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

Primary Purpose

Precancerous/Nonmalignant Condition, Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
selenium
soy protein isolate
vitamin E
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Precancerous/Nonmalignant Condition focused on measuring prostate cancer, high grade prostatic intraepithelial neoplasia

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Nova Scotia Cancer Centre
  • Toronto Sunnybrook Regional Cancer Centre
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2003
Last Updated
April 1, 2020
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00064194
Brief Title
Vitamin E, Selenium, and Soy Protein in Preventing Cancer in Patients With High-Grade Prostate Neoplasia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2001 (Actual)
Primary Completion Date
April 30, 2008 (Actual)
Study Completion Date
April 30, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous/Nonmalignant Condition, Prostate Cancer
Keywords
prostate cancer, high grade prostatic intraepithelial neoplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
selenium
Intervention Type
Dietary Supplement
Intervention Name(s)
soy protein isolate
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin E

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Fleshner
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Nova Scotia Cancer Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21537051
Citation
Fleshner NE, Kapusta L, Donnelly B, Tanguay S, Chin J, Hersey K, Farley A, Jansz K, Siemens DR, Trpkov K, Lacombe L, Gleave M, Tu D, Parulekar WR. Progression from high-grade prostatic intraepithelial neoplasia to cancer: a randomized trial of combination vitamin-E, soy, and selenium. J Clin Oncol. 2011 Jun 10;29(17):2386-90. doi: 10.1200/JCO.2010.32.0994. Epub 2011 May 2.
Results Reference
result

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

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