Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006214
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-09-11
Brief Title:
Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Short-Term Chemoprevention Trial in Men With Prostatic Intraepithelial Neoplasia Using Flutamide as an Androgen Deprivation Agent
Status:
COMPLETED
Status Verified Date:
2016-07
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 such as flutamide to try to prevent the development of cancer Flutamide may be effective in the prevention of prostate cancer
PURPOSE Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate
PURPOSE Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate
Detailed Description:
OBJECTIVES I Determine the ability of flutamide to reduce the incidence of prostate cancer in patients with high grade prostatic intraepithelial neoplasia II Determine the effect of this regimen on a series of endpoint biomarkers in these patients III Assess the quality of life of these patients
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to age under 65 versus 65 and over PSA 0-25 versus 26-40 versus 41-10 versus greater than 10 ngmL PIN on one biopsy versus on two biopsies and family history prostate cancer in brother father or uncle versus no prostate cancer in these relatives Patients are randomized to one of two treatment arms
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to age under 65 versus 65 and over PSA 0-25 versus 26-40 versus 41-10 versus greater than 10 ngmL PIN on one biopsy versus on two biopsies and family history prostate cancer in brother father or uncle versus no prostate cancer in these relatives Patients are randomized to one of two treatment arms
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 |
|---|---|---|---|
| CDR0000067929 | REGISTRY | None | None |
| MAYO-959257 | None | None | None |
| MAYO-IRB-921-97 | None | None | None |
| NCI-P00-0156 | Registry Identifier | PDQ Physician Data Query | None |