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Prostate

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

Unique Dataset IDnci-data-55ClinicalTrial.gov IDNCT00079001
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients645RandomizationYesPubMed (PMID)24590644.0
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeDrug, Targeted TherapyDataset TypeOther

NCI Description

NCT00079001-D3-Dataset.csv (ae) is one of 3 datasets associated with PubMed ID 24590644. This dataset contains information that will allow you to reproduce the toxicity reported.

Clinical Trial Title

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

Trial Summary and Conditions

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.

Data Summary

See data dictionary for more details.

Study Objectives

Zoledronic acid decreases the risk of skeletal related events in men with prostate cancer metastatic to bone and disease progression after primary hormonal therapy. This study is designed to evaluate whether earlier treatment with zoledronic acid will further decrease the risk of skeletal related events. This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs 2), prior skeletal-related event (no vs yes), and serum alkaline phosphatase (less than upper limit of normal [ULN] vs greater than or equal to ULN). The primary objective of the study is to determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. The secondary objective of the study is to compare the effect of treatment with zoledronic acid to placebo on overall survival (OS), progression-free survival (PFS) and toxicity in men receiving androgen deprivation therapy for metastatic prostate cancer. Patients are randomized to 1 of 2 treatment arms. Treatment continues in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy with a GnRH agonist. Patients also receive oral calcium and (vitamin D) supplements daily. Patients progressing to androgen-independent prostate cancer proceed to the open-label therapy with zoledronic acid IV. Treatment continues for 3 weeks in the absence of disease progression or the first skeletal-related event. Patients are followed periodically for approximately 10 years after entry on the study.

Outcome Measures

Primary: Time to First Skeletal Related Event [ Time Frame: Up to 10 years ] Secondary: Overall Survival [ Time Frame: Up to 10 years ] Progression-free Survival [ Time Frame: Up to 10 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

Available Downloads:

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