{"title":"68Ga-PSMA-11 PET/CT 评估：针对日本原发性、复发性或疑似复发性前列腺癌患者的 1 期临床研究。","authors":"Anri Inaki, Atsushi Mizokami, Hiroshi Wakabayashi, Kouji Izumi, Yoshifumi Kadono, Tadashi Toyama, Shizuko Takahara, Toshinori Murayama, Seigo Kinuya","doi":"10.1007/s12149-024-01931-7","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Prostate-specific membrane antigen (PSMA)-targeted radiopharmaceuticals allow whole-body imaging to detect prostate cancer (PC). Positron emission tomography imaging using gallium-68 (<sup>68</sup>Ga)-PSMA-11 has been shown to have a favorable safety and tolerability profile and high diagnostic performance. The study evaluates the safety and pharmacokinetics of <sup>68</sup>Ga-PSMA-11 in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer.</p><h3>Methods</h3><p>This single arm study enrolled Japanese patients with primary PC (<i>n</i> = 3), suspected recurrent PC following radical prostatectomy (<i>n</i> = 4), or suspected recurrent PC following radical radiotherapy (<i>n</i> = 3). All patients received a single intravenous dose of <sup>68</sup>Ga-PSMA-11 2.0 MBq/kg (±10%) followed by PSMA PET imaging and safety and pharmacokinetic evaluations. Based on the blood concentrations of <sup>68</sup>Ga-PSMA-11 and the radioactivity distribution rate in each organ/tissue, the absorbed doses in major organs/tissues and the whole-body effective dose were calculated by the Medical Internal Radiation Dose method.</p><h3>Results</h3><p>Ten patients were enrolled. Mean age was 73.3 ± 4.8 years, and median prostate-specific antigen was 8.250 ng/mL. Five patients (50%) experienced a total of 6 adverse events, and no grade ≥ 2 adverse events or serious adverse events were reported. No clinically significant changes in vital signs, haematology parameters, or blood chemistry or ECG abnormalities were observed. The estimated whole body effective dose of <sup>68</sup>Ga-PSMA-11 (mean ± standard deviation) was 2.524 × 10<sup>–2</sup> ± 2.546 × 10<sup>–3</sup> mSv/MBq. Time to maximum concentration (1.16 × 10<sup>–4</sup> ± 1.3 × 10<sup>–5</sup>% ID/mL) in whole blood was 2.15 ± 0.33 min.</p><h3>Conclusions</h3><p><sup>68</sup>Ga-PSMA-11 has a favourable safety and tolerability profile in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer, which is comparable to previous observations in other populations.</p></div>","PeriodicalId":8007,"journal":{"name":"Annals of Nuclear Medicine","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2024-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11281955/pdf/","citationCount":"0","resultStr":"{\"title\":\"Evaluation of 68Ga-PSMA-11 PET/CT: a Phase 1 clinical study in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer\",\"authors\":\"Anri Inaki, Atsushi Mizokami, Hiroshi Wakabayashi, Kouji Izumi, Yoshifumi Kadono, Tadashi Toyama, Shizuko Takahara, Toshinori Murayama, Seigo Kinuya\",\"doi\":\"10.1007/s12149-024-01931-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Prostate-specific membrane antigen (PSMA)-targeted radiopharmaceuticals allow whole-body imaging to detect prostate cancer (PC). Positron emission tomography imaging using gallium-68 (<sup>68</sup>Ga)-PSMA-11 has been shown to have a favorable safety and tolerability profile and high diagnostic performance. The study evaluates the safety and pharmacokinetics of <sup>68</sup>Ga-PSMA-11 in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer.</p><h3>Methods</h3><p>This single arm study enrolled Japanese patients with primary PC (<i>n</i> = 3), suspected recurrent PC following radical prostatectomy (<i>n</i> = 4), or suspected recurrent PC following radical radiotherapy (<i>n</i> = 3). All patients received a single intravenous dose of <sup>68</sup>Ga-PSMA-11 2.0 MBq/kg (±10%) followed by PSMA PET imaging and safety and pharmacokinetic evaluations. Based on the blood concentrations of <sup>68</sup>Ga-PSMA-11 and the radioactivity distribution rate in each organ/tissue, the absorbed doses in major organs/tissues and the whole-body effective dose were calculated by the Medical Internal Radiation Dose method.</p><h3>Results</h3><p>Ten patients were enrolled. Mean age was 73.3 ± 4.8 years, and median prostate-specific antigen was 8.250 ng/mL. Five patients (50%) experienced a total of 6 adverse events, and no grade ≥ 2 adverse events or serious adverse events were reported. No clinically significant changes in vital signs, haematology parameters, or blood chemistry or ECG abnormalities were observed. The estimated whole body effective dose of <sup>68</sup>Ga-PSMA-11 (mean ± standard deviation) was 2.524 × 10<sup>–2</sup> ± 2.546 × 10<sup>–3</sup> mSv/MBq. Time to maximum concentration (1.16 × 10<sup>–4</sup> ± 1.3 × 10<sup>–5</sup>% ID/mL) in whole blood was 2.15 ± 0.33 min.</p><h3>Conclusions</h3><p><sup>68</sup>Ga-PSMA-11 has a favourable safety and tolerability profile in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer, which is comparable to previous observations in other populations.</p></div>\",\"PeriodicalId\":8007,\"journal\":{\"name\":\"Annals of Nuclear Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2024-05-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11281955/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Nuclear Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s12149-024-01931-7\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Nuclear Medicine","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1007/s12149-024-01931-7","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
Evaluation of 68Ga-PSMA-11 PET/CT: a Phase 1 clinical study in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer
Background
Prostate-specific membrane antigen (PSMA)-targeted radiopharmaceuticals allow whole-body imaging to detect prostate cancer (PC). Positron emission tomography imaging using gallium-68 (68Ga)-PSMA-11 has been shown to have a favorable safety and tolerability profile and high diagnostic performance. The study evaluates the safety and pharmacokinetics of 68Ga-PSMA-11 in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer.
Methods
This single arm study enrolled Japanese patients with primary PC (n = 3), suspected recurrent PC following radical prostatectomy (n = 4), or suspected recurrent PC following radical radiotherapy (n = 3). All patients received a single intravenous dose of 68Ga-PSMA-11 2.0 MBq/kg (±10%) followed by PSMA PET imaging and safety and pharmacokinetic evaluations. Based on the blood concentrations of 68Ga-PSMA-11 and the radioactivity distribution rate in each organ/tissue, the absorbed doses in major organs/tissues and the whole-body effective dose were calculated by the Medical Internal Radiation Dose method.
Results
Ten patients were enrolled. Mean age was 73.3 ± 4.8 years, and median prostate-specific antigen was 8.250 ng/mL. Five patients (50%) experienced a total of 6 adverse events, and no grade ≥ 2 adverse events or serious adverse events were reported. No clinically significant changes in vital signs, haematology parameters, or blood chemistry or ECG abnormalities were observed. The estimated whole body effective dose of 68Ga-PSMA-11 (mean ± standard deviation) was 2.524 × 10–2 ± 2.546 × 10–3 mSv/MBq. Time to maximum concentration (1.16 × 10–4 ± 1.3 × 10–5% ID/mL) in whole blood was 2.15 ± 0.33 min.
Conclusions
68Ga-PSMA-11 has a favourable safety and tolerability profile in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer, which is comparable to previous observations in other populations.
期刊介绍：
Annals of Nuclear Medicine is an official journal of the Japanese Society of Nuclear Medicine. It develops the appropriate application of radioactive substances and stable nuclides in the field of medicine.
The journal promotes the exchange of ideas and information and research in nuclear medicine and includes the medical application of radionuclides and related subjects. It presents original articles, short communications, reviews and letters to the editor.
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