Radiation safety considerations for the use of (223)RaCl(2) de in men with castration-resistant prostate cancer Journal Article

   


Authors: Dauer, L. T.; Williamson, M. J.; Humm, J.; O'Donoghue, J.; Ghani, R.; Awadallah, R.; Carrasquillo, J.; Pandit-Taskar, N.; Aksnes, A. K.; Biggin, C.; Reinton, V.; Morris, M.; St. Germain, J.
Article Title: Radiation safety considerations for the use of (223)RaCl(2) 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 (RaCl2), 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 Ra 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 Ra may provide a new standard of care for patients with CRPC and bone metastases. Copyright © 2014 Health Physics Society. Unauthorized reproduction of this article is prohibited.
Keywords: treatment outcome; aged; aged, 80 and over; bone neoplasms; middle aged; bone tumor; antineoplastic agents; methodology; antineoplastic agent; radiopharmaceuticals; metastasis; body weight; pathology; radiation response; time; time factors; dose-response relationship, radiation; chemistry; bone; neoplasm metastasis; radiopharmaceutical agent; nuclear medicine; bone and bones; phase 1 clinical trial; radioisotope; radioisotopes; radiation protection; castration resistant prostate cancer; chloride; alpha radiation; alpha particles; chlorides; radium; very elderly; radium chloride ra 223; humans; human; male; article; radiation alpha; prostatic neoplasms, castration-resistant
Journal Title: Health Physics
Volume: 106
Issue: 4
ISSN: 0017-9078
Publisher: Lippincott Williams & Wilkins  
Date Published: 2014-04-01
Start Page: 494
End Page: 504
Language: English
DOI: 10.1097/HP.0b013e3182a82b37
PROVIDER: scopus
PUBMED: 24562070
PMCID: PMC4981573
DOI/URL:

http://www.scopus.com/inward/record.url?eid=2-s2.0-84896839244&partnerID=40&md5=a9b6decd27846e968225a6b53b11ee94
Notes: Export Date: 2 April 2014 -- CODEN: HLTPA -- Source: Scopus
Altmetric
What is Altmetric?
Citation Impact
What is Dimensions Citation Badge?
BMJ Impact Analytics
MSK Authors
  1. Michael Morris
    577 Morris
  2. Rashid Ghani
    3 Ghani
  3. Neeta Pandit-Taskar
    342 Pandit-Taskar
  4. Joseph O'Donoghue
    151 O'Donoghue
  5. John Laurence Humm
    433 Humm
  6. Jorge Carrasquillo
    140 Carrasquillo
  7. Lawrence Dauer
    170 Dauer
  8. Jean M St Germain
    61 St Germain
  9. Matthew Williamson
    27 Williamson
  10. Robert Awadallah
    1 Awadallah
Related MSK Work