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Completed

NCT Number: NCT00006392

S0000 Selenium and Vitamin E in Preventing 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–120 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin E

Drug

400 IU daily by mouth for 7-12 years

Other names: alpha tocopherol

selenium

Drug

200 mcg daily for 7-12 years

Other names: L-selenomethionine

Vitamin E placebo

Other

daily for 7-12 years

Other names: placebo

selenium placebo

Other

daily for 7-12 years

Other names: placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

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

Registry information

Official study title

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

Acronym: SELECT

Important dates

Study start
2001
Primary completion
2011
Study completion
2012
First posted
Jan 27, 2003
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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