Abstract | PURPOSE: PATIENTS AND METHODS: Men with castration-sensitive prostate cancer and bone metastases whose androgen-deprivation therapy was initiated within 6 months of study entry were randomly assigned in a blinded 1:1 ratio to receive zoledronic acid (4 mg intravenously every 4 weeks) or a placebo. After their disease progressed to castration-resistant status, all patients received open-label treatment with zoledronic acid. The primary end point was time to first SRE, defined as radiation to bone, clinical fracture, spinal cord compression, surgery to bone, or death as a result of prostate cancer. Target accrual was 680 patients. Primary analysis was planned after 470 SREs. The study was discontinued prematurely (645 patients; 299 SREs) after the corporate supporter withdrew study drug supply. RESULTS: Early zoledronic acid was not associated with increased time to first SRE. The median time to first SRE was 31.9 months in the zoledronic acid group (95% CI, 24.2 to 40.3) and 29.8 months in the placebo group (95% CI, 25.3 to 37.2; hazard ratio, 0.97; 95% CI, 0 to 1.17; one-sided stratified log-rank P = .39). Overall survival was similar between the groups (hazard ratio, 0.88; 95% CI, 0.70 to 1.12; P = .29). Rates of adverse events were similar between the groups. CONCLUSION:
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Authors | Matthew R Smith, Susan Halabi, Charles J Ryan, Arif Hussain, Nicholas Vogelzang, Walter Stadler, Ralph J Hauke, J Paul Monk, Philip Saylor, Nirmala Bhoopalam, Fred Saad, Ben Sanford, W Kevin Kelly, Michael Morris, Eric J Small |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 32
Issue 11
Pg. 1143-50
(Apr 10 2014)
ISSN: 1527-7755 [Electronic] United States |
PMID | 24590644
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androgen Antagonists
- Bone Density Conservation Agents
- Diphosphonates
- Imidazoles
- Zoledronic Acid
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Topics |
- Adenocarcinoma
(drug therapy, secondary)
- Aged
- Androgen Antagonists
(therapeutic use)
- Bone Density Conservation Agents
(therapeutic use)
- Bone Neoplasms
(diagnosis, drug therapy, secondary)
- Diagnostic Imaging
- Diphosphonates
(therapeutic use)
- Disease Progression
- Humans
- Imidazoles
(therapeutic use)
- Male
- Orchiectomy
- Prostatic Neoplasms
(drug therapy, pathology)
- Treatment Outcome
- Zoledronic Acid
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