Skip to main content
. Author manuscript; available in PMC: 2011 May 10.
Published in final edited form as: Clin Genitourin Cancer. 2010 Dec 1;8(1):29–36. doi: 10.3816/CGC.2010.n.005

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
a

Targeted accrual.

Abbreviation: PSA = prostate-specific antigen