Lycopene in Preventing Prostate Cancer in Healthy Participants

University of Illinois

Status: Unknown

Conditions: Prostate Cancer

Treatments: Dietary Supplement: lycopene; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00322114

CDR0000468031

UIC-2004-0217

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 design

150 participants in 3 patient groups, including a placebo group

Arm I

Experimental group

Description:

Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.

Treatment:

Dietary Supplement: lycopene

Arm II

Experimental group

Description:

Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.

Treatment:

Dietary Supplement: lycopene

Arm III

Placebo Comparator group

Description:

Participants receive oral placebo twice daily for 3 weeks.

Treatment:

Other: placebo