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…
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Besides gene expression profiles in prostate tissue, also gene expression
profiles of peripheral mononuclear cells, levels of selenium in blood and
toenails and blood flow and permeability of blood vessels of prostate tissue
will be analyzed to examine the biological effects of selenium supplementation.
Background summary
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 supposed that selenium (among other
effects) directly affects gene expression in the prostate.
Study 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. Baseline blood samples, questionnaires,
MRI images and surgical specimens will be collected to examine effects of
selenium supplementation.
Intervention
Participants will receive (dietary supplement) 300 ug selenium / day or a
placebo. Selenium will be provided in the form of selenized yeast tablets
(SelenoPrecise, Pharma Nord) during 5 weeks prior to radical prostatectomy.
Study burden and risks
Risk and burden associated with the present study will be comparable to the
standard medical treatment. The participants will be asked to fill in
questionnaires concerning personal characteristics, medical history and dietary
habits. Participants will take dietary supplements or a placebo for a total
period of 5 weeks, and will have two additional prostate biopsies and one
additional MRI scan. Other procedures related to the participant will be
according to the normal protocol of the department of Urology or Radiology.
Postbus 8129
6700 EV Wageningen
Nederland
Postbus 8129
6700 EV Wageningen
Nederland
Listed location countries
Age
Inclusion criteria
Male
Caucasian ethnicity
Biopsy-proven prostate cancer
Scheduled for radical prostatectomy
Exclusion criteria
Adjuvant therapy for prostate cancer (e.g. HIFU, hormonal therapy)
Use of dietary supplements
Previously or concurrent diagnosed with cancer (other than prostate cancer)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00446901 |
| CCMO | NL14694.091.07 |