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Radium 223 Alpharadin for men with CRPC


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Radium 223 for the treatment of patients with symptomatic castrate resistant prostate cancer with skeletal metastases

Assessment No


Application Name

Radium 223 for the treatment of patients with symptomatic castrate resistant prostate cancer with skeletal metastases

Assessment Type

Submission based assessment

Description Of Medical Service

Radium 223, which is an injection, is an alpha emitting pharmaceutical (alpha-pharmaceutical). This product naturally targets bone metastases due to its calcium-mimicking properties. The bone targeting property of radium-223 is similar to that of other earth alkaline elements, like strontium-89. However, the radiation characteristics of an alpha-particle emitting radionuclide seem to be more advantageous than a beta-emitting radionuclide. Radium-223, with a physical half-life of 11.4 days, emits high linear energy transfer alpha radiation, with a range limited to less than 100 micrometers, and can thus be used to generate localised radiation zones. An alpha-emitting radiation source located in a target tissue, such as skeletal metastases, will deliver the radiation to a more localised volume, thereby reducing exposure of surrounding normal tissues.

Description Of Medical Condition

Prostate cancer cell growth is stimulated by male hormones (androgens), in particular testosterone and its metabolite dihydro-testosterone. Therefore, patients may be treated by androgen deprivation to reduce levels of male hormones available to cancer cells. Androgen deprivation can be achieved surgically (castration), or medically using hormone therapy. 

Unfortunately, patients ultimately stop responding to hormone therapy and are then referred to as having hormone-refractory or androgen-independent prostate cancer. 

The most common site of cancer spread in men with hormone refractory prostate cancer is bone. Development of bone metastases is a major problem in prostate cancer and is a serious threat to a patient’s survival and quality of life. Untreated patients face severe morbidity, including bone pain, bone fracture, compression of the spinal cord and haematological consequences of bone marrow involvement. If treated successfully, these symptoms may be palliated and patients may also gain a survival benefit.

Pre Assessment Meeting

7 December 2011

Stage 2 – Suitability for Assessment

11 January 2012

Proposed DAP Received

12 January 2012

Stage 3 - 1st PASC 

(Draft DAP considered)

12-13 April 2012

Stage 3 – Release for Public Comment

(Consultation DAP)

28 May - 5 July 2012

Consultation Decision Analytic Protocol (DAP) - PDF

Consultation Decision Analytic Protocol (DAP) - Accessible Word version

Stage 3 - 2nd PASC

(Final DAP)

16-17 August 2012

PDF version - Final Decision Analytic Protocol (updated) (PDF 1158 KB)

Word version - Final Decision Analytic Protocol (updated) (Word 681 KB)

Stage 4 - Submission of Collated Evidence

To be advised by Applicant

Stage 5 - ESC evaluation


Stage 6 - MSAC Appraisal


Stage 6 - MSAC advice


Stage 7 - Noting by Minister


Stage 8 - Implementation



Page currency, Latest update: 12 November, 2013

Alpharadin or Radium 223 was approved by the FDA (US Food and Drug Administration) on 15 May 2013 for the treatment of bone metastases of men with CRPC (Castration Resistant Prostate Cancer).

The Trademark name of this new drug is Xofigo.


The chart above shows just how far behind we can be in the approval process in this country compared to the USA.


There are two links below where Dr Myers talks on the use of this new form of treatment.


28 January 2014




28 May 2013



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