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Treatment Pending FDA Approval Shows New Promise for Patients

Denosumab may prolong metastasis-free survival in men with high-risk prostate cancer

Data on the use of denosumab (Xgeva) to improve bone metastases-free survival in men with high-risk prostate cancer was presented at the American Urological Association conference on Tuesday, May 17, 2011. If approved by the Food and Drug Administration (FDA), the use of denosumab injections will be the first successful treatment for bone metastasis prevention in prostate cancer.

Results from a new Phase III clinical trial were presented by lead researcher, professor Matthew Smith, MD, PhD, director of the Genitourinary Malignancies Program at Massachusetts General Hospital Cancer Center. Patient data was collected from more than 1,400 men in 30 countries who were at high-risk for developing bone metastases (due to rising PSA levels despite hormone therapy). Compared to the controlled placebo, monthly denosumab treatment significantly increased bone metastasis-free survival. Denosumab treatment also increased the time it takes to first bone metastasis and the time it takes to develop asymptomatic bone metastases. These findings are “first in field” results.

No other systemic therapy has been shown effective in delaying the development of bone metastasis in men with aggressive, castrate-resistant prostate cancer. Prevention of bone metastasis represents an important unmet medical need in patients with advanced disease.

Dr. Smith has been a Prostate Cancer Foundation (PCF) funding recipient since 1997 for his work in improving prostate cancer survivorship. PCF has invested more than $1.8 million in Dr. Smith and his team’s critical research on denosumab. The more than $1.8 million in funding support for Smith and denosumab from the Prostate Cancer Foundation came from peer reviewed, non-corporate academic grants starting in 1997.

This is the first time researchers have been able to control the tumor micro-environment to prevent metastases. Denosumab prevents cancerous cells from recruiting normal cells to assist in adhering to bone and forming metastatic tumors. The treatment does this through the inhibition of RANKL, a protein that activates signals that lead to the breakdown of bones. 

Denosumab is currently approved by the FDA for several other indications under generic names. Prolia was approved by the FDA on June 1, 2010 for the treatment of postmenopausal women with osteoporosis who are considered to be at high-risk for fractures. In November 2010, the FDA approved Xgeva to help prevent skeletal-related events (SREs) in hormone treated prostate cancer patients whose cancer had metastasized to bone.

Lead Investigator:
Matthew Smith, MD, PhD
Director of the Genitourinary Malignancies Program
Massachusetts General Hospital Cancer Center

Dr. Smith leads a clinical research program in prostate cancer focused on cancer survivorship, treatment and prevention of bone metastases, and novel therapeutics. With a multidisciplinary research team, he identified previously unrecognized adverse effects of androgen deprivation therapy including osteoporosis, sarcopenia, obesity, lipid alterations, insulin resistance, and greater risks for fractures, diabetes, and cardiovascular disease. These novel observations have provided fundamental insights in the management of prostate cancer and informed the design of global clinical trials to prevent treatment-related morbidity in prostate cancer survivors.

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