Radiation safety considerations for the use of ²²³RaCl₂ DE in men with castration-resistant prostate cancer.

Abstract:

:The majority of patients with late stage castration-resistant prostate cancer (CRPC) develop bone metastases that often result in significant bone pain. Therapeutic palliation strategies can delay or prevent skeletal complications and may prolong survival. An alpha-particle based therapy, radium-223 dichloride (²²³RaCl₂), has been developed that delivers highly localized effects in target areas and likely reduces toxicity to adjacent healthy tissue, particularly bone marrow. Radiation safety aspects were evaluated for a single comprehensive cancer center clinical phase 1, open-label, single ascending-dose study for three cohorts at 50, 100, or 200 kBq kg⁻¹ body weight. Ten patients received administrations, and six patients completed the study with 1 y follow-up. Dose rates from patients administered ²²³Ra dichloride were typically less than 2 μSv h⁻¹ MBq⁻¹ on contact and averaged 0.02 μSv h⁻¹ MBq⁻¹ at 1 m immediately following administration. Removal was primarily by fecal excretion, and whole body effective half-lives were highly dependent upon fecal compartment transfer, ranging from 2.5-11.4 d. Radium-223 is safe and straightforward to administer using conventional nuclear medicine equipment. For this clinical study, few radiation protection limitations were recommended post-therapy based on facility evaluations. Specific precautions are dependent on local regulatory authority guidance. Subsequent studies have demonstrated significantly improved overall survival and very low toxicity, suggesting that ²²³Ra may provide a new standard of care for patients with CRPC and bone metastases.

journal_name

Health Phys

journal_title

Health physics

authors

Dauer LT,Williamson MJ,Humm J,O'Donoghue J,Ghani R,Awadallah R,Carrasquillo J,Pandit-Taskar N,Aksnes AK,Biggin C,Reinton V,Morris M,St Germain J

doi

10.1097/HP.0b013e3182a82b37

subject

Has Abstract

pub_date

2014-04-01 00:00:00

pages

494-504

issue

4

eissn

0017-9078

issn

1538-5159

pii

00004032-201404000-00006

journal_volume

106

pub_type

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