Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases
| Autor: | Tsuyoshi Kawano, Tomohiro Kaneta, Kazuya Shizukuishi, Shoko Takano, Tomio Inoue, Ayako Hino, Christian Zurth, Keisuke Yoshida, Masato Kaneko, Madoka Sugiura, Tou Yamamoto |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Oncology
Male medicine.medical_specialty Bone Neoplasms Castration resistant Metastases Radiation Dosage 030218 nuclear medicine & medical imaging 03 medical and health sciences Prostate cancer 0302 clinical medicine Pharmacokinetics Radium-223 Internal medicine medicine Dosimetry Humans Radiology Nuclear Medicine and imaging Tissue Distribution Radium-223 Dichloride Radiometry Castration-resistant prostate cancer Aged Radioisotopes business.industry Radiotherapy Dosage General Medicine medicine.disease Phase i study Prostatic Neoplasms Castration-Resistant Radiology Nuclear Medicine and imaging 030220 oncology & carcinogenesis Original Article business Radium |
| Zdroj: | Annals of Nuclear Medicine |
| ISSN: | 1864-6433 0914-7187 |
| Popis: | Objective This open-label, non-randomized, phase I study examined the pharmacokinetics (PK) and radiation dosimetry of a single dose of radium-223 in Japanese patients with castration-resistant prostate cancer (CRPC) and bone metastases. Methods Six male Japanese patients (mean age 72.5 years, range 65–79 years) with histologically or cytologically confirmed stage IV adenocarcinoma of the prostate were recruited. A single IV dose of radium-223 was delivered intravenously (IV) via slow bolus over a 2–5 min period: Cohort 1 received 50 kBq/kg and Cohort 2 received 100 kBq/kg. Results Following IV injection, radium-223 was rapidly eliminated from the blood in a multi-phasic manner. The fraction of the injected activity of radium-223 retained in the whole body 24 h following injection was 85 %. Biodistribution results showed initial bone uptake was 52 % (range 41–57 %). The maximum activity of radium-223 in the bone was observed within 2 h of dosing. Activity of radium-223 passed through the small intestine within 24 h. No activity was detected in other organs. The major radiation dose from radium-223 was found in osteogenic cells; calculated absorbed doses in osteogenic cells and in the red marrow were 0.76 Gy/MBq and 0.09 Gy/MBq, respectively. Conclusions In Japanese patients with CRPC and bone metastases, radium-223 (IV) achieved maximum activity in the bone rapidly and passed through the intestine within 24 h, without signs of activity in other organs. The PK profile and absorbed radiation dose in organs and tissues in Japanese patients were similar to data from non-Japanese patients. Trial registration identification: NCT01565746. |
| Databáze: | OpenAIRE |
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