Skip to main content

Guidelines on Radioisotope Treatment of Bone Metastases in Prostate Cancer

  • Chapter
  • First Online:
Clinical Applications of Nuclear Medicine Targeted Therapy

Abstract

Radium-223 (Ra-223), strontium-89 (Sr-89), and samarium-153 (Sm-153) are radiopharmaceuticals approved in the United States and elsewhere for the treatment of painful skeletal metastases in select populations (Tables 30.1 and 30.2). The primary aim of this chapter is to provide a cohesive educational review of practice recommendations for these agents using guidelines from professional societies, prescribing information, and published observations.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Institutional subscriptions

References

  1. Bayer. Xofigo prescribing information. 2016 [cited 2017 May 27]. Available from: http://labeling.bayerhealthcare.com/html/products/pi/Xofigo_PI.pdf.

  2. GE. Metastron prescribing information. 2013 [cited 2017 May 27]. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=020134.

  3. Lantheus. Quadramet prescribing information. 2014. Available from: http://www.lantheus.com/products/overview/quadramet/.

  4. USNRC. Code of Federal Regulations, Title 10, Part 35 (10 CFR Part 35) – Medical use of byproduct material. 2017 [cited 2017 Jun 04]. Available from: https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/.

  5. Larson RH, Henriksen G, Bruland ØS. Preparation and use of radium-223 to target calcified tissues for pain palliation, bone cancer therapy, and bone surface conditioning. 2003: United States patent US6635234 B1.

    Google Scholar 

  6. Henriksen G, et al. Targeting of osseous sites with alpha-emitting 223Ra: comparison with the beta-emitter 89Sr in mice. J Nucl Med. 2003;44(2):252–9.

    CAS  PubMed  Google Scholar 

  7. Nilsson S, et al. First clinical experience with alpha-emitting radium-223 in the treatment of skeletal metastases. Clin Cancer Res. 2005;11(12):4451–9.

    Article  CAS  PubMed  Google Scholar 

  8. Carrasquillo JA, et al. Phase I pharmacokinetic and biodistribution study with escalating doses of (2)(2)(3)Ra-dichloride in men with castration-resistant metastatic prostate cancer. Eur J Nucl Med Mol Imaging. 2013;40(9):1384–93.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Abou DS, et al. Whole-body and microenvironmental localization of radium-223 in naive and mouse models of prostate cancer metastasis. J Natl Cancer Inst. 2016;108(5):djv380.

    Article  PubMed  Google Scholar 

  10. Frankenberg-Schwager M, Frankenberg D. Rejoining of radiation-induced DNA double-strand breaks in yeast. In: Obe G, editor. Advances in mutagenesis research. Berlin: Springer; 1991. p. 1–25.

    Google Scholar 

  11. Finlay IG, Mason MD, Shelley M. Radioisotopes for the palliation of metastatic bone cancer: a systematic review. Lancet Oncol. 2005;6(6):392–400.

    Article  CAS  PubMed  Google Scholar 

  12. Parker C, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369(3):213–23.

    Article  CAS  PubMed  Google Scholar 

  13. Saad F, et al. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016;17(9):1306–16.

    Article  CAS  PubMed  Google Scholar 

  14. Lowrance WT, et al. Castration-resistant prostate cancer: AUA guideline amendment 2015. J Urol. 2016;195(5):1444–52.

    Article  PubMed  Google Scholar 

  15. Shore ND. When to initiate treatment with radium-223 in patients with metastatic castration-resistant prostate cancer. Clin Adv Hematol Oncol. 2016;14(1):26–9.

    PubMed  Google Scholar 

  16. Modi D, et al. Radium-223 in heavily pretreated metastatic castrate-resistant prostate cancer. Clin Genitourin Cancer. 2016;14(5):373. e2–380.e2.

    Article  Google Scholar 

  17. Cornford P, et al. EAU-ESTRO-SIOG guidelines on prostate cancer. Part II: treatment of relapsing, metastatic, and castration-resistant prostate cancer. Eur Urol. 2017;71(4):630–42.

    Article  PubMed  Google Scholar 

  18. Baldari S, et al. Management of metastatic castration-resistant prostate cancer: A focus on radium-223: opinions and suggestions from an expert multidisciplinary panel. Crit Rev Oncol Hematol. 2017;113:43–51.

    Article  PubMed  Google Scholar 

  19. Umeweni N, Knight H, McVeigh G. NICE guidance on gadium-223 dichloride for hormone-relapsed prostate cancer with bone metastases. Lancet Oncol. 2016;17(3):275–6.

    Article  CAS  PubMed  Google Scholar 

  20. Crawford ED, et al. The role of therapeutic layering in optimizing treatment for patients with castration-resistant prostate cancer (prostate cancer radiographic assessments for detection of advanced recurrence II). Urology. 2017;104:150–9.

    Article  PubMed  Google Scholar 

  21. Bayer. Product Monograph Xofigo. Radium Ra 223 dichloride solution for injection. [Monograph] 2016 [cited 2017 Apr 02]. Available from: http://omr.bayer.ca/omr/online/xofigo-pm-en.pdf.

  22. NLM, ClinicalTrials.gov. 2017.

  23. Finkelstein S, et al. External beam radiation therapy (EBRT) use and safety with radium-223 dichloride (Ra-223) in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases (mets) from the ALSYMPCA trial. Int J Radiat Oncol Biol Phys. 2015;93(3):S20. [Abstract 1107].

    Article  Google Scholar 

  24. USNRC. Revision to the National Institute of Standards and Technology standard for radium-223 and impact on dose calibration for the medical use of radium-223 dichloride. 2016 [cited 2017 Jun 18]. Available from: https://www.nrc.gov/docs/ML1526/ML15264B095.pdf.

  25. Hague C, Logue JP. Clinical experience with radium-223 in the treatment of patients with advanced castrate-resistant prostate cancer and symptomatic bone metastases. Ther Adv Urol. 2016;8(3):175–80.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  26. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Prostate Cancer. Version 2.2017 2017 [cited 2017 Apr 02]. Available from: https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf.

  27. Dauer LT, et al. Radiation safety considerations for the use of (2)(2)(3)RaCl(2) DE in men with castration-resistant prostate cancer. Health Phys. 2014;106(4):494–504.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  28. Sartor O, et al. An exploratory analysis of alkaline phosphatase, lactate dehydrogenase, and prostate-specific antigen dynamics in the phase 3 ALSYMPCA trial with radium-223. Ann Oncol. 2017;28(5):1090–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  29. Benjegerdes KE, Brown SC, Housewright CD. Focal cutaneous squamous cell carcinoma following radium-223 extravasation. Proc (Bayl Univ Med Cent). 2017;30(1):78–9.

    Article  Google Scholar 

  30. Brady D, Parker CC, O’Sullivan JM. Bone-targeting radiopharmaceuticals including radium-223. Cancer J. 2013;19(1):71–8.

    Article  CAS  PubMed  Google Scholar 

  31. Jong JM, et al. Radiopharmaceuticals for palliation of bone pain in patients with castration-resistant prostate cancer metastatic to bone: a systematic review. Eur Urol. 2016;70(3):416–26.

    Article  PubMed  Google Scholar 

  32. Nilsson S, et al. A randomized, dose-response, multicenter phase II study of radium-223 chloride for the palliation of painful bone metastases in patients with castration-resistant prostate cancer. Eur J Cancer. 2012;48(5):678–86.

    Article  CAS  PubMed  Google Scholar 

  33. Preston DF, Dusing RW. Therapy for painful skeletal metastases. In: Henkin RE, editor. Nuclear medicine. Philadelphia: Mosby Elsevier; 2006.

    Google Scholar 

  34. Pandit-Taskar N, Batraki M, Divgi CR. Radiopharmaceutical therapy for palliation of bone pain from osseous metastases. J Nucl Med. 2004;45(8):1358–65.

    CAS  PubMed  Google Scholar 

  35. Nilsson S. Radionuclide therapies in prostate cancer: integrating radium-223 in the treatment of patients with metastatic castration-resistant prostate cancer. Curr Oncol Rep. 2016;18(2):14.

    Article  PubMed  PubMed Central  Google Scholar 

  36. Silberstein EB, et al. Society of Nuclear Medicine procedure guideline for palliative treatment of painful bone metastases. 2003 [cited 2017 May 27]. Available from: http://snmmi.files.cms-plus.com/docs/pg_ch25_0403.pdf.

  37. Henkin RE, et al. ACR-ASTRO practice guideline for the performance of therapy with unsealed radiopharmaceutical sources. Clin Nucl Med. 2011;36(8):e72–80.

    Article  PubMed  Google Scholar 

  38. UCSD. Radionuclide Data Sheets. 2017 [cited 2017 Jun 04]. Available from: https://blink.ucsd.edu/safety/radiation/research/RUA/radionuclide.html.

  39. Eary JF, et al. Samarium-153-EDTMP biodistribution and dosimetry estimation. J Nucl Med. 1993;34(7):1031–6.

    CAS  PubMed  Google Scholar 

  40. Tu SM, et al. Bone-targeted therapy for advanced androgen-independent carcinoma of the prostate: a randomised phase II trial. Lancet. 2001;357(9253):336–41.

    Article  CAS  PubMed  Google Scholar 

  41. Collins C, et al. Samarium-153-EDTMP in bone metastases of hormone refractory prostate carcinoma: a phase I/II trial. J Nucl Med. 1993;34(11):1839–44.

    CAS  PubMed  Google Scholar 

  42. Resche I, et al. A dose-controlled study of 153Sm-ethylenediaminetetramethylenephosphonate (EDTMP) in the treatment of patients with painful bone metastases. Eur J Cancer. 1997;33(10):1583–91.

    Article  CAS  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Laura Evangelista .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2018 Springer International Publishing AG, part of Springer Nature

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Murphy, R., Evangelista, L. (2018). Guidelines on Radioisotope Treatment of Bone Metastases in Prostate Cancer. In: Bombardieri, E., Seregni, E., Evangelista, L., Chiesa, C., Chiti, A. (eds) Clinical Applications of Nuclear Medicine Targeted Therapy . Springer, Cham. https://doi.org/10.1007/978-3-319-63067-0_30

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-63067-0_30

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-63066-3

  • Online ISBN: 978-3-319-63067-0

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics