Abstract
Background
Recent advancements in radiological imaging have raised the possibility of diagnosing prostate cancer (PCa) without biopsy; however, the safety, feasibility, and diagnostic accuracy of this approach require comprehensive evaluation. This study proposes and evaluates an initial decision-making algorithm using PSMA PET/CT and mpMRI for selecting candidates suitable for radical prostatectomy without prior biopsy (RP-WPB).
Methods
Patient enrollment was conducted strictly according to the prospectively established decision-making algorithm. Candidates for RP-WPB were required to fulfill four essential criteria: PSA > 4 ng/mL, PI-RADS score≥4, miPSMA score≥2, and co-positive lesions identified on mpMRI and PSMA PET/CT. Patients staged as cT3-4, cN1, or cM1 (solitary metastasis) underwent RP-WPB directly. For patients with stage cT2N0M0, PSA levels were further stratified: those with PSA ranging from 4 to 30 ng/mL were invited to participate in the prospective study, whereas individuals with PSA ≥ 30 ng/mL qualified for RP-WPB only if they satisfied additional conditions, including age≥75 years, PSA density (PSAD) ≥ 0.2 ng/mL/cm3, and willingness to undergo non-neurovascular-bundle-sparing surgery.
Results
From January 2022 to February 2024, 150 patients were prospectively enrolled following the algorithm; 30 patients withdrew, and 120 underwent RP-WPB. Among the latter, 84 patients were classified as cT2N0M0, 27 as cT3-4, 10 as cN1, and 9 as cM1. The detection rate of clinically significant PCa (csPCa) (ISUP grade ≥2) patients was 100% (95% CI: 0.97-1.00, p = 0.176), and pathological concordance was achieved in all cases. No perioperative complications greater than Clavien-Dindo grade Ⅱ occurred.
Conclusions
The proposed algorithm based on PSMA PET/CT and mpMRI for performing RP-WPB demonstrates safety, feasibility, and high diagnostic accuracy, presenting a promising option for selected PCa patients.
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Data availability
The datasets used and code that support the findings will be made available upon reasonable request via email to the corresponding author.
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Acknowledgements
The authors thank all the staff in the Department of Urology of The Third Medical Center of Chinese PLA General Hospital for their support during the study. We are also grateful to the reviewers for their constructive suggestions.
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Zhuoran Li, Jin Luo and Qiwei Liu were involved in the conceptualisation, data analysis and interpretation, manuscript drafting, and statistical analysis. Yuqi Jia, Zhiqiang Chen, Nanxin Zou, Jinqiao Li, Chao Wang, and Qiming Yang contributed to data acquisition. Xiaohui Ding, Yachao Liu, Xixi Wang, Honghao Xu, Baichuan Wang and Haiyi Wang assisted in data interpretation. Songliang Du, Shaoxi Niu, Weimin Ci and Baojun Wang contributed to critical revision of the manuscript for important intellectual content and supervision. Yujie Dong participated in statistical analysis and data visualisation. Baojun Wang was responsible for funding acquisition. Yundong Xuan, Zhuo Jia, and Songliang Du provided administrative, technical or material support. Xu Zhang, Shaoxi Niu, Songliang Du and Baojun Wang were responsible for overall supervision.
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Li, Z., Luo, J., Liu, Q. et al. Radical prostatectomy without prior biopsy: an initial decision-making algorithm based on PSMA PET/mpMRI. Prostate Cancer Prostatic Dis (2026). https://doi.org/10.1038/s41391-026-01081-z
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DOI: https://doi.org/10.1038/s41391-026-01081-z
