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| ID | Type | Description | Link |
|---|---|---|---|
| CCCWFU-98203 | |||
| CCCWFU-BG03-332 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery.
PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms.
Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation. |
|
| Arm II | Placebo Comparator | Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soy isoflavones | Dietary Supplement | Given orally |
| |
| soy protein isolate |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of pretreatment ER-β expression with response to soy supplementation | after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured. | within 21 days after completetion of supplement regimen |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Scheduled for radical prostatectomy
No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| M. Craig Hall, MD | Wake Forest University Health Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
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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 |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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| Dietary Supplement |
Given orally |
|
| placebo | Other | Given orally |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| 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 |