Prostate CancerPhase 2NCT00752739
Selenium in Treating Patients With Prostate Cancer
A Phase 2 study testing selenium in people with Prostate Cancer, run by University of Arizona at 1 site in United States.
Trial summary
RATIONALE: Selenium may prevent or slow the growth of prostate cancer. PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer. Read more about this study
- Who is it for?
- Ages Up to 85 years, men only
- Conditions the study is for
- 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
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Apr 2007
- Phase
- Phase 2
- 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 85 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Biopsy-proven adenocarcinoma of the prostate within the past 48 months
- Prostate-specific antigen < 50 ng/mL
- Gleason score < 8
- Currently undergoing "watchful waiting" for prostate cancer
- No metastatic disease
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 3 years
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 1.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 1.5 times ULN
- No other malignancy within the past 5 years, except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
- No prior hormone therapy, radiotherapy, chemotherapy, or surgery for prostate cancer
- At least 90 days since prior and no concurrent selenium (as a dietary supplement or as part of a multivitamin) exceeding 50 mcg/day
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: Phase II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial)
RATIONALE: Selenium may prevent or slow the growth of prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.
Read the detailed description
OBJECTIVES:
- To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate.
- To investigate the ability of selenium to effectively modulate biomarkers of prostate cancer.
- To determine if selenium modifies the progression of prostate cancer based on an analysis of initial biopsy, subsequent blood biomarkers, and urological symptoms.
- To further establish the safety of chronic supplementation with selenium in these patients.
OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected periodically for biomarker laboratory studies. Blood samples are analyzed for levels of prostate-specific antigen, chromogranin A, alkaline phosphatase, alpha tocopherol, lycopene, and other vitamins; levels of selenium by atomic absorption spectrometry; and oxidative damage to DNA. Tissue samples are analyzed for levels of Bcl-2, p53, Ki-67, thioredoxin reductase, thioredoxin, and glutathione peroxidase by immunohistochemistry and for apoptotic index by TUNEL assay.
Patients complete urological symptom questionnaires and other questionnaires periodically.
- Conditions
- Prostate Cancer
- Being tested
- selenium, placebo
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV 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.
seleniumDietary supplement
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Placebo comparator | Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity. Receives: Other: placebo |
| Arm II | Experimental | Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. Receives: Dietary Supplement: selenium |
| Arm III | Experimental | Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. Receives: Dietary Supplement: selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rise in serum prostate-specific antigen
Rate of rise in chromogranin A and alkaline phosphatase
Disease progression
Secondary outcomes (3)
Time to prostate cancer therapy
Time to metastases
Symptoms of selenium toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2008 (estimated)
- Study startAug 2002
- Primary completionApr 2007
- Study completionApr 2007
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.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 220 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
- NCT00752739
- Sponsor's protocol ID
- 97-0395-01
- Other IDs
- R01CA079080, P30CA023074, UARIZ-97-0395, UARIZ-HSC-97-57, DAMD17-98-1-8580, 97-0395-01
- Status last verified
- Aug 2012
- First submitted
- 12 Sep 2008
- 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 II Chemoprevention Trial of Selenium and Prostate Cancer (Watchful Waiting With Selenium Trial)
- ClinicalTrials.gov ID
- NCT00752739
- Acronym / sponsor ID
- 97-0395-01
- Conditions
- Prostate Cancer
- Keywords
- adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2008 (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 may prevent or slow the growth of prostate cancer.
PURPOSE: This randomized phase II trial is studying how well selenium works in treating patients with prostate cancer.
Detailed description
OBJECTIVES:
- To investigate the ability of selenium to prevent progression in patients with adenocarcinoma of the prostate.
- To investigate the ability of selenium to effectively modulate biomarkers of prostate cancer.
- To determine if selenium modifies the progression of prostate cancer based on an analysis of initial biopsy, subsequent blood biomarkers, and urological symptoms.
- To further establish the safety of chronic supplementation with selenium in these patients.
OUTLINE: Patients are stratified according to Gleason score (low vs moderate). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
- Arm III: Patients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity.
Blood and tissue samples are collected periodically for biomarker laboratory studies. Blood samples are analyzed for levels of prostate-specific antigen, chromogranin A, alkaline phosphatase, alpha tocopherol, lycopene, and other vitamins; levels of selenium by atomic absorption spectrometry; and oxidative damage to DNA. Tissue samples are analyzed for levels of Bcl-2, p53, Ki-67, thioredoxin reductase, thioredoxin, and glutathione peroxidase by immunohistochemistry and for apoptotic index by TUNEL assay.
Patients complete urological symptom questionnaires and other questionnaires periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Placebo comparator | Other: placeboPatients receive oral placebo once daily for 48 months in the absence of disease progression or unacceptable toxicity. |
| Arm II | Experimental | Dietary Supplement: seleniumPatients receive low-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. |
| Arm III | Experimental | Dietary Supplement: seleniumPatients receive high-dose oral selenium once daily for 48 months in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 85 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 |
|---|---|---|
| seleniumGiven orally | Dietary supplement | Arm II, Arm III |
| placeboGiven orally | Other | Arm I |
Primary outcome
Rate of rise in serum prostate-specific antigen
Rate of rise in chromogranin A and alkaline phosphatase
Disease progression
3 secondary outcomes
Time to prostate cancer therapy
Time to metastases
Symptoms of selenium toxicity
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing selenium in people with Prostate Cancer, run by University of Arizona at 1 site in United States.
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.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Rate of rise in serum prostate-specific antigen. The study lists 3 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 15 Aug 2012.