1268 - The use of Radium-223, for the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases
|
Assessment No | 1268 |
| Application Name | Radium-223 for the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases |
| 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 Final Decision Analytic Protocol (DAP) - PDF Final Decision Analytic Protocol (DAP) - Accessible Word version |
| 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: 03 May, 2013
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