The Effects of Lycopene on High Risk Prostatic Tissue
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 11/8/2017 |
| Start Date: | February 2006 |
| End Date: | April 2009 |
R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue
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.
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.
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
We found this trial at
2
sites
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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