First-in-human Study of a Dual-modality Prostate-specific Membrane Antigen–targeted Probe for Preoperative Positron Emission Tomography/Computed Tomography Imaging and Intraoperative Fluorescence Imaging in Prostate Cancer

IF 25.3 1区医学 Q1 UROLOGY & NEPHROLOGY

European urology Pub Date : 2025-04-09 DOI:10.1016/j.eururo.2025.03.010

Silu Chen, Hongchuang Xu, Xueqi Chen, Qi Shen, Xu Chen, Meng Zhang, Zhihua Li, Zhongyuan Zhang, Han Hao, Wei Yu, Yan Fan, Liqun Zhou, Ning Zhang, Jianhua Zhang, Xing Yang, Cheng Shen, Xuesong Li

{"title":"First-in-human Study of a Dual-modality Prostate-specific Membrane Antigen–targeted Probe for Preoperative Positron Emission Tomography/Computed Tomography Imaging and Intraoperative Fluorescence Imaging in Prostate Cancer","authors":"Silu Chen, Hongchuang Xu, Xueqi Chen, Qi Shen, Xu Chen, Meng Zhang, Zhihua Li, Zhongyuan Zhang, Han Hao, Wei Yu, Yan Fan, Liqun Zhou, Ning Zhang, Jianhua Zhang, Xing Yang, Cheng Shen, Xuesong Li","doi":"10.1016/j.eururo.2025.03.010","DOIUrl":null,"url":null,"abstract":"<h3>Background and objective</h3>Accurately distinguishing between cancerous and noncancerous tissues during robot-assisted radical prostatectomy (RARP) is a challenge that can increase the risk of residual disease. This study aimed to evaluate the safety, optimal dose and accuracy of a dual-modality prostate-specific membrane antigen (PSMA)-targeted probe (<sup>68</sup>Ga-P3) for preoperative positron emission tomography (PET)/computed tomography (CT) imaging and intraoperative fluorescence imaging in prostate cancer.<h3>Methods and surgical procedure</h3>Each participant received an intravenous chemical dose of <sup>68</sup>Ga-P3 (10, 20, and 40 μg/kg), with radioactivity of 3.7 MBq/kg. PET/CT imaging was conducted 30, 60, and 120 min after injection to evaluate its biodistribution and dosimetry. RARP was performed at 24 ± 6 h after injection, in the sensitive mode of Firefly fluorescence imaging.<h3>Key findings and limitations</h3>Between May 2024 and July 2024, a total of 16 patients were included; <sup>68</sup>Ga-P3 was well tolerated without any adverse events related to <sup>68</sup>Ga-P3 administration or fluorescence imaging. At 2 h after administration, the median tumor maximum standardized uptake value was 5.3 (4.1–8.1). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of <sup>68</sup>Ga-P3 PET/CT for tumor localization were 79.1%, 90.4%, 81.5%, and 89.0%, respectively. The overall NPV, PPV, and accuracy of intraoperative fluorescence imaging were 100%, 43.8%, and 90.9%, respectively. Of overall false-positive sites, 88.9% (8/9) were confirmed as tumor adjacent to the surgical margin. A dose of 40 μg/kg resulted in the highest accuracy of 92.3%.<h3>Conclusions and clinical implications</h3>In PSMA-targeted PET imaging and fluorescence-guided surgery, <sup>68</sup>Ga-P3 is safe and feasible for use, offering a novel tool for the surgical management of prostate cancer.","PeriodicalId":12223,"journal":{"name":"European urology","volume":"25 1","pages":""},"PeriodicalIF":25.3000,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European urology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.eururo.2025.03.010","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background and objective

Accurately distinguishing between cancerous and noncancerous tissues during robot-assisted radical prostatectomy (RARP) is a challenge that can increase the risk of residual disease. This study aimed to evaluate the safety, optimal dose and accuracy of a dual-modality prostate-specific membrane antigen (PSMA)-targeted probe (⁶⁸Ga-P3) for preoperative positron emission tomography (PET)/computed tomography (CT) imaging and intraoperative fluorescence imaging in prostate cancer.

Methods and surgical procedure

Each participant received an intravenous chemical dose of ⁶⁸Ga-P3 (10, 20, and 40 μg/kg), with radioactivity of 3.7 MBq/kg. PET/CT imaging was conducted 30, 60, and 120 min after injection to evaluate its biodistribution and dosimetry. RARP was performed at 24 ± 6 h after injection, in the sensitive mode of Firefly fluorescence imaging.

Key findings and limitations

Between May 2024 and July 2024, a total of 16 patients were included; ⁶⁸Ga-P3 was well tolerated without any adverse events related to ⁶⁸Ga-P3 administration or fluorescence imaging. At 2 h after administration, the median tumor maximum standardized uptake value was 5.3 (4.1–8.1). The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of ⁶⁸Ga-P3 PET/CT for tumor localization were 79.1%, 90.4%, 81.5%, and 89.0%, respectively. The overall NPV, PPV, and accuracy of intraoperative fluorescence imaging were 100%, 43.8%, and 90.9%, respectively. Of overall false-positive sites, 88.9% (8/9) were confirmed as tumor adjacent to the surgical margin. A dose of 40 μg/kg resulted in the highest accuracy of 92.3%.

Conclusions and clinical implications

In PSMA-targeted PET imaging and fluorescence-guided surgery, ⁶⁸Ga-P3 is safe and feasible for use, offering a novel tool for the surgical management of prostate cancer.

查看原文本刊更多论文

求助全文

约1分钟内获得全文求助全文

来源期刊

European urology 医学-泌尿学与肾脏学

CiteScore

43.00

自引率

2.60%

发文量

1753

审稿时长

23 days

期刊介绍： European Urology is a peer-reviewed journal that publishes original articles and reviews on a broad spectrum of urological issues. Covering topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, the journal also highlights recent advances in techniques, instrumentation, surgery, and pediatric urology. This comprehensive approach provides readers with an in-depth guide to international developments in urology.