Lycopene in Preventing Prostate Cancer in Healthy Participants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mechanism of Prostate Cancer Prevention by Lycopene

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: lycopene
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks. | Dietary Supplement: lycopene<br>* Given orally<br>|
| Experimental: Arm II<br>Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks. | Dietary Supplement: lycopene<br>* Given orally<br>|
| Placebo Comparator: Arm III<br>Participants receive oral placebo twice daily for 3 weeks. | Other: placebo<br>* Given orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer