Selenium in Preventing Cancer in Patients With Neoplasia of the Prostate - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group Cancer and Leukemia Group B
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030901

Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of selenium may be an effective way to prevent prostate cancer in patients who have neoplasia of the prostate.

PURPOSE: Randomized phase III trial to study the effectiveness of selenium in preventing prostate cancer in patients who have neoplasia of the prostate.

Condition	Intervention	Phase
Precancerous/Nonmalignant Condition Prostate Cancer	Dietary Supplement: selenium	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	L-Selenium-Based Chemoprevention Of Prostate Cancer Among Men With High Grade Prostatic Intraepithelial Neoplasia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Selenium

U.S. FDA Resources

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

Primary Outcome Measures:

Presence or absence of carcinoma of the prostate as measured by biopsy [ Designated as safety issue: No ]

Estimated Enrollment:	465
Study Start Date:	February 2000

Detailed Description:

OBJECTIVES:

Compare the effects of selenium versus placebo on the 3-year incidence rate of prostate cancer in patients with high-grade prostatic intraepithelial neoplasia.
Compare the toxicity of these regimens in these patients.
Compare the effects of these regimens on the rate of increase in prostate-specific antigen (PSA) in these patients.
Compare the effects of these regimens on prostatic cellular proliferation and apoptosis, degradation of basal cell integrity of prostatic ducts, and changes in nuclear chromatin patterns in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (40-60 vs 61 and over), race (African American vs other), baseline PSA (less than 4 ng/mL vs 4-10 ng/mL), concurrent vitamin E supplementation (yes vs no), and cores obtained from initial biopsy (10 or more vs less than 10). Patients are randomized to 1 of 2 arms.

Arm I: Patients receive oral selenium once daily.
Arm II: Patients receive oral placebo once daily. Treatment in both arms continues for 3 years in the absence of progression to prostate cancer or unacceptable toxicity.

Patients are followed every 6 months for 2 years and then annually for 8 years.

PROJECTED ACCRUAL: A total of 465 patients will be randomized for this study.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of high-grade prostatic intraepithelial neoplasia with no evidence of cancer
- Documented by a digital rectal exam and biopsy of the prostate with transrectal ultrasound guidance (required if fewer than 6 cores obtained in biopsy) meeting one of the following conditions:
  - Biopsy yielded fewer than 10 cores within the past 24 months OR yielded more than 10 cores 6-24 months before study
  - Biopsy yielded 10 or more cores within the past 6 months
PSA ≤ 10 ng/mL (≤ 5 ng/mL for patients who have received finasteride or other androgen suppressor within the past 2 months)
American Urological Association symptom score of less than 20

PATIENT CHARACTERISTICS:

Age:

40 and over

Performance status:

SWOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated stage I or II cancer that is in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

See Disease Characteristics
No concurrent finasteride or any other androgen suppressor

Radiotherapy

Not specified

Surgery

Not specified

Other

At least 30 days since prior daily dietary supplements containing 50 micrograms or more of selenium
No concurrent daily dietary supplements containing more than 50 micrograms of selenium

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030901

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Cancer and Leukemia Group B

Investigators

Study Chair:	Jim Marshall, PhD	Roswell Park Cancer Institute
Study Chair:	David Jarrard, MD	University of Wisconsin, Madison
Study Chair:	W. Robert Lee, MD	Wake Forest University

More Information

Additional Information:

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

Featured trial article This link exits the ClinicalTrials.gov site

Publications:

Marshall JR, Sakr W, Wood D, Berry D, Tangen C, Parker F, Thompson I, Lippman SM, Lieberman R, Alberts D, Jarrard D, Coltman C, Greenwald P, Minasian L, Crawford ED. Design and progress of a trial of selenium to prevent prostate cancer among men with high-grade prostatic intraepithelial neoplasia. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1479-84.

Sakr WA, Faulkner JR, Wood D: Low rate of confirming prostate cancer on repeat biopsies following diagnosis of high grade prostatic intraepithelial neoplasia: preliminary analysis of Southwest Oncology Group study s9917. [Abstract] Proceedings of the American Association for Cancer Research 45: A-1333, 305, 2004.

Study ID Numbers:	CDR0000069210, SWOG-S9917, CALGB-70004, ECOG-SWOG-S9917, NCI-P02-0203
Study First Received:	February 14, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00030901 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

prostate cancer
high grade prostatic intraepithelial neoplasia

Study placed in the following topic categories:

Prostatic Intraepithelial Neoplasia
Antioxidants
Precancerous Conditions
Genital Neoplasms, Male
Prostatic Diseases
Urogenital Neoplasms
Trace Elements

Genital Diseases, Male
Carcinoma
Selenium
Carcinoma in Situ
Micronutrients
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Prostatic Intraepithelial Neoplasia
Antioxidants
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Genital Neoplasms, Male
Prostatic Diseases
Growth Substances
Physiological Effects of Drugs
Trace Elements
Urogenital Neoplasms

Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Carcinoma
Selenium
Neoplasms
Neoplasms by Site
Carcinoma in Situ
Micronutrients
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 02, 2009