Prostate CancerNCT00322114
Lycopene in Preventing Prostate Cancer in Healthy Participants
A study testing lycopene in people with Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- lycopene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2009
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Healthy participants
- No existing prostate disease
PATIENT CHARACTERISTICS:
- Able to supply blood and urine samples
- Able to answer demographic and dietary recall questionnaires
- No hospital inpatients
- Not allergic to tomatoes or tomato products
- Not abusing alcohol or non-prescribed drugs
- No existing gastrointestinal disease or cancer
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior lycopene (in supplement form)
- No concurrent participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612-7243
Clinical Trial Office - University of Illinois Cancer Center, 312-355-3046
About this study
Official title: Mechanism of Prostate Cancer Prevention by Lycopene
RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.
PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.
Secondary
- Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.
- Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.
OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.
- Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
- Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
- Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.
PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- lycopene, 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.
lycopeneDietary supplement
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks. Receives: Dietary Supplement: lycopene |
| Arm II | Experimental | Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks. Receives: Dietary Supplement: lycopene |
| Arm III | Placebo comparator | Participants receive oral placebo twice daily for 3 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2009 (estimated)
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 Illinois ChicagoThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Richard B. van Breemen, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322114
- Sponsor's protocol ID
- CDR0000468031
- Other IDs
- UIC-2004-0217
- Status last verified
- Jul 2009
- First submitted
- 3 May 2006
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Prostate Cancer Prevention by Lycopene
- ClinicalTrials.gov ID
- NCT00322114
- Acronym / sponsor ID
- CDR0000468031
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006
- Primary completion
- Feb 2009 (estimated)
- First posted
- 4 May 2006 (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: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.
PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.
Detailed description
OBJECTIVES:
Primary
- Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.
Secondary
- Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.
- Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.
OUTLINE: This is a randomized, placebo-controlled study. Participants are randomized to 1 of 3 treatment arms.
- Arm I: Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
- Arm II: Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
- Arm III: Participants receive oral placebo twice daily for 3 weeks. Urine and blood samples are collected on days 0, 21, and 42.
PROJECTED ACCRUAL: A total of 150 participants will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: lycopeneParticipants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks. |
| Arm II | Experimental | Dietary Supplement: lycopeneParticipants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks. |
| Arm III | Placebo comparator | Other: placeboParticipants receive oral placebo twice daily for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- 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 |
|---|---|---|
| lycopeneGiven orally | Dietary supplement | Arm I, Arm II |
| placeboGiven orally | Other | Arm III |
Primary outcome
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Richard B. van Breemen, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lycopene in people with Prostate Cancer, run by University of Illinois Chicago 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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene. 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 20 Sep 2013.