- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00064194
Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V7
- Nova Scotia Cancer Centre
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-
Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Masking: Triple
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Neil Fleshner, Princess Margaret Hospital, Canada
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Male
- Prostatic Diseases
- Carcinoma in Situ
- Neoplasms
- Prostatic Neoplasms
- Precancerous Conditions
- Prostatic Intraepithelial Neoplasia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Trace Elements
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin E
- Selenium
Other Study ID Numbers
- PRP1
- CAN-NCIC-PRP1 (Other Identifier: PDQ)
- CDR0000310096 (Other Identifier: PDQ)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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