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

March 11, 2011 updated by: Wageningen University
The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • University Medical Centre St Radboud
      • Wageningen, Gelderland, Netherlands, 6700 EV
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Selenium
Selenized yeast, 300 ug/day
Other Names:
  • SelenoPrecise, PharmaNord
Experimental: Selenium (selenized yeast)
Selenium (selenized yeast) tablets, 300 ug/day
Dietary supplement: Selenium
Selenized yeast, 300 ug/day
Other Names:
  • SelenoPrecise, PharmaNord

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
selenium levels in prostate tissue
Time Frame: after 5 weeks of intervention with selenium or placebo
after 5 weeks of intervention with selenium or placebo
changes in gene expression profiles in prostate tissue
Time Frame: after 5 weeks of intervention with selenium or placebo
after 5 weeks of intervention with selenium or placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in blood flow, vessel permeability and exocrine functionality
Time Frame: after 5 weeks of intervention with selenium or placebo
after 5 weeks of intervention with selenium or placebo
changes in gene expression profiles in blood cells
Time Frame: after 5 weeks of intervention with selenium or placebo
after 5 weeks of intervention with selenium or placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 12, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

March 14, 2011

Last Update Submitted That Met QC Criteria

March 11, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCRF 2004/21
  • CMO nr. 2007/003
  • SePros 2006/02
  • NL14694.091.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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