Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042731
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2002-08-05
Brief Title:
Isoflavones Lycopene in Localized Prostate CaPrior to Radical Prostatectomy
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer Administration Prior To Radical Prostatectomy
Status:
COMPLETED
Status Verified Date:
2012-09
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 Eating a diet rich in isoflavones compounds found in soy foods or lycopene a substance found in tomatoes may keep prostate cancer from growing Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer
PURPOSE Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer
PURPOSE Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer
Detailed Description:
OBJECTIVES
Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers eg indices of cell proliferation and apoptosis in patients with localized prostate cancer
Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients
Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression eg prostate-specific antigen levels in these patients
Compare the effects of these nutritional supplements on changes in serum steroid hormones estradiol and free testosterone in these patients
Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage stage I vs stage II and presence of high-grade prostatic intraepithelial neoplasia Patients are randomized to 1 of 7 treatment groups
PROJECTED ACCRUAL A total of 87 patients will be accrued for this study within 1 year
Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers eg indices of cell proliferation and apoptosis in patients with localized prostate cancer
Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients
Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression eg prostate-specific antigen levels in these patients
Compare the effects of these nutritional supplements on changes in serum steroid hormones estradiol and free testosterone in these patients
Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group
OUTLINE This is a randomized multicenter study Patients are stratified according to disease stage stage I vs stage II and presence of high-grade prostatic intraepithelial neoplasia Patients are randomized to 1 of 7 treatment groups
PROJECTED ACCRUAL A total of 87 patients will be accrued for this study within 1 year
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-3811 | OTHER | None | None |
| NCI-P02-0216 | OTHER | None | None |
| 0105 | OTHER | CCOP | None |