Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064194
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2003-07-08
Brief Title:
Vitamin E Selenium and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Study Of Combination Vitamin E Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial Neoplasia
Status:
COMPLETED
Status Verified Date:
2020-04
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 substances to try to prevent the development or recurrence of cancer Vitamin E selenium and soy protein may be effective in preventing the development of prostate cancer
PURPOSE Randomized phase III trial to study the effectiveness of combining vitamin E selenium and soy protein in preventing prostate cancer in patients who have high-grade prostate neoplasia
PURPOSE Randomized phase III trial to study the effectiveness of combining vitamin E selenium and soy protein in preventing prostate cancer in patients who have high-grade prostate neoplasia
Detailed Description:
OBJECTIVES
Determine whether nutritional supplementation with soy protein isolate vitamin E and selenium can delay the time to development of invasive prostate cancer disease-free survival in patients with high-grade prostatic intraepithelial neoplasia
Determine the effect of this supplementation on intermediate endpoints that may reflect a lessened risk of invasive prostate cancer eg serum PSA levels hormone levels lycopene malondialdehyde vitamin E and reduced thiol groups in these patients
Determine the safety of this supplementation in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral vitamin E oral selenium and oral soy protein isolate twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 3 years in the absence of invasive prostate cancer demonstrated on biopsy or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 306 patients 153 per treatment arm will be accrued for this study within 6 years
Determine whether nutritional supplementation with soy protein isolate vitamin E and selenium can delay the time to development of invasive prostate cancer disease-free survival in patients with high-grade prostatic intraepithelial neoplasia
Determine the effect of this supplementation on intermediate endpoints that may reflect a lessened risk of invasive prostate cancer eg serum PSA levels hormone levels lycopene malondialdehyde vitamin E and reduced thiol groups in these patients
Determine the safety of this supplementation in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral vitamin E oral selenium and oral soy protein isolate twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 3 years in the absence of invasive prostate cancer demonstrated on biopsy or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 306 patients 153 per treatment arm will be accrued for this study within 6 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| CDR0000310096 | OTHER | PDQ | None |
| CAN-NCIC-PRP1 | OTHER | None | None |