Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
SePros
4 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2007
CompletedFirst Posted
Study publicly available on registry
March 13, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 14, 2011
March 1, 2011
3.6 years
March 12, 2007
March 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
selenium levels in prostate tissue
after 5 weeks of intervention with selenium or placebo
changes in gene expression profiles in prostate tissue
after 5 weeks of intervention with selenium or placebo
Secondary Outcomes (2)
changes in blood flow, vessel permeability and exocrine functionality
after 5 weeks of intervention with selenium or placebo
changes in gene expression profiles in blood cells
after 5 weeks of intervention with selenium or placebo
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo
Selenium (selenized yeast)
EXPERIMENTALSelenium (selenized yeast) tablets, 300 ug/day
Interventions
Selenized yeast, 300 ug/day
Eligibility Criteria
You may qualify if:
- male
- biopsy proven prostate cancer
- scheduled for radical prostatectomy
You may not qualify if:
- liver diseases (e.g. hepatitis)
- kidney diseases
- inflammatory bowel diseases
- use of dietary supplements containing selenium
- adjuvant therapy for prostate cancer (e.g. hormonal therapy, HIFU)
- previously or concurrent diagnosed with cancer, other than prostate cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- World Cancer Research Fund Internationalcollaborator
Study Sites (2)
University Medical Centre St Radboud
Nijmegen, Gelderland, 6500 HB, Netherlands
Wageningen University
Wageningen, Gelderland, 6700 EV, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
J.A. Witjes, Md PhD Prof
University Medical Center St Radboud
- STUDY CHAIR
L.A.L.M. Kiemeney, PhD Prof
University Medical Center St Radboud
- STUDY CHAIR
P. van 't Veer, PhD Prof
Wageningen University
- STUDY CHAIR
L.A. Afman, PhD
Wageningen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 12, 2007
First Posted
March 13, 2007
Study Start
June 1, 2007
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 14, 2011
Record last verified: 2011-03