Table 2. Randomized Controlled Trials of Osteoclast-Targeted Therapies in Prevention of Bone Metastasis in Nonmetastatic Prostate Cancer.
Study | Number of Patients | Study Population | Arms | Outcome |
---|---|---|---|---|
MRC PR0451 | 508 | Castration-sensitive, localized, clinical stage T2-T4 | 2080 mg daily oral clodronate versus placebo, for 5 years | No difference in development of bone metastasis or overall survival |
ZEUS53 | 1433 | Castration-sensitive, high-risk disease (PSA ≥ 20, lymph node-positive disease, or Gleason sum 8-10) | Standard prostate cancer therapy ± zoledronic acid 4 mg intravenously every 3 months for 48 months (open label) | Ongoing Primary objective: evaluate superiority of zoledronic acid over control in incidence of bone metastasis |
Denosumab Protocol 20050147 | 1400a | Castration-resistant, high risk by PSA criteria | Denosumab 120 mg versus placebo, every 4 weeks | Ongoing Primary endpoint: bone metastasis-free survival Final results expected, 2010 |
Targeted accrual.
Abbreviation: PSA = prostate-specific antigen