Nuclear Medicine, Xijing Hospital, Fourth Military Medical University, 710032, Xi’an, Shaanxi, China

    Fei Kang & Jing Wang

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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by SG, JZ, JJ, ZL, CC, JC and WY. In the perspective of Nuclear Medicine, FK and JW made the supervision, project administration, review of the manuscript. YW reviewed the pathological result of biopsies. In the perspective of urology, WQ, SM, PW, YJ and WW made the supervision, project administration, review of the manuscript. In addition, WQ and JZ offered the funding. The first draft of the manuscript was written by SG and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Weijun Qin.

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The authors declare no competing interests.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The institutional review board (Ethics Committees of Xijing Hospital, Fourth Military Medical University) approved this study and all subjects signed a written informed consent.

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Guo, S., Zhang, J., Wang, Y. et al. Avoiding unnecessary biopsy: the combination of PRIMARY score with prostate-specific antigen density for prostate biopsy decision. Prostate Cancer Prostatic Dis (2023). https://doi.org/10.1038/s41391-023-00782-z

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