Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030901
Status:
COMPLETED
Last Update Posted:
2013-02-06
First Post:
2002-02-14
Brief Title:
S9917 Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia
Status:
COMPLETED
Status Verified Date:
2013-01
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 the development of cancer The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate
PURPOSE Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate
PURPOSE Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate
Detailed Description:
OBJECTIVES
Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia
Compare the toxicity of these regimens in these patients
Compare the effects of these regimens on the rate of increase in prostate-specific antigen PSA in these patients
Compare the effects of these regimens on prostatic cellular proliferation and apoptosis degradation of basal cell integrity of prostatic ducts and changes in nuclear chromatin patterns in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 40-60 vs 61 and over race African American vs other baseline PSA less than 4 ngmL vs 4-10 ngmL concurrent vitamin E supplementation yes vs no and cores obtained from initial biopsy 10 or more vs less than 10 Patients are randomized to 1 of 2 arms
Arm I Patients receive oral selenium once daily
Arm II Patients receive oral placebo once daily Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually for 8 years
PROJECTED ACCRUAL A total of 465 patients will be randomized for this study
Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia
Compare the toxicity of these regimens in these patients
Compare the effects of these regimens on the rate of increase in prostate-specific antigen PSA in these patients
Compare the effects of these regimens on prostatic cellular proliferation and apoptosis degradation of basal cell integrity of prostatic ducts and changes in nuclear chromatin patterns in these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to age 40-60 vs 61 and over race African American vs other baseline PSA less than 4 ngmL vs 4-10 ngmL concurrent vitamin E supplementation yes vs no and cores obtained from initial biopsy 10 or more vs less than 10 Patients are randomized to 1 of 2 arms
Arm I Patients receive oral selenium once daily
Arm II Patients receive oral placebo once daily Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity
Patients are followed every 6 months for 2 years and then annually for 8 years
PROJECTED ACCRUAL A total of 465 patients will be randomized for this study
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 |
|---|---|---|---|
| U10CA037429 | NIH | None | None |
| S9917 | OTHER | None | None |
| CALGB-70004 | OTHER | None | None |
| NCI-P02-0203 | OTHER | NCI grant | httpsreporternihgovquickSearchU10CA037429 |