Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00446901
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
2007-03-12
Brief Title:
Selenium and Prostate Cancer Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
Selenium and Prostate Cancer Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
Status:
COMPLETED
Status Verified Date:
2011-03
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:
SePros
Brief Summary:
The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue
Detailed Description:
Rationale Prostate cancer is a frequently observed malignancy in men especially in elderly men Besides diagnosis and treatment also prevention of prostate cancer is an important point of interest to reduce the incidence and mortality of prostate cancer Selenium is considered to be a promising chemopreventive agent for prostate cancer Exact mechanisms of chemoprevention by selenium are not fully understood However it is expected that selenium among other effects directly affects gene expression in the prostate
Objective The aim of this study is to get insight into bioavailability of selenium in prostate tissue and changes of gene expression profiles that might be responsible for selenium-induced chemoprevention To meet this objective the relationship between dietary selenium intake and changes in gene expression profiles tissue selenium levels and blood flow in prostate tissue will be examined
Study design The present study is designed as a double-blind randomized and placebo-controlled intervention trial Blood samples toenails questionnaires MR images and surgical specimens will be collected to examine effects of selenium supplementation
Study population The study population will consist of 60 men diagnosed with prostate cancer and scheduled for radical prostatectomy Written informed consent will be obtained from each participant
Intervention Participants will receive 300 ug selenium day or a placebo during 5 weeks prior to radical prostatectomy Selenium will be supplemented in the form of selenized yeast tablets SelenoPrecise Pharma Nord
Main study parameters Levels of selenium in prostate tissue and changes in prostate gene expression profiles of participants supplemented with selenium or placebo compared before and after the short intervention period will be considered as the main parameters of the present study Besides gene expression profiles in prostate tissue also gene expression profiles of peripheral mononuclear cells PBMC levels of selenium in blood and toenails and blood flow and permeability of blood vessels of prostate tissue will be analyzed
Objective The aim of this study is to get insight into bioavailability of selenium in prostate tissue and changes of gene expression profiles that might be responsible for selenium-induced chemoprevention To meet this objective the relationship between dietary selenium intake and changes in gene expression profiles tissue selenium levels and blood flow in prostate tissue will be examined
Study design The present study is designed as a double-blind randomized and placebo-controlled intervention trial Blood samples toenails questionnaires MR images and surgical specimens will be collected to examine effects of selenium supplementation
Study population The study population will consist of 60 men diagnosed with prostate cancer and scheduled for radical prostatectomy Written informed consent will be obtained from each participant
Intervention Participants will receive 300 ug selenium day or a placebo during 5 weeks prior to radical prostatectomy Selenium will be supplemented in the form of selenized yeast tablets SelenoPrecise Pharma Nord
Main study parameters Levels of selenium in prostate tissue and changes in prostate gene expression profiles of participants supplemented with selenium or placebo compared before and after the short intervention period will be considered as the main parameters of the present study Besides gene expression profiles in prostate tissue also gene expression profiles of peripheral mononuclear cells PBMC levels of selenium in blood and toenails and blood flow and permeability of blood vessels of prostate tissue will be analyzed
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 |
|---|---|---|---|
| NL1469409107 | None | None | None |
| CMO nr 2007003 | None | None | None |
| SePros 200602 | None | None | None |