RANKL is blocked by denosumab, which is shown to be superior to zoledronic acid.
This study included CRPC patients and the goal was to assess prevention of bone metastasis with the primary endpoint being bone metastasis-free survival. It was randomized, double blind, placebo-controlled trial with 716 patients in each arm. All participants had a PSA>8ng/ml or PSADT<10 months. 7% had prior chemotherapy and many discontinued due to the development of bone metastasis (34-41%). A total of 164-174 remained in each arm. Denosumab increased bone metastasis-free survival by 4.2 months with an HR =0.85. Time to first bone metastasis increased by 3.7 months. Time to first symptomatic bone metastasis was also increased with an HR 0.69. Progression-free survival was better, HR 0.89. There were higher ASE’s with 4.6% having hypocalcemia and 1.7% having osteonecrosis of the jaw.
This is the first study to demonstrate that targeting the bone microenvironment delays onset of bone metastasis in men with prostate cancer.
Presented by Matthew R. Smith, MD, PhD at the American Urological Association (AUA) Annual Meeting - May 14 - 19, 2011 - Walter E. Washington Convention Center, Washington, DC USA
Reported for UroToday by Christopher P. Evans, MD, FACS, Professor and Chairman, Department of Urology, University of California, Davis, School of Medicine.