Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345813
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2006-06-28
Brief Title:
Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
Status:
COMPLETED
Status Verified Date:
2018-08
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 Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery
PURPOSE This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer
PURPOSE This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation proliferation differentiation apoptosis and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy
Secondary
Compare the toxicity and side effects of these regimens in these patients
Compare the dietary patterns of these patients
OUTLINE This is a prospective randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral soy supplementation daily for 4 weeks
Arm II Patients receive oral placebo supplementation daily for 4 weeks Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation
Blood and tissue samples are collected for biomarker analysis using immunohistochemistry
Primary
Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation proliferation differentiation apoptosis and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy
Secondary
Compare the toxicity and side effects of these regimens in these patients
Compare the dietary patterns of these patients
OUTLINE This is a prospective randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral soy supplementation daily for 4 weeks
Arm II Patients receive oral placebo supplementation daily for 4 weeks Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation
Blood and tissue samples are collected for biomarker analysis using immunohistochemistry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CCCWFU-98203 | None | None | None |
| CCCWFU-BG03-332 | None | None | None |