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Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression (SePros)

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ClinicalTrials.gov Identifier: NCT00446901
Recruitment Status : Completed
First Posted : March 13, 2007
Last Update Posted : March 14, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Prostate Cancer Dietary Supplement: Selenium

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
Study Start Date : June 2007
Primary Completion Date : January 2011
Study Completion Date : January 2011

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Selenium
Selenized yeast, 300 ug/day
Other Name: SelenoPrecise, PharmaNord
Experimental: Selenium (selenized yeast)
Selenium (selenized yeast) tablets, 300 ug/day
Dietary Supplement: Selenium
Selenized yeast, 300 ug/day
Other Name: SelenoPrecise, PharmaNord


Outcome Measures

Primary Outcome Measures :
  1. selenium levels in prostate tissue [ Time Frame: after 5 weeks of intervention with selenium or placebo ]
  2. changes in gene expression profiles in prostate tissue [ Time Frame: after 5 weeks of intervention with selenium or placebo ]

Secondary Outcome Measures :
  1. changes in blood flow, vessel permeability and exocrine functionality [ Time Frame: after 5 weeks of intervention with selenium or placebo ]
  2. changes in gene expression profiles in blood cells [ Time Frame: after 5 weeks of intervention with selenium or placebo ]

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male
  • biopsy proven prostate cancer
  • scheduled for radical prostatectomy

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446901


Locations
Netherlands
University Medical Centre St Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
Wageningen University
World Cancer Research Fund International
Investigators
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
More Information

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT00446901     History of Changes
Other Study ID Numbers: WCRF 2004/21
CMO nr. 2007/003
SePros 2006/02
NL14694.091.07
First Posted: March 13, 2007    Key Record Dates
Last Update Posted: March 14, 2011
Last Verified: March 2011

Keywords provided by Wageningen University:
Prostate Cancer
Selenium
Chemoprevention
Gene expression

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