Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT00978718
Status:
COMPLETED
Last Update Posted:
2012-08-15
First Post:
2009-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selenium in Preventing Prostate Cancer
Sponsor:
University of Arizona
Organization:
Study Overview
Official Title:
Phase III Trial of Selenium for Prostate Cancer Prevention
Status:
COMPLETED
Status Verified Date:
2012-08
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: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer.
PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.
PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.
Detailed Description:
OBJECTIVES:
* To determine whether selenium (Se) supplementation decreases the incidence of prostate cancer.
* To determine whether Se supplementation inhibits the biochemical progression of prostate cancer.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
* Arm II: Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
* Arm III: Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Blood samples are collected at baseline, at randomization, and then semi-annually for laboratory and other testing. Tissue samples may also be collected for biomarker analysis. Patients complete an initial questionnaire and urological-symptoms questionnaire at baseline, a follow-up questionnaire after randomization (to capture new illness, medications, and toxicity symptoms during the 30-day run-in period; a urological-symptoms questionnaire; a food-frequency questionnaire; and a mood questionnaire). Patients then undergo questionnaires semi-annually, including vital status, tablet compliance, nutrition, mood, new illnesses or medications, and any incidence of cancer or family history of cancer).
* To determine whether selenium (Se) supplementation decreases the incidence of prostate cancer.
* To determine whether Se supplementation inhibits the biochemical progression of prostate cancer.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
* Arm II: Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
* Arm III: Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Blood samples are collected at baseline, at randomization, and then semi-annually for laboratory and other testing. Tissue samples may also be collected for biomarker analysis. Patients complete an initial questionnaire and urological-symptoms questionnaire at baseline, a follow-up questionnaire after randomization (to capture new illness, medications, and toxicity symptoms during the 30-day run-in period; a urological-symptoms questionnaire; a food-frequency questionnaire; and a mood questionnaire). Patients then undergo questionnaires semi-annually, including vital status, tablet compliance, nutrition, mood, new illnesses or medications, and any incidence of cancer or family history of cancer).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA077789 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA023074 | NIH | None | https://reporter.nih.gov/quic… | View |
| UARIZ-99-0045-01, | OTHER | CDR0000654651 | View |