The results of a Phase III clinical research trial conducted by Lawrence Karsh, M.D., F.A.C.S., Clinical Research Director at The Urology Center of Colorado (TUCC), and 13 other researchers around the world have been published in the medical journal The Lancet. This particular study shows that a new drug, denosumab (XGEVA), is better than the current treatment standard of zoledronic acid (Zometa) for delaying and preventing adverse bone events in men with hormone resistant prostate cancer.
It is estimated that as many as three out of four men with advanced prostate cancer will experience bone metastases. Patients with bone metastases are at a greater risk of bone fractures and other adverse events that significantly limit their quality of life. Denosumab is a human monoclonal antibody (stimulating an immune response) that binds to RANK Ligand, a protein essential for the formation, function and survival of the osteoclast cells that break down bone. Denosumab prevents RANK Ligand from activating its receptor and initiating bone destruction.
One thousand ninety four men at 342 research sites worldwide participated in this trial that evaluated denosumab administered every four weeks via a 120 mg subcutaneous injection plus intravenous placebo, versus zoledronic acid administered every four weeks via a 4mg intravenous infusion plus subcutaneous placebo. The focus of this study was to determine the time to first on-study (either denosumab or zoledronic acid) skeletal related event for patients, which could include pathological fracture (broken bone in an area of weakened bone), need for radiation therapy or surgery to bone or spinal cord compression. The average time to first on-study skeletal event for men enrolled in this trial was 20.7 months with denosumab compared to 17.1 months with zoledronic acid. Overall, 36 percent of patients in the denosumab group experienced bone events compared with 41 percent in the zoledronic acid group.
“This clinical trial and subsequent FDA approval of denosumab represents the first antibody of its kind to be studied for the management of skeletal complications in prostate cancer and the first bone-targeted therapy for cancer patients to be approved in more than a decade,” said Dr. Karsh. “Denosumab is a novel treatment therapy that is easier to administer and results in better quality of life outcomes for patients. The TUCC Clinical Research Department’s participation in this trial illustrates our continued commitment to providing patients in the Rocky Mountain region with access to tomorrow’s urologic therapies today.”
The nationally recognized TUCC Clinical Research Department participates in all phases of clinical trials for a variety of urologic conditions. In 2008, the department was awarded acceptance into the Society of Urologic Oncology Clinical Trials Consortium. TUCC is one of only 22 large urology groups in the country with this designation.
To view the entire denosumab study published in The Lancet, please visit click here. To learn more about clinical research currently taking place at TUCC, please visit www.tucc.com or call 303.825.TUCC (8822).