At a glance
ClinicalIndex Comparison Record- ✓Histologically documented prostate adenocarcinoma
- ✓At least one bone metastasis confirmed by radiographic imaging (bone scan, MRI, CT, or plain radiographs)
- ✓Currently receiving androgen deprivation therapy (ADT initiated ≤6 months prior to enrollment)
- ✓ECOG performance status 0-2
- ✕Small cell, neuroendocrine, or transitional cell carcinomas of the prostate
- ✕Prior bisphosphonate therapy
- ✕Prior denosumab therapy
- ✕Prior radiopharmaceutical therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
In Brief
A Phase 3 clinical trial evaluating zoledronic acid, placebo, and 4 other interventions for Metastatic Cancer and Prostate Cancer. Completed, enrolled 645 participants across 241 sites in 2 countries.
Detailed Summary
RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases. PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.
Study Details
Timeline
Interventions
Given IV
Given IV
Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive androgen deprivation therapy per SWOG-9346. All other patients will receive androgen deprivation therapy at a standard dose and schedule throughout the study.
Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive the GnRH agonist per SWOG-9346. All other patients will receive GnRH agonist at a standard dose and schedule throughout the study.
Patients will receive 500 mg by mouth daily of a calcium supplement or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.
Patients will receive a multivitamin tablet containing 400-500 IU vitamin D by mouth daily or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.