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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-3811 | Other Identifier | NCI | |
| NCI-P02-0216 | Other Identifier | NCI | |
| 0105 | Other Identifier | CCOP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups.
PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral isoflavones with multivitamin | Active Comparator | Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. |
|
| Oral lycopene with multivitamin | Active Comparator | Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. |
|
| Multiple vitamin alone | Active Comparator | Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycopene | Dietary Supplement | Daily administration as outlined in treatment arm(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of Treatment Effect on Biomarkers in Each Group | Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of Plasma Level Changes for Each Group | Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention | 4 years |
| Occurrence of Tissue Level Increases |
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DISEASE CHARACTERISTICS:
Histologically confirmed localized prostate cancer
Scheduled prostatectomy between 4-6 weeks after initial biopsy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Nagi B. Kumar, PhD, RD, FADA | H. Lee Moffitt Cancer Center and Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Western Regional, Arizona | Phoenix | Arizona | 85006-2726 | United States | ||
| H. Lee Moffitt Cancer Center and Research Institute |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077276 | Lycopene |
| C067316 | Geritol |
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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| Multivitamin | Dietary Supplement | Daily administration as outlined in treatment arm(s) |
|
| Soy isoflavones | Dietary Supplement | Daily administration as outlined in treatment arm(s) |
|
Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention
| 4 years |
| Occurrences of Disease Progression for Each Group | Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention | 4 years |
| Occurrences of Hormonal Effect | Effect of isoflavones and lycopene on serum steroid hormones as measured by sex-hormone-binding globulin, estradiol, and free testosterone at baseline and post-study intervention | 4 years |
| Tampa |
| Florida |
| 33612-9497 |
| United States |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah | Georgia | 31405-6015 | United States |
| CCOP - MeritCare Hospital | Fargo | North Dakota | 58122 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital 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 |
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
| D004044 | Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |