Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031746
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2002-03-08
Brief Title:
Soy Protein Supplement in Preventing Prostate Cancer in Patients With Elevated Prostate-Specific Antigen Levels
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Effects of Dietary Soy on Biomarkers of Prostate Cancer A Prospective Phase II Study
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 Soy protein supplement may prevent or delay the development of prostate cancer in patients who have elevated prostate-specific antigen PSA levels
PURPOSE Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels
PURPOSE Randomized phase II trial to determine the effectiveness of soy protein supplement in preventing prostate cancer in patients who have elevated PSA levels
Detailed Description:
OBJECTIVES
Compare the reduction in the rate of prostatic cellular proliferation in patients with an elevated PSA 5 to 10 ngmL and a negative biopsy for prostate cancer when treated with daily soy protein supplements vs placebo
Compare the effect of these regimens on additional biomarkers of prostate cancer PSA high-grade prostate intraepithelial neoplasia induction of apoptosis sex steroid receptor expression and loss of glutathione S-transferase-pi in these patients
Compare the effect of these regimens on quality of life including urinary and sexual function in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to race Caucasian vs African American After 2 weeks of daily oral placebo patients are randomized to 1 of 2 arms
Arm I Patients receive oral soy protein supplement daily for 12 months
Arm II Patients receive oral placebo daily for 12 months Quality of life is assessed at baseline and at 6 and 12 months
PROJECTED ACCRUAL A total of 160 patients 80 per arm will be accrued for this study within 12 months
Compare the reduction in the rate of prostatic cellular proliferation in patients with an elevated PSA 5 to 10 ngmL and a negative biopsy for prostate cancer when treated with daily soy protein supplements vs placebo
Compare the effect of these regimens on additional biomarkers of prostate cancer PSA high-grade prostate intraepithelial neoplasia induction of apoptosis sex steroid receptor expression and loss of glutathione S-transferase-pi in these patients
Compare the effect of these regimens on quality of life including urinary and sexual function in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to race Caucasian vs African American After 2 weeks of daily oral placebo patients are randomized to 1 of 2 arms
Arm I Patients receive oral soy protein supplement daily for 12 months
Arm II Patients receive oral placebo daily for 12 months Quality of life is assessed at baseline and at 6 and 12 months
PROJECTED ACCRUAL A total of 160 patients 80 per arm will be accrued for this study within 12 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 |
|---|---|---|---|
| CDR0000069221 | REGISTRY | NCI Physicians Data Query | httpsreporternihgovquickSearchU10CA076001 |
| U10CA076001 | NIH | None | None |
| CALGB-79806 | None | None | None |
| NCI-P02-0207 | None | None | None |