Trial record 1 of 1 for:    NCT00006392
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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

October 4, 2000
October 7, 2013
July 2001
May 2011   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00006392 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
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S0000 Selenium and Vitamin E in Preventing Prostate Cancer
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Prostate Cancer
  • 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
  • Other: Vitamin E placebo
    daily for 7-12 years
    Other Name: placebo
  • Other: selenium placebo
    daily for 7-12 years
    Other Name: placebo
  • Experimental: Vitamin E + selenium placebo
    vitamin E and selenium placebo daily for 7-12 years
    Interventions:
    • Drug: Vitamin E
    • Other: selenium placebo
  • Experimental: Selenium + vitamin E placebo
    selenium and vitamin E placebo daily for 7-12 years
    Interventions:
    • Drug: Selenium
    • Other: Vitamin E placebo
  • Experimental: Vitamin E + selenium
    vitamin E and selenium placebo daily for 7-12 years
    Interventions:
    • Drug: Vitamin E
    • Drug: Selenium
  • Placebo Comparator: Vitamin E placebo + selenium placebo
    vitamine E placebo and selenium placebo daily for 7-12 years
    Interventions:
    • Other: Vitamin E placebo
    • Other: selenium placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35533
December 2016
May 2011   (final data collection date for primary outcome measure)

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)
Male
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006392
CDR0000068277, S0000, U10CA037429
Yes
Southwest Oncology Group
Southwest Oncology Group
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
  • Cancer and Leukemia Group B
  • NCIC Clinical Trials Group
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
Southwest Oncology Group
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP