Application Detail

Status

Closed

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.

Reason for Application

-

Medical Service Type

-

Previous Application Number

Not Applicable

Associated Documentation

Application Form

-

PICO Confirmation

16-17 August 2012
Final Decision Analytic Protocol (updated) (PDF 1158 KB)
Final Decision Analytic Protocol (updated) (Word 681 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 226 KB)
Public Summary Document (Word 458 KB)

Meetings for this Application

PASC

12 – 13 April 2012
16 – 17 August 2012

ESC

13 – 14 February 2014

MSAC

3 – 4 April 2014