New Prostate Cancer treatment for New Zealand

Posted by on 19 Feb 2012 in News | 0 comments

Thanks to the results of one of the prostate cancer trials Canterbury Urology Research Trust have been involved in, the U.S. Food and Drug Administration (FDA) has approved a new drug, Denosumab for use in prevention of skeletal-related events in patients with bone metastases. This makes Denosumab the first RANKL inhibitor to be approved by the FDA, and is now available for use in New Zealand.

Denosumab, developed by AMGEN, is a human antibody which can be used for the treatment of osteoporosis, treatment induced bone loss, bone metastases, rheumatoid arthritis and more. Administered as a simple monthly injection, it binds to and inhibits the body’s bone removal protein – RANKL. In many bone loss conditions, RANKL overwhelms the body’s natural defence against bone destruction. By inhibiting RANKL, Denosumab protects bone from degradation and slows the progression of these conditions.

For men with prostate cancer, bone loss is not only caused by the cancer but also prostate cancer treatments, which lower the levels of hormones that maintain bone density. Canterbury Urology Research Trust have run three clinical research studies with AMGEN to date, all looking at the treatment effect of Denosumab in men with prostate cancer. 38 men from Canterbury have been screened and 24 randomised to take part in the international studies sponsored by AMGEN, ranging from stable prostate cancer through to men with more advanced disease including bone metastases.

After reviewing safety and efficacy data from 30 clinical studies involving more than 12,000 patients using Denosumab, the recommendation was made for the approval of Denosumab for the treatment of postmenopausal osteoporosis and for the treatment of bone loss in patients undergoing hormone ablation for prostate cancer.

The expected time on the AMGEN studies can range from 12 months to 5-6 years. Participants generally find this a very positive experience with regular clinic visits to see their Urologist and research nurse, including careful monitoring of their condition and general well-being.