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Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00064194
First received: July 8, 2003
Last updated: November 11, 2013
Last verified: March 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
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:


Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: November 2001
Study Completion Date: April 2008
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00064194     History of Changes
Other Study ID Numbers: PRP1, CAN-NCIC-PRP1, CDR0000310096
Study First Received: July 8, 2003
Last Updated: November 11, 2013
Health Authority: Canada: NCIC Clinical Trials Group

Keywords provided by NCIC Clinical Trials Group:
prostate cancer
high grade prostatic intraepithelial neoplasia

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

ClinicalTrials.gov processed this record on November 25, 2014