The Effects of Lycopene on High Risk Prostatic Tissue
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lycopene Lycopene 30 mg/day |
Drug: Lycopene 30mg
Lycopene 30 mg.
Other Names:
|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
Placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 2 | Jesse Brown VA Medical Center | Chicago | Illinois | United States | 60612 |
Sponsors and Collaborators
- University of Illinois at Chicago
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Peter H Gann, MD, ScD, University of Illinois at Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
- Bostwick DG, Shan A, Qian J, Darson M, Maihle NJ, Jenkins RB, Cheng L. Independent origin of multiple foci of prostatic intraepithelial neoplasia: comparison with matched foci of prostate carcinoma. Cancer. 1998 Nov 1;83(9):1995-2002.
- Clinton SK, Emenhiser C, Schwartz SJ, Bostwick DG, Williams AW, Moore BJ, Erdman JW Jr. cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol Biomarkers Prev. 1996 Oct;5(10):823-33.
- Giovannucci E, Ascherio A, Rimm EB, Stampfer MJ, Colditz GA, Willett WC. Intake of carotenoids and retinol in relation to risk of prostate cancer. J Natl Cancer Inst. 1995 Dec 6;87(23):1767-76.
- Giovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. Review.
- Jain MG, Hislop GT, Howe GR, Ghadirian P. Plant foods, antioxidants, and prostate cancer risk: findings from case-control studies in Canada. Nutr Cancer. 1999;34(2):173-84.
- Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. German.
- Pastori M, Pfander H, Boscoboinik D, Azzi A. Lycopene in association with alpha-tocopherol inhibits at physiological concentrations proliferation of prostate carcinoma cells. Biochem Biophys Res Commun. 1998 Sep 29;250(3):582-5.
- 2005-0828
- R01CA090759
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lycopene | Placebo |
|---|---|---|
| Arm/Group Description | Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months) | Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months) |
| Period Title: Overall Study | ||
| STARTED | 29 | 37 |
| COMPLETED | 26 | 32 |
| NOT COMPLETED | 3 | 5 |
Baseline Characteristics
| Arm/Group Title | Lycopene | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) | Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) | Total of all reporting groups |
| Overall Participants | 26 | 32 | 58 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.9
(8.3)
|
67.1
(8.1)
|
65.2
(8.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
0
0%
|
0
0%
|
0
0%
|
| Male |
26
100%
|
32
100%
|
58
100%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
3.8%
|
0
0%
|
1
1.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
6
23.1%
|
9
28.1%
|
15
25.9%
|
| White |
19
73.1%
|
23
71.9%
|
42
72.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
26
100%
|
32
100%
|
58
100%
|
Outcome Measures
| Title | Tissue Biomarkers |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Changes in Serum Biomarkers |
|---|---|
| Description | Change in serum lycopene, umol/L |
| Time Frame | baseline and 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lycopene | Placebo |
|---|---|---|
| Arm/Group Description | Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) | Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) |
| Measure Participants | 26 | 32 |
| Mean (Full Range) [umol/L] |
.55
|
-0.29
|
| Title | Changes in Nuclear Morphometry |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Lycopene | Placebo | ||
| Arm/Group Description | Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) | Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) | ||
All Cause Mortality |
||||
| Lycopene | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Lycopene | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 1/32 (3.1%) | ||
| Cardiac disorders | ||||
| death | 0/26 (0%) | 0 | 1/32 (3.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Lycopene | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/26 (0%) | 1/32 (3.1%) | ||
| Gastrointestinal disorders | ||||
| constipation | 0/26 (0%) | 0 | 1/32 (3.1%) | 1 |
| Renal and urinary disorders | ||||
| increased urinary frequency | 0/26 (0%) | 0 | 1/32 (3.1%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Peter Gann |
|---|---|
| Organization | University of Illinois at Chicago |
| Phone | 312-355-3723 |
| pgann@uic.edu |
- 2005-0828
- R01CA090759