Department of Nuclear Medicine, Kanazawa University Hospital, 13-1 Takara-Machi, Kanazawa-Shi, Ishikawa, 920-8641, Japan.
Department of Integrative Cancer Therapy and Urology, Kanazawa University Hospital, 13-1 Takara-Machi, Kanazawa-Shi, Ishikawa, 920-8641, Japan.
Ann Nucl Med. 2024 Aug;38(8):587-595. doi: 10.1007/s12149-024-01931-7. Epub 2024 May 16.
Prostate-specific membrane antigen (PSMA)-targeted radiopharmaceuticals allow whole-body imaging to detect prostate cancer (PC). Positron emission tomography imaging using gallium-68 (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 Ga-PSMA-11 in Japanese patients with primary, recurrent, or suspected recurrent prostate cancer.
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 Ga-PSMA-11 2.0 MBq/kg (±10%) followed by PSMA PET imaging and safety and pharmacokinetic evaluations. Based on the blood concentrations of 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.
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 Ga-PSMA-11 (mean ± standard deviation) was 2.524 × 10 ± 2.546 × 10 mSv/MBq. Time to maximum concentration (1.16 × 10 ± 1.3 × 10% ID/mL) in whole blood was 2.15 ± 0.33 min.
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.
前列腺特异性膜抗原（PSMA）靶向放射性药物可全身成像以检测前列腺癌（PC）。已证明使用镓-68（Ga）-PSMA-11 的正电子发射断层扫描成像具有良好的安全性和耐受性以及较高的诊断性能。本研究评估了 Ga-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。
这项单臂研究纳入了日本原发性 PC 患者（n=3）、根治性前列腺切除术后疑似复发性 PC 患者（n=4）或根治性放疗后疑似复发性 PC 患者（n=3）。所有患者均接受单次静脉注射 2.0 MBq/kg（±10%）Ga-PSMA-11 治疗，随后进行 PSMA PET 成像和安全性及药代动力学评估。基于 Ga-PSMA-11 的血药浓度和各器官/组织的放射性分布率，采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。
共纳入 10 例患者。平均年龄为 73.3±4.8 岁，中位前列腺特异性抗原为 8.250ng/mL。5 例（50%）患者共发生 6 例不良事件，无≥2 级不良事件或严重不良事件报告。未观察到生命体征、血液学参数、血液化学或心电图异常的临床显著变化。Ga-PSMA-11 的估算全身有效剂量（平均值±标准差）为 2.524×10±2.546×10 mSv/MBq。全血达最大浓度时间（1.16×10±1.3×10% ID/mL）为 2.15±0.33 min。
Ga-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，与其他人群的先前观察结果相当。
