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Background <p>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).</p> Methods <p>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 &gt; 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/cm<sup>3</sup>, and willingness to undergo non-neurovascular-bundle-sparing surgery.</p> Results <p>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, <i>p</i> = 0.176), and pathological concordance was achieved in all cases. No perioperative complications greater than Clavien-Dindo grade Ⅱ occurred.</p> Conclusions <p>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.</p>

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Radical prostatectomy without prior biopsy: an initial decision-making algorithm based on PSMA PET/mpMRI

  • 期刊论文

  • 发表日期：

    2026年1月31日

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  • Zhuoran Li,
  • Jin Luo,
  • Qiwei Liu,
  • Yuqi Jia,
  • Zhiqiang Chen,
  • Nanxin Zou,
  • Jinqiao Li,
  • Yujie Dong,
  • Qiming Yang,
  • Chao Wang,
  • Zhuo Jia,
  • Yundong Xuan,
  • Xiaohui Ding,
  • Honghao Xu,
  • Baichuan Liu,
  • Xixi Wang,
  • Haiyi Wang,
  • Yachao Liu,
  • Xu Zhang,
  • Weimin Ci,
  • Shaoxi Niu,
  • Songliang Du,
  • Baojun Wang

摘要

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.