A Clinical Trial has shown that the early use of Zoledronic Acid (Zometa) in men with castration sensitive prostate cancer does not provide any benefit.
Zoledronic Acid (Zometa) decreases a man’s risk of developing skeletal-related events (SREs) in men with castration-resistant advanced prostate cancer (CRPC) who also had bone metastases.
A phase III study evaluated the efficacy and safety of the earlier use of Zometa in men with advanced prostate cancer. who were still castration sensitive.
The study showed that using Zometa in men with castrate sensitive prostate cancer did not lower their risk of developing SREs or extend their life.
This trial (CALGB 90202) was a randomized, double-blinded, placebo-controlled phase III trial in men with castration-sensitive prostate cancer and bone metastases who had initiated androgen deprivation therapy within six months of study entry. The men were randomized 1:1 in a blinded manner to receive Zometa (4 mg intravenously every 4 weeks) or placebo. Once the men progressed and became castrate resistant (CRPC) they crossed over to receive Zometa.
The primary endpoint of the trial was time to the development of the first SRE. After 470 SRE events, the study was discontinued when the corporate supporter withdrew the study drug supply.
Analysis of the collected data between June 2004 and April 2012 included 645 men who were randomly assigned to Zometa or placebo. Median time to first SRE was 32.5 months in the Zometa group and 29.8 months in the placebo group.
A total of 271 deaths were observed; median follow-up time for surviving patients was 24.4 months. Overall survival was similar between both the study and the placebo groups.
The data concluded that men with castration-sensitive prostate cancer the early use of zoledronic acid did not provide them with any benefits. The early termination of the study limited the statistical power of the study.
J Clin Oncol 31, 2013 (suppl 6; abstract 27): Matthew Raymond Smith, etal.
Clinical trial information: NCT00079001.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and Appendiceal Cancer a rare cancer.