The Effects of Lycopene on High Risk Prostatic Tissue

Phase 2

Completed

• Conditions: Prostatic Neoplasms; Intraepithelial Prostatic Neoplasia
• Interventions: Drug: Lycopene 30mg; Drug: Placebo

• Registration Number: NCT01443026
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-29
• Results First Submitted: 2014-04-17
• Results First Submitted QC: 2015-06-02
• Results First Posted: 2015-06-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-15
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Male
• Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
• Have an AUA symptom score <=25 at time of registration.
• Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
• Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
• Be willing to limit intake of lycopene-containing foods while on study
• Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
• Be ambulatory, capable of self-care and able to carry out light or sedentary work
• Have a dietary fat intake of 23-48% of calories
• Participant's physician recommends repeat biopsy 4-6 months after randomization

Exclusion Criteria

• No repeat biopsy planned
• Not willing to change diet
• Have a diagnosis of prostate cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lycopene	Lycopene 30mg	Lycopene 30 mg/day
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Tissue Biomarkers	baseline and 6 months	We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.
Changes in Serum Biomarkers	baseline and 6 months	Change in serum lycopene, umol/L

Secondary Outcome Measures

Name	Time	Method
Changes in Nuclear Morphometry	baseline and 6 months	We will use a computerized image analysis system designed for the chemoprevention setting to test the hypothesis that the antioxidants cause a favorable change in a nuclear morphometry index based on nuclear size, shape and chromatin texture.

Trial Locations

Locations (2)

Jesse Brown VA Medical Center; 🇺🇸 Chicago, Illinois, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States