Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006101
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2000-08-03
Brief Title:
Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer
Sponsor:
Thomas E Ahlering
Organization:
University of California Irvine
Study Overview
Official Title:
Randomized Placebo-Controlled Double-Blind Phase IIb Chemoprevention Trial of Difluoromethylornithine in Brothers and First Cousin Males of Familial Prostate Cancer Probands
Status:
COMPLETED
Status Verified Date:
2018-04
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer The use of eflornithine DMFO may be an effective way to prevent the development of prostate cancer
PURPOSE Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease
PURPOSE Randomized phase II trial to determine the effectiveness of eflornithine in preventing prostate cancer in patients who are at high risk of developing the disease
Detailed Description:
OBJECTIVES
Compare the levels of polyamines putrescine spermidine and spermine and progression-related genes in the prostate tissue of patients at high genetic risk for prostate cancer treated with eflornithine DFMO vs placebo
Determine the side effects of DFMO and compare them with the biological effect on the prostate gland in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to age 35 to 60 vs 61 to 70 and presence of localized cancer yes vs no
All patients receive oral placebo daily for 4 weeks Patients who are compliant and take the placebo 5-7 days each week are randomized to one of two arms
Arm I Patients receive oral placebo daily
Arm II Patients receive high-dose oral eflornithine DFMO daily Treatment continues for 1 year in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 100 patients 50 per arm will be accrued for this study within 3 years
Compare the levels of polyamines putrescine spermidine and spermine and progression-related genes in the prostate tissue of patients at high genetic risk for prostate cancer treated with eflornithine DFMO vs placebo
Determine the side effects of DFMO and compare them with the biological effect on the prostate gland in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to age 35 to 60 vs 61 to 70 and presence of localized cancer yes vs no
All patients receive oral placebo daily for 4 weeks Patients who are compliant and take the placebo 5-7 days each week are randomized to one of two arms
Arm I Patients receive oral placebo daily
Arm II Patients receive high-dose oral eflornithine DFMO daily Treatment continues for 1 year in the absence of unacceptable toxicity
PROJECTED ACCRUAL A total of 100 patients 50 per arm will be accrued for this study within 3 years
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-2009-00890 | OTHER | NCI Clinical Trials Reporting Program | None |
| U01CA8188601 | OTHER | None | None |
| NCI-P00-0164 | OTHER | None | None |