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

Sponsor:	NCIC Clinical Trials Group
Information provided by:	NCIC Clinical Trials Group
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:	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:

MedlinePlus related topics: Cancer Prostate Cancer Vitamin E

Drug Information available for: alpha-Tocopherol DL-alpha-Tocopherol Vitamin E Tocopherols Selenomethionine Tocotrienol Selenium Proteins, soy

U.S. FDA Resources

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

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

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 7, 2010
Health Authority:	United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:

prostate cancer
high grade prostatic intraepithelial neoplasia

Additional relevant MeSH terms:

Neoplasms
Disease
Precancerous Conditions
Prostatic Neoplasms
Prostatic Intraepithelial Neoplasia
Carcinoma in Situ
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Selenium
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012