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Denosumab Treatment for Prolonging Bone Metastasis-Free Survival in Men With Castrate-Resistant Prostate Cancer
Paul Sieber1, Matthew R Smith2, Fred Saad3, Robert Coleman4, Neal Shore5, Karim Fizazi6, Bertrand Tombal7, Kurt Miller8, Lawrence Karsh9, Ronaldo Damiao10
1Urological Associates of Lancaster, Lancaster, PA;2Massachusetts General Hospital, Boston, MA;3University of Montreal Hospital Center, CRCHUM, Montreal, QC, Canada4Weston Park Hospital, Sheffield, United Kingdom5Carolina Urologic Research Center, Myrtle Beach, SC;6Institut Gustave Roussy, University of Paris, Villejuif, France7Université Catholique de Louvain Cliniques Universitaires Saint Luc, Brussels, Belgium8Charité Berlin, Berlin, Germany9The Urology Center of Colorado, Denver, CO;10Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil
Introduction: Men with castrate-resistant prostate cancer (CRPC) are at increased risk for developing bone metastasis, which can result in pain and bone-related complications called skeletal-related events. This study assessed the ability of denosumab to prolong bone metastasis-free survival in men with CRPC at increased risk of developing bone metastasis.
Methods: Adult men with non-metastatic CRPC at high risk for developing bone metastasis (PSA value ≥8.0 ng/mL and/or PSA doubling time ≤10.0 months) and total serum testosterone of <50 ng/dL were randomized 1:1 in a blinded manner to receive subcutaneous injections of denosumab 120 mg or placebo monthly. Calcium and vitamin D supplements were advised. The primary endpoint of bone metastasis-free survival was determined by time to first bone metastasis or death from any cause. This trial was event driven. The first patient enrolled in February 2006.
Results: A total of 1432 subjects enrolled. Denosumab significantly improved bone metastasis-free survival compared with placebo (hazard ratio [HR] 0.85; 95% CI: 0.73, 0.98; P=0.03; median increase of 4.2 months), and significantly improved time to first occurrence of bone metastasis. Overall survival was similar between treatment groups. Overall rates of adverse events (AEs) and serious AEs were similar between groups, with the exception of ONJ and hypocalcemia.
Conclusions: In patients with CRPC, denosumab significantly prolonged bone metastasis-free survival by delaying time to bone metastasis.
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