Li Yujia, Yang Jinhui, Xiao Ling, Zhou Ming, Li Jian, Cai Yi, Gao Xiaomei, Rominger Axel, Shi Kuangyu, Seifert Robert, Su Qi, Tang Yongxiang, Hu Shuo
Department of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Department of Urology, Disorders of Prostate Cancer Multidisciplinary Team, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Eur J Nucl Med Mol Imaging. 2025 May;52(6):2051-2062. doi: 10.1007/s00259-025-07089-2. Epub 2025 Jan 25.
This study aimed to identify if a subset of men can safely avoid or delay prostate biopsy based on negative results of prostate-specific membrane antigen positron emission tomography (PSMA-PET).
Among 341 consecutive cases in a prospective biopsy cohort (NCT05073653), 111 treatment-naïve men with negative PSMA-PET (PRIMARY-score 1/2) were included. All participants underwent PSMA-PET and histopathological examinations. Clinically significant prostate cancer (csPCa) was defined as Grade Group ≥ 2. Multivariate logistic regression was employed to identify predictors of non-csPCa. Receiver operating characteristic (ROC) analysis was performed to detect non-csPCa on prostate pathology. PSMA-postive patients were additionally reviewed to assess the imaging and pathological outcomes.
Younger age was identified as an independent predictor (P = 0.006) for the absence of csPCa. ROC analysis of csPCa revealed the largest areas under the curve of 0.77 (0.67-0.87) and 0.78 (0.68-0.88) for individual age in the entire PSMA-negative cohort and the MRI subset, respectively (both P < 0.001). The negative predictive value (NPV) of PSMA-PET for csPCa detection improved with a decreasing age, from 88% in all, to 98% in men aged under 65 yrs (98% vs. 88%, P = 0.021), and to 100% in men aged under 60 yrs (100% vs. 88%, P = 0.040). The NPV of PSMA-PET improved from 88 to 94% when combined with negative MRI, and to 100% in men with negative MRI and aged under 65 yrs. The prevalence was 57% for csPCa and 65% for PCa of any grade.
We preliminarily propose that omission or postponement of prostate biopsy should be considered for men under the age of 65 yrs with negative PSMA-PET scored as PRIMARY 1 or 2. Conversely, prostate biopsy might be considered in biopsy-naïve men aged 65 yrs or older with strong clinical suspicion of PCa, despite negative PSMA-PET. Further prospective and external evaluation is needed to prove the robustness of this novel strategy.
本研究旨在确定是否有一部分男性能够基于前列腺特异性膜抗原正电子发射断层扫描（PSMA-PET）的阴性结果安全地避免或推迟前列腺活检。
在前瞻性活检队列（NCT05073653）的341例连续病例中，纳入了111例未经治疗且PSMA-PET结果为阴性（PRIMARY评分1/2）的男性。所有参与者均接受了PSMA-PET和组织病理学检查。临床显著性前列腺癌（csPCa）定义为分级组≥2级。采用多因素逻辑回归分析来确定非csPCa的预测因素。进行受试者操作特征（ROC）分析以检测前列腺病理检查中的非csPCa。对PSMA阳性患者进行额外评估以评估影像学和病理结果。
年龄较小被确定为无csPCa的独立预测因素（P = 0.006）。对csPCa的ROC分析显示，在整个PSMA阴性队列和MRI亚组中，个体年龄的曲线下面积分别最大为0.77（0.67 - 0.87）和0.78（0.68 - 0.88）（均P < 0.001）。PSMA-PET检测csPCa的阴性预测值（NPV）随着年龄的降低而提高，从总体的88%提高到65岁以下男性的98%（98%对88%，P = 0.021），以及60岁以下男性的100%（100%对88%，P = 0.040）。当与MRI阴性结果相结合时，PSMA-PET的NPV从88%提高到94%，在MRI阴性且年龄在65岁以下的男性中提高到100%。csPCa的患病率为57%，任何分级的前列腺癌患病率为65%。
我们初步建议，对于PSMA-PET评分PRIMARY为1或2且结果为阴性的65岁以下男性，应考虑省略或推迟前列腺活检。相反，对于65岁及以上、临床高度怀疑前列腺癌但PSMA-PET结果为阴性的未经活检男性，可能需要考虑进行前列腺活检。需要进一步的前瞻性和外部评估来证实这一新颖策略的稳健性。
