Lycopene in Preventing Prostate Cancer in Healthy Participants

Prostate Cancer Clinical Trial

Official title:

Mechanism of Prostate Cancer Prevention by Lycopene

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00322114
• Other study ID #: CDR0000468031
• Secondary ID: UIC-2004-0217
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2006
• Last updated: September 19, 2013
• Start date: February 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical 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.

PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• lycopene
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
United States	University of Illinois Cancer Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene			No