Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079001
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2004-03-08
Brief Title:
Zoledronate in Preventing Skeletal Bone-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
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 upper limit of normal ULN vs 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
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 upper limit of normal ULN vs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CAN-NCIC-PRC2 | None | None | None |
| CDR0000353209 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |