MONTREAL—Denosumab significantly prolongs bone metastasis-free survival (BMFS) and delays time to bone metastasis in men with castration-resistant prostate cancer (CRPC), according to data presented at the Canadian Urological Association annual meeting.
In an international study of 1,432 men with CRPC and at high risk for bone metastasis, subjects treated with denosumab had a median time to BMFS that was 4.2 months longer than that of patients who received placebo. Bone metastases were 15% less likely to develop among denosumab recipients than placebo-treated patients. The time to first bone metastasis was 29.5 and 25.2 months, respectively. Overall survival was similar for the denosumab and placebo arms. In general, the two groups had similar rates of adverse events (AEs) and serious AEs.
The study was presented by Fred Saad, MD, of Centre Hospitalier de l’Université de Montréal.
To be enrolled in the study, men needed to have a PSA value of 8.0 ng/mL or higher three months or less before randomization and/or PSA doubling time of 10 months or less. They also had to have a total serum testosterone level below 50 ng/dL.