Prostatic NeoplasmsSeProsNCT00446901
Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
A study testing Selenium in people with Prostatic Neoplasms and Prostate Cancer, run by Wageningen University at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer
- What is being tested?
- Selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jun 2007to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- male
- biopsy proven prostate cancer
- scheduled for radical prostatectomy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
University Medical Centre St Radboud
Nijmegen, Gelderland, 6500 HB
Wageningen University
Wageningen, Gelderland, 6700 EV
About this study
The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.
Read the 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.
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Being tested
- Selenium
- Keywords
- Prostate Cancer, Selenium, Chemoprevention, Gene expression
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeleniumDietary supplement
Also called SelenoPrecise, PharmaNord
Selenized yeast, 300 ug/day
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Selenium |
| Selenium (selenized yeast) | Experimental | Selenium (selenized yeast) tablets, 300 ug/day Receives: Dietary Supplement: Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
selenium levels in prostate tissue
Measured: after 5 weeks of intervention with selenium or placebo
changes in gene expression profiles in prostate tissue
Measured: after 5 weeks of intervention with selenium or placebo
Secondary outcomes (2)
changes in blood flow, vessel permeability and exocrine functionality
Measured: after 5 weeks of intervention with selenium or placebo
changes in gene expression profiles in blood cells
Measured: after 5 weeks of intervention with selenium or placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- World Cancer Research Fund International
- Investigators
- J.A. Witjes, Md PhD Prof, Study chair, University Medical Center St RadboudL.A.L.M. Kiemeney, PhD Prof, Study chair, University Medical Center St RadboudP. van 't Veer, PhD Prof, Study chair, Wageningen UniversityL.A. Afman, PhD, Study chair, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446901
- Sponsor's protocol ID
- WCRF 2004/21
- Other IDs
- CMO nr. 2007/003, SePros 2006/02, NL14694.091.07
- Acronym
- SePros
- Status last verified
- Mar 2011
- First submitted
- 12 Mar 2007
- Last updated
- 14 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium and Prostate Cancer: Clinical Trial on Availability to Prostate Tissue and Effects on Gene Expression
- ClinicalTrials.gov ID
- NCT00446901
- Acronym / sponsor ID
- SePros / WCRF 2004/21
- Conditions
- Prostatic Neoplasms, Prostate Cancer
- Keywords
- Prostate Cancer, Selenium, Chemoprevention, Gene expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- World Cancer Research Fund International
- Study start
- Jun 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether selenium supplementation leads to changes in selenium levels and gene expression profiles in prostate tissue.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: SeleniumPlacebo |
| Selenium (selenized yeast) | Experimental | Dietary Supplement: SeleniumSelenium (selenized yeast) tablets, 300 ug/day |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- male
- biopsy proven prostate cancer
- scheduled for radical prostatectomy
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeleniumAlso: SelenoPrecise, PharmaNordSelenized yeast, 300 ug/day | Dietary supplement | Placebo, Selenium (selenized yeast) |
Primary outcome
selenium levels in prostate tissue
Time frame: 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
2 secondary outcomes
changes in blood flow, vessel permeability and exocrine functionality
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.A. Witjes, Md PhD Prof study chair
University Medical Center St Radboud
L.A.L.M. Kiemeney, PhD Prof study chair
University Medical Center St Radboud
P. van 't Veer, PhD Prof study chair
Wageningen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selenium in people with Prostatic Neoplasms and Prostate Cancer, run by Wageningen University at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
selenium levels in prostate tissue (time frame: after 5 weeks of intervention with selenium or placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2011.