Prostate CancerPhase 3NCT00978718
Selenium in Preventing Prostate Cancer
A Phase 3 study testing high-selenium baker's yeast and selenium in people with Prostate Cancer, run by University of Arizona.
Trial summary
RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer. Read more about this study
- Who is it for?
- Ages Up to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- high-selenium baker's yeast and selenium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Jun 2004
- Phase
- Phase 3
- 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 Up to 79 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Clinical indicators consistent with the community standards of medical care that would justify a biopsy of the prostate for the diagnosis of cancer, including ≥ 1 of the following:
- PSA level above the absolute value of 4 ng/mL or above a published age-ethnic adjusted PSA level appropriate for the community
- Rising PSA that should represent a clinically significant PSA velocity (e.g., an estimated annual change in the PSA velocity ≥ 0.75 ng/mL)
- Abnormal digital rectal examination of the prostate that identifies a clinically significant change in the prostate (e.g., a prostate nodule or a change in the firmness of the prostate)
- Documentation of the clinical assessment that justified the prostate biopsy that allows classification of the patient to high-risk groups
- Prostate biopsy negative for cancer within the past 12 months
- Prostate biopsy negative for high-grade prostatic intraepithelial neoplasia (PIN)
- PIN allowed provided it is grade 1
PATIENT CHARACTERISTICS:
- Creatinine < 2 times upper limit of normal (ULN)
- Bilirubin < 2 times ULN
- SGOT and SGPT < 2 times ULN
- Alkaline phosphatase < 2 times ULN
- No history of a prior malignancy except for the following:
- Adequately treated basal cell or squamous cell carcinoma
- Adequately treated (i.e., complete surgical removal with negative margins) stage I cancer from which the patient is currently in complete remission
- Any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy or radiotherapy
- At least 90 days since prior and no other concurrent selenium > 55 μg/day as a dietary supplement (including multivitamin supplements)
- More than 30 days since prior and no concurrent participation in any other clinical trial involving a medical, surgical, nutritional, or life-style intervention (e.g., dietary modifications, exercise)
About this study
Official title: Phase III Trial of Selenium for Prostate Cancer Prevention
RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer.
PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.
Read the detailed description
OBJECTIVES:
- To determine whether selenium (Se) supplementation decreases the incidence of prostate cancer.
- To determine whether Se supplementation inhibits the biochemical progression of prostate cancer.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
- Arm II: Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
- Arm III: Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Blood samples are collected at baseline, at randomization, and then semi-annually for laboratory and other testing. Tissue samples may also be collected for biomarker analysis. Patients complete an initial questionnaire and urological-symptoms questionnaire at baseline, a follow-up questionnaire after randomization (to capture new illness, medications, and toxicity symptoms during the 30-day run-in period; a urological-symptoms questionnaire; a food-frequency questionnaire; and a mood questionnaire). Patients then undergo questionnaires semi-annually, including vital status, tablet compliance, nutrition, mood, new illnesses or medications, and any incidence of cancer or family history of cancer).
- Conditions
- Prostate Cancer
- Being tested
- high-selenium baker's yeast, selenium, placebo
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-selenium baker's yeastDietary supplement
Also called selenium
Given orally
seleniumDietary supplement
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Placebo comparator | Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer. Receives: Other: placebo |
| Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily | Experimental | Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer. Receives: Dietary Supplement: selenium |
| Arm III: 400 μg Se as high-Se baker's yeast daily | Experimental | Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer. Receives: Dietary Supplement: high-selenium baker's yeast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of biopsy-proven prostate cancer
Secondary outcomes (2)
Rate of rise in serum PSA levels
Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startAug 2001
- Primary completionJun 2004
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Frederick R. Ahmann, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978718
- Sponsor's protocol ID
- 01-0506-01
- Other IDs
- R01CA077789, P30CA023074, UARIZ-99-0045-01,
- Status last verified
- Aug 2012
- First submitted
- 16 Sep 2009
- Last updated
- 15 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Selenium for Prostate Cancer Prevention
- ClinicalTrials.gov ID
- NCT00978718
- Acronym / sponsor ID
- 01-0506-01
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2001
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 17 Sep 2009 (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.
RATIONALE: Selenium supplements may stop or delay the development of prostate cancer in patients at high risk of prostate cancer. It is not yet known which dose of selenium may be more effective in preventing prostate cancer.
PURPOSE: This randomized phase III trial is studying how well selenium works in preventing prostate cancer.
Detailed description
OBJECTIVES:
- To determine whether selenium (Se) supplementation decreases the incidence of prostate cancer.
- To determine whether Se supplementation inhibits the biochemical progression of prostate cancer.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
- Arm II: Patients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
- Arm III: Patients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer.
Blood samples are collected at baseline, at randomization, and then semi-annually for laboratory and other testing. Tissue samples may also be collected for biomarker analysis. Patients complete an initial questionnaire and urological-symptoms questionnaire at baseline, a follow-up questionnaire after randomization (to capture new illness, medications, and toxicity symptoms during the 30-day run-in period; a urological-symptoms questionnaire; a food-frequency questionnaire; and a mood questionnaire). Patients then undergo questionnaires semi-annually, including vital status, tablet compliance, nutrition, mood, new illnesses or medications, and any incidence of cancer or family history of cancer).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Placebo comparator | Other: placeboPatients receive oral placebo daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer. |
| Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily | Experimental | Dietary Supplement: seleniumPatients receive 200 μg of oral selenium (Se) as high-Se Baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer. |
| Arm III: 400 μg Se as high-Se baker's yeast daily | Experimental | Dietary Supplement: high-selenium baker's yeastPatients receive 400 μg of oral Se as high-Se baker's yeast daily. Treatment continues for up to 57 months in the absence of unacceptable toxicity or diagnosis of prostate cancer. |
Who may qualify
- Ages
- Up to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| high-selenium baker's yeastAlso: seleniumGiven orally | Dietary supplement | Arm III: 400 μg Se as high-Se baker's yeast daily |
| seleniumGiven orally | Dietary supplement | Arm II: 200 μg selenium (Se) as high-Se Baker's yeast daily |
| placeboGiven orally | Other | Arm I |
Primary outcome
Incidence of biopsy-proven prostate cancer
2 secondary outcomes
Rate of rise in serum PSA levels
Evidence of prostate cancer progression as assessed by levels of the serum markers alkaline phosphatase and Chromogranin A
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 15 Aug 2012.
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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.
Frederick R. Ahmann, MD principal investigator
University of Arizona
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing high-selenium baker's yeast and selenium in people with Prostate Cancer, run by University of Arizona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of biopsy-proven prostate cancer. 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 15 Aug 2012.