The Effects of Lycopene on High Risk Prostatic Tissue

University of Illinois

Status and phase: Completed; Phase 2

Conditions: Intraepithelial Prostatic Neoplasia; Prostatic Neoplasms

Treatments: Drug: Placebo; Drug: Lycopene 30mg

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01443026

R01CA090759 (U.S. NIH Grant/Contract)

2005-0828

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

Lycopene

Experimental group

Description:

Lycopene 30 mg/day

Treatment:

Drug: Lycopene 30mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo