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

This study has been completed.
Sponsor:
Collaborator:
World Cancer Research Fund International
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00446901
First received: March 12, 2007
Last updated: March 11, 2011
Last verified: March 2011

March 12, 2007
March 11, 2011
June 2007
January 2011   (final data collection date for primary outcome measure)
  • selenium levels in prostate tissue [ Time Frame: after 5 weeks of intervention with selenium or placebo ] [ Designated as safety issue: No ]
  • changes in gene expression profiles in prostate tissue [ Time Frame: after 5 weeks of intervention with selenium or placebo ] [ Designated as safety issue: No ]
  • selenium levels in prostate tissue
  • changes in gene expression profiles in prostate tissue
Complete list of historical versions of study NCT00446901 on ClinicalTrials.gov Archive Site
  • changes in blood flow, vessel permeability and exocrine functionality [ Time Frame: after 5 weeks of intervention with selenium or placebo ] [ Designated as safety issue: No ]
  • changes in gene expression profiles in blood cells [ Time Frame: after 5 weeks of intervention with selenium or placebo ] [ Designated as safety issue: No ]
  • changes in blood flow, vessel permeability and exocrine functionality
  • changes in gene expression profiles in blood cells
Not Provided
Not Provided
 
Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression

The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Prostatic Neoplasms
  • Prostate Cancer
Dietary Supplement: Selenium
Selenized yeast, 300 ug/day
Other Name: SelenoPrecise, PharmaNord
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Dietary Supplement: Selenium
  • Experimental: Selenium (selenized yeast)
    Selenium (selenized yeast) tablets, 300 ug/day
    Intervention: Dietary Supplement: Selenium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00446901
WCRF 2004/21, CMO nr. 2007/003, SePros 2006/02, NL14694.091.07
No
Wageningen University
Wageningen University
World Cancer Research Fund International
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
Wageningen University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP