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Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
This study is ongoing, but not recruiting participants.
First Received: July 8, 2003   Last Updated: February 6, 2009   History of Changes
Sponsor: NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00064194
  Purpose

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.


Condition Intervention Phase
Precancerous/Nonmalignant Condition
Prostate Cancer
 Dietary Supplement: selenium
Dietary Supplement: soy protein isolate
Dietary Supplement: vitamin E
 Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets Prostate Cancer
Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Vitamin E Tocopherols Tocotrienol Selenium Proteins, soy
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 2001
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00064194

Locations
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Neil Fleshner Princess Margaret Hospital, Canada
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000310096, CAN-NCIC-PRP1
Study First Received: July 8, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00064194     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
prostate cancer
high grade prostatic intraepithelial neoplasia

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Genital Neoplasms, Male
Precancerous Conditions
Physiological Effects of Drugs
Urogenital Neoplasms
Tocopherols
Selenium
Neoplasms by Site
Carcinoma in Situ
Vitamins
Tocotrienols
Micronutrients
 Prostatic Intraepithelial Neoplasia
Tocopherol acetate
Neoplasms by Histologic Type
Growth Substances
Trace Elements
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Carcinoma
Alpha-Tocopherol
Neoplasms
Vitamin E
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009



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