Cancer biotherapy & radiopharmaceuticals · 2026
Pharmacokinetics and Dosimetry of [68Ga]Ga-PSMA-11 in Chinese Participants with Progressive Metastatic Castration-Resistant Prostate Cancer: A Phase 2 Study.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Fan Wei, Li Yonghong, Shi Hongcheng, Guo Jianming, Huang Rui, Dong Qiang, Yang Zhi, Yang Yong, Wang Xinlu, Gu Di, Ye Dingwei, Wang Feng, Wang Jing, Xu Danfeng, Jiang Zhiqiang, Li Haifu, Li Jialu, Li Runqin, Huo Li, Ji Zhigang
Аннотация
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.
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.