Prostate Cancer Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Randomized Study Of Combination Vitamin E, Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial Neoplasia
RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the
development or recurrence of cancer. Vitamin E, selenium, and soy protein may be effective in
preventing the development of prostate cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combining vitamin E,
selenium, and soy protein in preventing prostate cancer in patients who have high-grade
prostate neoplasia.
OBJECTIVES:
- Determine whether nutritional supplementation with soy protein isolate, vitamin E, and
selenium can delay the time to development of invasive prostate cancer (disease-free
survival) in patients with high-grade prostatic intraepithelial neoplasia.
- Determine the effect of this supplementation on intermediate endpoints that may reflect
a lessened risk of invasive prostate cancer (e.g., serum PSA levels, hormone levels,
lycopene, malondialdehyde, vitamin E, and reduced thiol groups) in these patients.
- Determine the safety of this supplementation in these patients.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral vitamin E, oral selenium, and oral soy protein isolate
twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for
3 years in the absence of invasive prostate cancer (demonstrated on biopsy) or
unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 306 patients (153 per treatment arm) will be accrued for this
study within 6 years.
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