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

Prostate Cancer Clinical Trial

— SePros  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446901
• Other study ID #: WCRF 2004/21
• Secondary ID: CMO nr. 2007/003
• Status: Completed
• Phase: N/A
• First received: March 12, 2007
• Last updated: March 11, 2011
• Start date: June 2007
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Selenium
Selenized yeast, 300 ug/day

Locations

Country	Name	City	State
Netherlands	University Medical Centre St Radboud	Nijmegen	Gelderland
Netherlands	Wageningen University	Wageningen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	World Cancer Research Fund International

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	selenium levels in prostate tissue		after 5 weeks of intervention with selenium or placebo	No
Primary	changes in gene expression profiles in prostate tissue		after 5 weeks of intervention with selenium or placebo	No
Secondary	changes in blood flow, vessel permeability and exocrine functionality		after 5 weeks of intervention with selenium or placebo	No
Secondary	changes in gene expression profiles in blood cells		after 5 weeks of intervention with selenium or placebo	No