Nonmalignant NeoplasmNCT00416390
Lycopene in Treating Patients With Prostate Cancer or Benign Prostatic Hyperplasia
A study testing lycopene, laboratory biomarker analysis and biopsy in people with Nonmalignant Neoplasm and Prostate Cancer, run by University of Illinois Chicago.
Trial summary
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Nonmalignant Neoplasm, Prostate Cancer
- What is being tested?
- lycopene, laboratory biomarker analysis and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Mar 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
DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Prostate cancer
- Benign prostate hyperplasia
- High blood levels of prostate-specific antigen
- Enlarged prostate
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: The Effect of Lycopene on DNA Damage in Human Prostate
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.
Read the detailed description
OBJECTIVES:
- Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
- Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
- Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
- Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
- Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
- Measure prostate and blood uptake of the chemoprevention agent lycopene.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral lycopene once daily for 3 weeks.
- Arm II: Patients receive oral placebo once daily for 3 weeks. In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy.
Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
- Conditions
- Nonmalignant Neoplasm, Prostate Cancer
- Being tested
- lycopene, laboratory biomarker analysis, biopsy
- Keywords
- benign prostatic hyperplasia, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lycopeneDietary supplement
laboratory biomarker analysisOther
biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of prostatic tissue to accumulate doses of lycopene
Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing
Effect of lycopene on lipid peroxidation marker malondialdehyde in serum
Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate
Prostate and blood uptake of the chemoprevention agent lycopene
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonmalignant NeoplasmStudies 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
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 120 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
- NCT00416390
- Sponsor's protocol ID
- CDR0000492778
- Other IDs
- UIC-1999-0489
- Status last verified
- Oct 2007
- First submitted
- 27 Dec 2006
- Last updated
- 20 Sep 2013
- Results posted
- No
Publications
van Breemen RB, Sharifi R, Viana M, Pajkovic N, Zhu D, Yuan L, Yang Y, Bowen PE, Stacewicz-Sapuntzakis M. Antioxidant effects of lycopene in African American men with prostate cancer or benign prostate hyperplasia: a randomized, controlled trial. Cancer Prev Res (Phila). 2011 May;4(5):711-8. doi: 10.1158/1940-6207.CAPR-10-0288. Epub 2011 Mar 23.
PubMed 21430075
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
- The Effect of Lycopene on DNA Damage in Human Prostate
- ClinicalTrials.gov ID
- NCT00416390
- Acronym / sponsor ID
- CDR0000492778
- Conditions
- Nonmalignant Neoplasm, Prostate Cancer
- Keywords
- benign prostatic hyperplasia, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Dec 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 substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.
Detailed description
OBJECTIVES:
- Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
- Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
- Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
- Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
- Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
- Measure prostate and blood uptake of the chemoprevention agent lycopene.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral lycopene once daily for 3 weeks.
- Arm II: Patients receive oral placebo once daily for 3 weeks. In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy.
Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- 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 |
|---|---|---|
| lycopene | Dietary supplement | – |
| laboratory biomarker analysis | Other | – |
| biopsy | Procedure or surgery | – |
Primary outcome
Ability of prostatic tissue to accumulate doses of lycopene
Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing
Effect of lycopene on lipid peroxidation marker malondialdehyde in serum
Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate
Prostate and blood uptake of the chemoprevention agent lycopene
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 20 Sep 2013.
- Derived from this study: PubMed 21430075van Breemen RB, Sharifi R, Viana M, Pajkovic N, Zhu D, Yuan L, Yang Y, Bowen PE, Stacewicz-Sapuntzakis M. Antioxidant effects of lycopene in African American men with prostate cancer or benign prostate hyperplasia: a randomized, controlled trial. Cancer Prev Res (Phila). 2011 May;4(5):711-8. doi: 10.1158/1940-6207.CAPR-10-0288. Epub 2011 Mar 23.
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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
Questions about this trial
What is this clinical trial studying?
A study testing lycopene, laboratory biomarker analysis and biopsy in people with Nonmalignant Neoplasm and Prostate Cancer, run by University of Illinois Chicago.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, 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.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Ability of prostatic tissue to accumulate doses of lycopene. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00416390, which also lists 1 linked publication.
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.