A Double-Blind, Placebo-Controlled, Randomized Study Of Combination Vitamin E, Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial Neoplasia
N/A
N/A
Male
Precancerous/Nonmalignant Condition, Prostate Cancer
Trial Information
A Double-Blind, Placebo-Controlled, Randomized Study Of Combination Vitamin E, Selenium And Soy Protein Product In Subjects With High Grade Prostatic Intraepithelial 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed high-grade prostatic intraepithelial neoplasia (HGPIN)
- No evidence of invasive prostate cancer by at least 2 biopsies within the past
18 months
- At least 1 biopsy must show evidence of HGPIN within the past 6 months
- No prior invasive prostate cancer
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Not specified
Life expectancy
- More than 5 years
Hematopoietic
- Platelet count at least 75,000/mm^3
- No coagulopathies
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- PT (INR) no greater than 1.5 times ULN
- PTT no greater than 1.5 times ULN
- No hepatic insufficiencies
Renal
- Creatinine no greater than 2 times ULN
- No renal insufficiencies
Other
- No prior nonmelanoma skin cancer (e.g., squamous cell or basal cell carcinoma)
- No other malignancy within the past 5 years except superficial bladder cancer
- No known bowel malabsorption
- No dietary behavior (e.g., morbid obesity or eating disorders) that would limit
adherence to study therapy
- No major illness, including psychiatric illness, that would preclude study compliance
and follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- More than 3 months since prior androgen therapy
- More than 3 months since prior hormonal therapy for benign prostatic hyperplasia
(e.g., finasteride)
- No concurrent finasteride
- No concurrent androgen therapy
Radiotherapy
- More than 2 years since prior radiotherapy to the pelvic region
Surgery
- Not specified
Other
- More than 2 weeks since prior supplemental vitamin E or selenium
- No other concurrent vitamin E (greater than 100 IU/day), selenium, or soy protein
isolate (more than 2 servings/week)
- No other concurrent treatment for high-grade prostatic intraepithelial neoplasia
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
Principal Investigator
Neil Fleshner
Investigator Role:
Study Chair
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
United States: Federal Government
Study ID:
PRP1
NCT ID:
NCT00064194
Start Date:
November 2001
Completion Date:
April 2008
Related Keywords:
- Precancerous/Nonmalignant Condition
- Prostate Cancer
- prostate cancer
- high grade prostatic intraepithelial neoplasia
- Neoplasms
- Precancerous Conditions
- Prostatic Neoplasms
- Prostatic Intraepithelial Neoplasia
- Carcinoma in Situ
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