ArticleAnnals of nuclear medicine2016
Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases.
Article in Annals of nuclear medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01565746 (Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases), which is not on this map. Cited by 29 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases
Who cites it
29 citing papers in PubMed.
- RADTHYR: an open-label, single-arm, prospective multicenter phase II trial of Radium-223 for the treatment of bone metastases from radioactive iodine refractory differentiated thyroid cancer.European journal of nuclear medicine and molecular imaging · 2021Trial
- Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer.International journal of clinical oncology · 2018Trial
- Effect of intratumoral alpha radiation on tumor growth delay and tumor microenvironment in an orthotopic colorectal liver metastasis murine model.Scientific reports · 2026Article
- Biokinetic modelling of the exhalation ofRadiation and environmental biophysics · 2026Article
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- Clinical application of targeted α-emitter therapy in gastroenteropancreatic neuroendocrine neoplasms.Journal of gastroenterology · 2025Review
- Establishment of a practical methodology for evaluating equieffective dose of individual patients based on RT-PHITS.EJNMMI physics · 2025Article
- Exhalation of Rn-219 by patients treated with Radium-223.EJNMMI physics · 2025Article
- ISIT-QA: In Silico Imaging Trial to Evaluate a Low-Count Quantitative SPECT Method Across Multiple Scanner-Collimator Configurations forJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024Article
- Radiation safety considerations for the use of radium-224-calciumcarbonate-microparticles in patients with peritoneal metastasis.Frontiers in medicine · 2023Article
- Heterogeneity of dose distribution in normal tissues in case of radiopharmaceutical therapy with alpha-emitting radionuclides.Radiation and environmental biophysics · 2022Review
- Radiation Safety Considerations and Clinical Advantages of α-Emitting Therapy Radionuclides.Journal of nuclear medicine technology · 2022Article
- Alpha-Emitter Radiopharmaceuticals and External Beam Radiotherapy: A Radiobiological Model for the Combined Treatment.Cancers · 2022Article
- Comparing absorbed doses and radiation risk of the α-emitting bone-seekers [Frontiers in medicine · 2022Review
- Imaging and dosimetry for alpha-particle emitter radiopharmaceutical therapy: improving radiopharmaceutical therapy by looking into the black box.European journal of nuclear medicine and molecular imaging · 2021Review
- The role of dosimetry and biological effects in metastatic castration-resistant prostate cancer (mCRPC) patients treated withJournal of experimental & clinical cancer research : CR · 2021Article
- Radiopharmacokinetic modelling and radiation dose assessment ofEJNMMI physics · 2021Article
- Practical considerations for quantitative clinical SPECT/CT imaging of alpha particle emitting radioisotopes.Theranostics · 2021Article
- Radium-223 dichloride causes transient changes in natural killer cell population and cytotoxic function.International journal of radiation biology · 2021Article
- Estimation of the lower limits for feasible Ra-223 SPECT imaging: a Monte Carlo simulation study.Asia Oceania journal of nuclear medicine & biology · 2021Article
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11 authors.
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No grant is acknowledged in the PubMed record.
Abstract
objectiveThis 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.
methodsSix 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.
resultsFollowing 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.
conclusionsIn 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.
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