Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA090759 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lycopene | Experimental | Lycopene 30 mg/day |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycopene 30mg | Drug | Lycopene 30 mg. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 6 months |
| Changes in Serum Biomarkers | Change in serum lycopene, umol/L | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter H Gann, MD, ScD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Jesse Brown VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8896894 | Background | 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. | |
| 9784387 | Background | 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. doi: 10.1006/bbrc.1998.9351. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lycopene | 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) |
| FG001 | Placebo | 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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lycopene | Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) |
| BG001 | Placebo | Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Not Posted | baseline and 6 months | Participants | |||||||||||
| Primary | Changes in Serum Biomarkers | Change in serum lycopene, umol/L | Posted | Mean | Full Range | umol/L |
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lycopene | Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Cardiac disorders | Patient died four days after randomization from CAD. Patient was on placebo. Event was unrelated to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased urinary frequency | Renal and urinary disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Gann | University of Illinois at Chicago | 312-355-3723 | pgann@uic.edu |
Not provided
| ID | Term |
|---|---|
| D019048 | Prostatic Intraepithelial Neoplasia |
| D011471 | Prostatic Neoplasms |
| D052801 | Male Urogenital Diseases |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077276 | Lycopene |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo |
|
|
| Chicago |
| Illinois |
| 60612 |
| United States |
| 10050865 | Background | 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. doi: 10.1093/jnci/91.4.317. |
| 10578485 | Background | 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. doi: 10.1207/S15327914NC3402_8. |
| 7473833 | Background | 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. doi: 10.1093/jnci/87.23.1767. |
| 9806659 | Background | 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. doi: 10.1002/(sici)1097-0142(19981101)83:93.0.co;2-2. |
| 632120 | Background | Kley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. No abstract available. German. |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. | Not Posted | baseline and 6 months | Participants |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Placebo | Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months) | 1 | 32 | 1 | 32 |
|
| constipation | Gastrointestinal disorders |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D002241 | Carbohydrates |