Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078923
Status:
COMPLETED
Last Update Posted:
2014-03-05
First Post:
2004-03-08
Brief Title:
Soy Isoflavones in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage I or Stage II Adenocarcinoma of the Prostate
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Clinical Trial of Soy Isoflavones Prior to Radical Prostatectomy
Status:
COMPLETED
Status Verified Date:
2014-03
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 or delay the development of early cancer Soy isoflavones may be effective in delaying the development of early prostate cancer
PURPOSE This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer adenocarcinoma
PURPOSE This randomized phase II trial is studying different regimens of soy isoflavones to compare how well they work in treating patients who are undergoing radical prostatectomy for stage I or stage II prostate cancer adenocarcinoma
Detailed Description:
OBJECTIVES
Compare bloodprostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy
Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens
Determine the potential response in terms of tumor and prostatic intraepithelial neoplasia grade and volume extraprostatic extension and serum prostate-specific antigen level in patients treated with soy isoflavones and in those treated with placebo
Determine the safety of soy isoflavone supplementation in these patients
OUTLINE This is a randomized double-blind placebo-controlled parallel-group study Patients are stratified according to tumor stage T1c vs T2 Patients are randomized to 1 of 4 treatment arms
Arm I control group Patients receive oral placebo once daily
Arm II Patients receive oral soy isoflavones and oral placebo once daily
Arm III Patients receive a higher dose of oral soy isoflavones and oral placebo once daily
Arm IV Patients receive a higher dose higher than arm III of oral soy isoflavones once daily
In all arms treatment continues for 2-6 weeks depending on the time from study entry to planned surgery in the absence of unacceptable toxicity All patients then undergo radical prostatectomy
Patients are followed at 1 week
PROJECTED ACCRUAL A total of 100 patients 25 per treatment arm will be accrued for this study within 125 months
Compare bloodprostate biomarkers of oxidative stress and prostate cancer risk in patients with stage I or II adenocarcinoma of the prostate treated with 3 different dose levels of soy isoflavones before radical prostatectomy
Compare prostatic tissue biomarkers of proliferation and apoptosis in patients treated with these regimens
Determine the potential response in terms of tumor and prostatic intraepithelial neoplasia grade and volume extraprostatic extension and serum prostate-specific antigen level in patients treated with soy isoflavones and in those treated with placebo
Determine the safety of soy isoflavone supplementation in these patients
OUTLINE This is a randomized double-blind placebo-controlled parallel-group study Patients are stratified according to tumor stage T1c vs T2 Patients are randomized to 1 of 4 treatment arms
Arm I control group Patients receive oral placebo once daily
Arm II Patients receive oral soy isoflavones and oral placebo once daily
Arm III Patients receive a higher dose of oral soy isoflavones and oral placebo once daily
Arm IV Patients receive a higher dose higher than arm III of oral soy isoflavones once daily
In all arms treatment continues for 2-6 weeks depending on the time from study entry to planned surgery in the absence of unacceptable toxicity All patients then undergo radical prostatectomy
Patients are followed at 1 week
PROJECTED ACCRUAL A total of 100 patients 25 per treatment arm will be accrued for this study within 125 months
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 |
|---|---|---|---|
| WSU-C-2418 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |