Evaluation of 68Ga-PSMA-11 PET/CT: a Phase 1 clinical study in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer

IF 2.5 4区 医学 Q2 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING
Anri Inaki, Atsushi Mizokami, Hiroshi Wakabayashi, Kouji Izumi, Yoshifumi Kadono, Tadashi Toyama, Shizuko Takahara, Toshinori Murayama, Seigo Kinuya
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引用次数: 0

Abstract

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.

Abstract Image

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。
背景:前列腺特异性膜抗原(PSMA)靶向放射性药物可通过全身成像检测前列腺癌(PC)。使用镓-68 (68Ga)-PSMA-11进行的正电子发射断层成像已被证明具有良好的安全性、耐受性和诊断性能。该研究评估了68Ga-PSMA-11在日本原发性、复发性或疑似复发性前列腺癌患者中的安全性和药代动力学:这项单臂研究招募了原发性前列腺癌(3 例)、根治性前列腺切除术后疑似复发性前列腺癌(4 例)或根治性放疗后疑似复发性前列腺癌(3 例)的日本患者。所有患者均接受单次静脉注射 68Ga-PSMA-11 2.0 MBq/kg(±10%),然后进行 PSMA PET 成像以及安全性和药代动力学评估。根据 68Ga-PSMA-11 的血药浓度和各器官/组织的放射性分布率,采用医用内照射剂量法计算主要器官/组织的吸收剂量和全身有效剂量:结果:共收治 10 名患者。平均年龄(73.3±4.8)岁,前列腺特异性抗原中位数为 8.250 纳克/毫升。5名患者(50%)共出现6次不良反应,无≥2级不良反应或严重不良反应报告。未发现生命体征、血液学参数、血液生化指标或心电图异常等有临床意义的变化。68Ga-PSMA-11的估计全身有效剂量(平均值±标准偏差)为2.524 × 10-2 ± 2.546 × 10-3 mSv/MBq。全血中达到最大浓度(1.16 × 10-4 ± 1.3 × 10-5% ID/mL)的时间为 2.15 ± 0.33 分钟:68Ga-PSMA-11在日本原发性、复发性或疑似复发性前列腺癌患者中具有良好的安全性和耐受性,与之前在其他人群中观察到的结果相当。
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来源期刊
Annals of Nuclear Medicine
Annals of Nuclear Medicine 医学-核医学
CiteScore
4.90
自引率
7.70%
发文量
111
审稿时长
4-8 weeks
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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