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

April 1, 2020 updated by: NCIC Clinical Trials Group

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

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

Interventional

Enrollment (Actual)

310

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Masking: Triple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Neil Fleshner, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2001

Primary Completion (Actual)

April 30, 2008

Study Completion (Actual)

April 30, 2008

Study Registration Dates

First Submitted

July 8, 2003

First Submitted That Met QC Criteria

July 8, 2003

First Posted (Estimate)

July 9, 2003

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Prostate Cancer

Clinical Trials on vitamin E

3
Subscribe