Xofigo - Men whose bome metastases are causing no symptoms or only mild ones

[Paul Edwards]

Thanks to Chuck Maack for drawing our attention to the report of a recent presentation by Dr Oliver A Sartor who was the principal North American investigator for the clinical trial that led to the approval by the United States Food and Drug Administration (FDA) for radium 223 (brand name Xofigo).

 

In 2013 the FDA approved radium 223 for treatment for patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.

 

Dr Sartor said that determining whether or not a patient had symptoms of bone metastases could often be a grey area.   He considered the extent of bone metastases was more important than the presence of pain in determining whether to treat a patient with radium 223.  Dr Sartor was treating patients with metastatic castration-resistant prostate cancer who had a significant burden of bone-metastatic disease, even though they might not be considered symptomatic.

 

After nearly a year of clinical use, Dr Sartor said that the optimal setting for radium 223 appeared to be in combination with new hormonal therapies such as Abiraterone (Xytiga) and Enzalutamide (Xtandi).

 

At present a large multi-country Stage III clinical trial is about to start recruiting in Australia: Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms

 

 

Dr Sartor said large clinical trials would be needed before radium 223 could be considered for use on patients who did not have metastatic disease or were not castration-resistant.