Pharmacokinetics and Dosimetry of [68Ga]Ga-PSMA-11 in Chinese Participants with Progressive Metastatic Castration-Resistant Prostate Cancer: A Phase 2 Study.
Wei Fan, Yonghong Li, Hongcheng Shi, Jianming Guo, Rui Huang, Qiang Dong, Zhi Yang, Yong Yang, Xinlu Wang, Di Gu, Dingwei Ye, Feng Wang, Jing Wang, Danfeng Xu, Zhiqiang Jiang, Haifu Li, Jialu Li, Runqin Li, Li Huo, Zhigang Ji
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引用次数: 0
Abstract
Introduction: [68Ga]Ga-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging has demonstrated clinical value for individuals with prostate cancer (PC). In this phase 2 study, we measured the pharmacokinetics and dosimetry of [68Ga]Ga-PSMA-11 in Chinese participants.
Methods: Adult Chinese participants with progressive metastatic castration-resistant PC (mCRPC) received a single intravenous [68Ga]Ga-PSMA-11 dose of approximately 150 MBq. Blood samples were collected at 5, 15, 30, 45, 85, 175, and 245 min post injection for pharmacokinetics assessments. Whole-body PET scans and low/ultra-low-dose CT scans were acquired at 30, 60, 120, and 255 min post injection for dosimetry assessments.
Results: Pharmacokinetics and dosimetry assessments were completed in seven participants who received a [68Ga]Ga-PSMA-11 dose (range: 108.3-236.7 MBq). In the blood, the geometric mean effective terminal half-life was 1.34 h (geometric coefficient of variation [geo-CV], 182%); geometric mean clearance was 9.80 L/h (geo-CV, 106%). The highest absorbed doses were seen in the kidneys, urinary bladder walls, and lacrimal glands. In the study population, the geometric mean (geo-CV) effective dose of [68Ga]Ga-PSMA-11 was 4.2 mSv (32.9%).
Conclusions: The pharmacokinetic and dosimetry profiles of [68Ga]Ga-PSMA-11, assessed using a validated method in participants with progressive mCRPC, make it very suitable with proves its suitability.
期刊介绍：
Cancer Biotherapy and Radiopharmaceuticals is the established peer-reviewed journal, with over 25 years of cutting-edge content on innovative therapeutic investigations to ultimately improve cancer management. It is the only journal with the specific focus of cancer biotherapy and is inclusive of monoclonal antibodies, cytokine therapy, cancer gene therapy, cell-based therapies, and other forms of immunotherapies.
The Journal includes extensive reporting on advancements in radioimmunotherapy, and the use of radiopharmaceuticals and radiolabeled peptides for the development of new cancer treatments.
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