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Prostate

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

Unique Dataset IDProstat_Allianc_2004_215
DownloadableYes
SponsorAlliance for Clinical Trials in OncologyData ProviderThe Alliance for Clinical Trials in OncologyTotal Study Enrolled Patients645Comparator (Control) Arm Enrolled Patients322Experimental (Active) Arm Enrolled Patients323RandomizationYesClinicalTrial.gov IDNCT00079001ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/study/NCT00079001?term=calgb+90202&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataBoth comparator and experimental arm dataIntervention TypePlacebo, DrugDataset TypeADS

Clinical Trial Title

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

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

Data files include data on safety, efficacy, and demographics. See the data dictionary for complete details.

Study Objectives

Primary: 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. Secondary: 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.

Outcome Measures

Primary: Time to First Skeletal Related Event Secondary: Overall Survival Secondary: Progression-free Survival

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 90202Prot_05Feb2008.pdf

CRF: 90202-all-forms.pdf

DATA DICTIONARY: c90202_datadictionary.pdf

DATA (BOTH COMPARATOR AND ACTIVE ARMS): ae.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): analysis.csv

DATA (BOTH COMPARATOR AND ACTIVE ARMS): baseline.csv