Intraepithelial Prostatic Neoplasia, Prostatic Neoplasms
Conditions
Keywords
Intraepithelial Prostatic Neoplasia, Prostatic neoplasms, Male urogenital disease, Prostate
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.
Interventions
DRUGLycopene 30mg
Lycopene 30 mg.
DRUGPlacebo
Placebo
Sponsors
National Cancer Institute (NCI)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lycopene Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) | 26 |
| Placebo Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) | 32 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Lycopene | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 8.3 | 65.2 years STANDARD_DEVIATION 8.4 | 67.1 years STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 42 Participants | 23 Participants |
| Region of Enrollment United States | 26 participants | 58 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 26 Participants | 58 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 1 / 32 |
| serious Total, serious adverse events | 0 / 26 | 1 / 32 |
Outcome results
Primary
Changes in Serum Biomarkers
Change in serum lycopene, umol/L
Time frame: baseline and 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lycopene | Changes in Serum Biomarkers | .55 umol/L |
| Placebo | Changes in Serum Biomarkers | -0.29 umol/L |
Primary
Tissue Biomarkers
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.
Time frame: baseline and 6 months
Secondary
Changes in Nuclear Morphometry
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.
Time frame: baseline and 6 months