Status:
COMPLETED
The Effects of Lycopene on High Risk Prostatic Tissue
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraepithelial Prostatic Neoplasia
Prostatic Neoplasms
Eligibility:
MALE
40+ years
Phase:
PHASE2
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 prost...
Eligibility Criteria
Inclusion
- 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
- No repeat biopsy planned
- Not willing to change diet
- Have a diagnosis of prostate cancer
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT01443026
Start Date
February 1 2006
End Date
April 1 2009
Last Update
November 19 2019
Active Locations (2)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
Jesse Brown VA Medical Center
Chicago, Illinois, United States, 60612