S0000 Selenium and Vitamin E in Preventing Prostate Cancer (SELECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006392
First received: October 4, 2000
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known which regimen of selenium and/or vitamin E may be more effective in preventing prostate cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of selenium and vitamin E, either alone or together, in preventing prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: Vitamin E
Drug: Selenium
Other: Vitamin E placebo
Other: selenium placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Number of Participants With Prostate Cancer [ Time Frame: Every six months for 7 to 12 years depending on when the participant was randomized. ] [ Designated as safety issue: No ]
    Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.


Secondary Outcome Measures:
  • Number of Participants With Lung Cancer [ Time Frame: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. ] [ Designated as safety issue: No ]
    Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

  • Number of Participants With Colorectal Cancer [ Time Frame: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. ] [ Designated as safety issue: No ]
    Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

  • Number of Participants With Any Diagnosis of Cancer [ Time Frame: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. ] [ Designated as safety issue: No ]
    Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

  • Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival [ Time Frame: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. ] [ Designated as safety issue: Yes ]
    Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.

  • Number of Participants With Serious Cardiovascular Events [ Time Frame: Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual. ] [ Designated as safety issue: Yes ]
    Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.


Enrollment: 35533
Study Start Date: July 2001
Estimated Study Completion Date: December 2016
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
Drug: Vitamin E
400 IU daily by mouth for 7-12 years
Other Name: alpha tocopherol
Other: selenium placebo
daily for 7-12 years
Other Name: placebo
Experimental: Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
Drug: Selenium
200 mcg daily for 7-12 years
Other Name: L-selenomethionine
Other: Vitamin E placebo
daily for 7-12 years
Other Name: placebo
Experimental: Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
Drug: Vitamin E
400 IU daily by mouth for 7-12 years
Other Name: alpha tocopherol
Drug: Selenium
200 mcg daily for 7-12 years
Other Name: L-selenomethionine
Placebo Comparator: Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
Other: Vitamin E placebo
daily for 7-12 years
Other Name: placebo
Other: selenium placebo
daily for 7-12 years
Other Name: placebo

Detailed Description:

OBJECTIVES:

  • Compare the effect of selenium and vitamin E administered alone vs in combination on the clinical incidence of prostate cancer.
  • Compare the effect of these prevention regimens on the incidence of lung cancer, colorectal cancer, and all cancers combined in participants on this study.
  • Compare the effect of these prevention regimens on prostate cancer-free survival, lung cancer-free survival, colorectal cancer-free survival, cancer-free survival, overall survival, and serious cardiovascular events in these participants.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • Healthy male volunteers
  • Digital rectal examination (DRE) deemed not suspicious for prostate cancer performed within 364 days prior to study entry

    • Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer
  • Total prostate-specific antigen ≤ 4.0 ng/mL within 364 days prior to study entry
  • No prior prostate cancer or high-grade (grade 2-3) prostatic intraepithelial neoplasia

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • Systolic blood pressure < 160 mm Hg
  • Diastolic blood pressure < 90 mm Hg
  • No history of hemorrhagic stroke

Other:

  • No malignancies within the past 5 years except basal cell or squamous cell skin cancer
  • No uncontrolled medical illness
  • No retinitis pigmentosa

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 7 years since prior randomization to SWOG-9217, with completion of end-of-study biopsy requirement
  • No additional concurrent selenium or vitamin E (contained in individual supplements, antioxidant mix, or multivitamin)
  • Concurrent multivitamins allowed (supplied on study)
  • No concurrent anticoagulation therapy (e.g., warfarin)
  • Concurrent prophylactic aspirin (average daily dose no greater than 175 mg/day) allowed

    • Concurrent daily aspirin dose ≤ 81 mg for participants receiving clopidogrel
  • Concurrent anti-hypertension medication allowed
  • No concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only)
  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: NCT00006392

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Ohio
Bethesda North Hospital
Cincinnati, Ohio, United States, 45242
Good Samaritan Hospital Cancer Treatment Center
Cincinnati, Ohio, United States, 45220
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
United States, Oklahoma
LaFortune Cancer Center at St. John Medical Center
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Tennessee
U.T. Cancer Institute at University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920-6999
Sponsors and Collaborators
Southwest Oncology Group
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Investigators
Study Chair: Eric Klein, MD The Cleveland Clinic
Study Chair: Philip J. Walther, MD, PhD Duke University
Study Chair: Laurence H. Klotz, MD Edmond Odette Cancer Centre at Sunnybrook
Study Chair: Scott M. Lippman, M.D. MD Anderson
Study Chair: Ian M. Thompson, M.D. University of Texas
Study Chair: J. Michael Gaziano, M.D. MAVERIC
Study Chair: Daniel D Karp, M.D. Beth Israel Deaconess
Study Chair: Fadlo R. Khuri, M.D. MD Anderson
Study Chair: Michael M Lieber, M.D. Mayo Clinic
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006392     History of Changes
Obsolete Identifiers: NCT00076128
Other Study ID Numbers: CDR0000068277, S0000, U10CA037429
Study First Received: October 4, 2000
Results First Received: June 12, 2012
Last Updated: October 7, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
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 July 26, 2014