Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005073
Status:
TERMINATED
Last Update Posted:
2013-05-01
First Post:
2000-04-06
Brief Title:
Zoledronate Plus Standard Therapy Compared With Placebo Plus Standard Therapy to Prevent Bone Metastases in Patients With Recurrent Prostate Cancer That Has No Symptoms
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Phase III Trial Evaluating Zoledronate Plus Standard Therapy Versus Placebo Plus Standard Therapy in Patients With Recurrent Carcinoma of the Prostate Who Are Asymptomatic With Castrate Levels of Testosterone and Have Rising PSA Levels Without Radiologically-Evident Metastatic Disease
Status:
TERMINATED
Status Verified Date:
2013-04
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 be able to prevent bone metastases caused by prostate cancer It is not yet known if zoledronate is effective in preventing the spread of prostate cancer to the bones
PURPOSE Randomized phase III trial to determine the effectiveness of zoledronate plus standard therapy in preventing bone metastases in patients who have recurrent prostate cancer that is not causing symptoms
PURPOSE Randomized phase III trial to determine the effectiveness of zoledronate plus standard therapy in preventing bone metastases in patients who have recurrent prostate cancer that is not causing symptoms
Detailed Description:
OBJECTIVES I Compare the bone metastases free and overall survival in patients with asymptomatic recurrent prostate cancer treated with zoledronate vs placebo at different time points II Compare the time to first skeletal related events pathological fractures surgery to prevent or treat pathological fractures spinal cord compression and radiotherapy to bone and skeletal morbidity rate in patients treated with these 2 regimens III Assess quality of life and pain in these patients treated with these 2 regimens
OUTLINE This is a randomized double blind placebo controlled open label multicenter study Patients are stratified by prior local treatment noncurative vs curative and time interval between surgical castration or initiation of LHRH agonists and trial entry less than 1 year vs 1-2 years vs greater than 2 years Patients are randomized to 1 of 2 treatment arms Arm I Patients receive zoledronate IV over 15 minutes on day 1 Arm II Patients receive placebo IV over 15 minutes on day 1 Both arms Treatment repeats every 4 weeks in the absence of documented bone metastasis disease progression or unacceptable toxicity All patients with documented bone metastases receive zoledronate as in arm I through year 4 All patients receive oral calcium and oral vitamin D daily Patients who received LHRH agonists instead of surgical castration prior to study continue LHRH agonist therapy during study Quality of life and pain are assessed before each treatment Patients are followed every 6 months
PROJECTED ACCRUAL A total of 500 patients 250 per arm will be accrued for this study
OUTLINE This is a randomized double blind placebo controlled open label multicenter study Patients are stratified by prior local treatment noncurative vs curative and time interval between surgical castration or initiation of LHRH agonists and trial entry less than 1 year vs 1-2 years vs greater than 2 years Patients are randomized to 1 of 2 treatment arms Arm I Patients receive zoledronate IV over 15 minutes on day 1 Arm II Patients receive placebo IV over 15 minutes on day 1 Both arms Treatment repeats every 4 weeks in the absence of documented bone metastasis disease progression or unacceptable toxicity All patients with documented bone metastases receive zoledronate as in arm I through year 4 All patients receive oral calcium and oral vitamin D daily Patients who received LHRH agonists instead of surgical castration prior to study continue LHRH agonist therapy during study Quality of life and pain are assessed before each treatment Patients are followed every 6 months
PROJECTED ACCRUAL A total of 500 patients 250 per arm will be accrued for this 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 |
|---|---|---|---|
| NCI-G00-1722 | Registry Identifier | PDQ Physician Data Query | None |
| UCLA-9908030 | None | None | None |
| CDR0000067678 | REGISTRY | None | None |