Status: Closed
Activation Date: 2001NOV28
Closing Date: 2004JUL23
Phase: III
Description: A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia
Eligibility: Documented high grade prostatic intraepithelial neoplasia (HGPIN) confirmed by the central reference pathologist. Two prostate biopsies performed within 18 months of randomization with the most recent within 6 months of randomization. Both biopsies must be negative for invasive prostate cancer.
Objective: To compare disease free survival, changes in serum PSA, oxidative biomarkers and hormone levels with nutrient supplement, containing vitamin E, selenium and soy protein, or placebo. To determine the association between prostate cancer development and exposure to various hypothesized risk factor for prostate cancer and to evaluate the safety of the treatment.
Participation: Not limited
Lay Description: The purpose of this study is to see if soybean product plus vitamin E and selenium can prevent the development of prostate cancer in men with PIN cells. To do this, half of the subjects in the study will receive a nutritional supplement containing soybean product, vitamin E and selenium and the other half will receive a placebo (a substance that does not do anything).
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| GENITO-URINARY | PRP1 | 303 | 3 | 28 | 30 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| GENITO-URINARY | PRP1 | 303 | 1 | 1 |
| Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
| GENITO-URINARY | PRP1 | 303 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |