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Influence of Selenium on Biomarkers of Prostate Cancer Risk

This study is currently recruiting participants.
Verified July 2011 by Penn State University
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01112449
First received: April 23, 2010
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

Penn State Milton S. Hershey Medical Center researchers are trying to determine if selenium yeast and selenomethionine lower prostate-specific antigen levels and prevent other markers related to prostate cancer development in healthy individuals of different age groups. One in six men are at risk of getting prostate cancer in their lifetime. Participants will be asked to take over-the-counter selenium yeast supplements and selenomethionine or a placebo for twelve out of eighteen months.


Condition Intervention
Prostate Cancer
 Other: Placebo
Drug: SM
Drug: Third Group
Drug: Fourth Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Influence of Selenium on Biomarkers of Prostate Cancer Risk

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • PSA levels [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Testosterone metabolism [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Third Group
The third group will receive 200 µg/day of SY
 Drug: Third Group
The third group will receive 200 µg/day of SY
Other Names:
  • selenium-enriched yeast
  • SY
Experimental: Second Group
The second group will receive 200 µg/day of SM
 Drug: SM
200 µg/day of selenomethionine (SM)
Other Names:
  • selenomethionine
  • SM
Placebo Comparator: Treatment Group One
One group will receive placebo, no active medication.
 Other: Placebo
One group will receive placebo
Other Name: Placebo
Experimental: Fourth Goup
The fourth group will receive 285 µg/day of SY. The subject will take one pill daily for 12 months and report for outpatient visits at 3,6,7,12 and 18 months and have blood and urine samples collected.
 Drug: Fourth Group
The fourth group will receive 285 µg/day of SY
Other Names:
  • selenium-enriched yeast
  • SY

Detailed Description:

We will conduct a double-blind, randomized, placebo-controlled clinical study of selenium supplementation in the form of L-selenomethionine (SM)(200 µg/day) and selenium-enriched yeast (SY) (200 µg/day and 285 µg/day) for 12 months; the 285 µg/day SY is selected to deliver an equivalent selenium as in 200 µg/day SM to healthy men. Some time during the 12 months study period, all groups will take the placebo pill for at least 3 months. The subjects will compose of African Americans, Hispanics, and white Americans in different age groups defined as follows: Young adult (20-39 year old), Matured adult (40-59 year old), Old adult (60-79 year old). The Young adult group will serve as a reference group and will be used to validate our previous results. The variability of SM in SY that will be used here is less than 3% and it accounts for 70.5% of the SM content in SY.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No history or evidence of diabetes
  • Male between the ages of 20-79
  • PSA levels ≤ 4.0 ng/mL
  • Not taking >50 µg/day selenium as a dietary supplement including multi- vitamins
  • Non-smoker
  • No concurrently participating or have participated in any other clinical trial within at least 30 days of registration
  • Health male

Exclusion Criteria:

  • Evidence of prostate cancer
  • Evidence of liver or kidney disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112449

Contacts
Contact: Karam El-Bayoumy, PhD 717-531-1005 kee2@psu.edu
Contact: Wanda Neidig 717-531-1002 wneidig@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Milton Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Karem El-Bayoumy, PhD     717-531-1005        
Contact: Wanda Neidig     717-531-2001     wneidig@hmc.psu.edu    
Principal Investigator: Karem El-Bayoumy, PhD            
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Karam El-Bayoumy, PhD Penn State College of Medicine
  More Information

No publications provided

Responsible Party: Karam El-Bayoumy, PhD, Professor of Biochemistry & Molecular Biology, Penn State Hershey Cancer Institute
ClinicalTrials.gov Identifier: NCT01112449     History of Changes
Other Study ID Numbers: PSHCI 08-012
Study First Received: April 23, 2010
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
prostate cancer
PSA
testosterone

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Selenium
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on May 23, 2013