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

October 23, 2015 updated by: Southwest Oncology Group

Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35533

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Joliet, Illinois, United States, 60432
        • Midwest Center for Hematology/Oncology
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, United States, 45220
        • Good Samaritan Hospital Cancer Treatment Center
      • Youngstown, Ohio, United States, 44501
        • Tod Children's Hospital
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • LaFortune Cancer Center at St. John Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-0001
        • Geisinger Medical Center
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group - Scenery Park
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920-6999
        • U.T. Cancer Institute at University of Tennessee Medical Center

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

50 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

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
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • alpha tocopherol
Other: selenium placebo
daily for 7-12 years
Other Names:
  • 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 Names:
  • L-selenomethionine
Other: Vitamin E placebo
daily for 7-12 years
Other Names:
  • 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 Names:
  • alpha tocopherol
Drug: Selenium
200 mcg daily for 7-12 years
Other Names:
  • L-selenomethionine
Placebo Comparator: Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
Other: selenium placebo
daily for 7-12 years
Other Names:
  • placebo
Other: Vitamin E placebo
daily for 7-12 years
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Prostate Cancer
Time Frame: Every six months for 7 to 12 years depending on when the participant was randomized.
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.
Every six months for 7 to 12 years depending on when the participant was randomized.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Collaborators and Investigators

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

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B

Investigators

  • Study Chair: Eric Klein, MD, The Cleveland Clinic
  • Study Chair: Philip J. Walther, MD, PhD, Duke University
  • 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

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.

General Publications

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

July 1, 2001

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

October 4, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068277
  • U10CA037429 (U.S. NIH Grant/Contract)
  • S0000 (SWOG)

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.

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