In a small trial using oral sodium clodronate, a bisphosphonate like Zometa and Fosamax, it was shown to extended prostate cancer survival by 23 percent (23%). The survival benefit was seen only when the drug was used in combination with hormone therapy in men with metastatic disease.
Many doctors have believed that bisphosphonates could have an effect on the eventual development of bone metastases in men with prostate cancer and effect their survival. To see if this theory could be verified the Medical Research Council (MRC) (UK) enrolled men into two randomized, controlled trials (PR05 and PR04) designed to evaluate the effects of sodium clodronate on disease progression and survival.
The studys (PR05 and PR04) were published in Lancet Oncology, in an article written by Dearnaley et al.
PR04 included 311 men, all who had confirmed metastatic disease, and 508 men with non-metastatic disease, most were being treated with radiation, hormone therapy (ADT) or with both treatment modalities.
PR05 included only men who had confirmed metastatic disease and were responding to hormone therapy.
In both trials, the men were randomly assigned either to receive 2,080 mg per day of sodium clodronate or to receive a placebo. Men with metastatic disease received either the drug or placebo for up to three years while men with out metastatic disease received their pills for up to five years.
The researchers were able to analyze data on 278 men with metastatic disease (PR05). They found that 93% (258/278) of the men had died after a median follow-up of 11.5 years. Those men who had received the sodium clodronate experienced a 23% overall survival benefit (hazard ratio 0.77; p=0.032) compared with those who received placebo.
In the trial PR04 with men with non-metastatic disease, the researchers were able to analyze data from 471 men without metastatic disease. Two hundred and eighty one (281) of the subjects had died after a medium follow-up time of twelve years. There was no difference in survival between the group of men who received the clodronate and the placebo control group (hazard ratio 1.12; p=0.94).
Conclusion- “Long-term data from these trials show that … sodium clodronate, improves overall survival in men with metastatic prostate cancer who are starting hormone therapy, but there is no evidence of an effect in men with non-metastatic prostate cancer.” – Dearnaley
This study clearly signals the need to study if the administration of other bisphosphonates, like Zometa and Fosamax as well as denosumab if it received FDA approval, to men with metastatic prostate cancer while on hormone therapy (ADT) will extend their life. In the mean time, if you do have metastatic disease and are on a protocol of ADT you should discuss with your doctor taking sodium clodronate to protect your bone density and extend your life.
Joel T Nowak MA, MSW