Lycopene in Preventing Prostate Cancer in Healthy Participants
- Conditions
- Prostate Cancer
- Interventions
- Dietary Supplement: lycopeneOther: placebo
- Registration Number
- NCT00322114
- Lead Sponsor
- University of Illinois at Chicago
- Brief 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.
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Arm I lycopene Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks. Arm II lycopene Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks. Arm III placebo Participants receive oral placebo twice daily for 3 weeks.
- Primary Outcome Measures
Name Time Method Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States