AzTrials
AzTrials

Prostate CancerPhase 3SELECTNCT00006392

S0000 Selenium and Vitamin E in Preventing Prostate Cancer

A Phase 3 study testing Vitamin E and Selenium in people with Prostate Cancer, run by SWOG Cancer Research Network at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 120 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Vitamin E and Selenium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
35,533 participants
Where
13 sitesUnited States
Study dates
Jul 2001to Sep 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 120 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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)

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Good Samaritan Hospital Cancer Treatment Center

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-0001

  • Midwest Center for Hematology/Oncology

    Joliet, Illinois, 60432

  • U.T. Cancer Institute at University of Tennessee Medical Center

    Knoxville, Tennessee, 37920-6999

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • LaFortune Cancer Center at St. John Medical Center

    Tulsa, Oklahoma, 74104

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Tod Children's Hospital

    Youngstown, Ohio, 44501

Other trials in United States

About this study

Official title: 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.

Read the 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.
Conditions
Prostate Cancer
Being tested
Vitamin E, Selenium, Vitamin E placebo, selenium placebo
Keywords
prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin EDrug

    Also called alpha tocopherol

    400 IU daily by mouth for 7-12 years

  • SeleniumDrug

    Also called L-selenomethionine

    200 mcg daily for 7-12 years

  • Vitamin E placeboOther

    Also called placebo

    daily for 7-12 years

  • selenium placeboOther

    Also called placebo

    daily for 7-12 years

Study groups in NCT00006392
Study groupRoleWhat they receive
Vitamin E + selenium placeboExperimentalvitamin E and selenium placebo daily for 7-12 years
Receives: Drug: Vitamin E; Other: selenium placebo
Selenium + vitamin E placeboExperimentalselenium and vitamin E placebo daily for 7-12 years
Receives: Drug: Selenium; Other: Vitamin E placebo
Vitamin E + seleniumExperimentalvitamin E and selenium placebo daily for 7-12 years
Receives: Drug: Vitamin E; Drug: Selenium
Vitamin E placebo + selenium placeboPlacebo comparatorvitamine E placebo and selenium placebo daily for 7-12 years
Receives: Other: Vitamin E placebo; Other: selenium placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Prostate Cancer

    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.

    Measured: Every six months for 7 to 12 years depending on when the participant was randomized.

Secondary outcomes (5)

  1. Number of Participants With Lung Cancer

    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.

    Measured: 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.

  2. Number of Participants With Colorectal Cancer

    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.

    Measured: 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.

  3. Number of Participants With Any Diagnosis of Cancer

    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.

    Measured: 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.

  4. Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival

    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.

    Measured: 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.

  5. Number of Participants With Serious Cardiovascular Events

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2001
  3. Primary completionMay 2011
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
35,533 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006392
Sponsor's protocol ID
CDR0000068277
Other IDs
S0000, U10CA037429
Acronym
SELECT
Status last verified
Oct 2015
First submitted
4 Oct 2000
Last updated
20 Nov 2015
Data monitoring committee
Yes

Publications

  • Hoque A, Albanes D, Lippman SM, Spitz MR, Taylor PR, Klein EA, Thompson IM, Goodman P, Stanford JL, Crowley JJ, Coltman CA, Santella RM. Molecular epidemiologic studies within the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Cancer Causes Control. 2001 Sep;12(7):627-33. doi: 10.1023/a:1011277600059.

    PubMed 11552710

  • El-Bayoumy K. The negative results of the SELECT study do not necessarily discredit the selenium-cancer prevention hypothesis. Nutr Cancer. 2009;61(3):285-6. doi: 10.1080/01635580902892829. No abstract available.

    PubMed 19373601

  • Cook ED, Moody-Thomas S, Anderson KB, Campbell R, Hamilton SJ, Harrington JM, Lippman SM, Minasian LM, Paskett ED, Craine S, Arnold KB, Probstfield JL. Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Clin Trials. 2005;2(5):436-42. doi: 10.1191/1740774505cn111oa.

    PubMed 16315648

  • Kristal AR, King IB, Albanes D, Pollak MN, Stanzyk FZ, Santella RM, Hoque A. Centralized blood processing for the selenium and vitamin E cancer prevention trial: effects of delayed processing on carotenoids, tocopherols, insulin-like growth factor-I, insulin-like growth factor binding protein 3, steroid hormones, and lymphocyte viability. Cancer Epidemiol Biomarkers Prev. 2005 Mar;14(3):727-30. doi: 10.1158/1055-9965.EPI-04-0596.

    PubMed 15767358

  • Lippman SM, Goodman PJ, Klein EA, Parnes HL, Thompson IM Jr, Kristal AR, Santella RM, Probstfield JL, Moinpour CM, Albanes D, Taylor PR, Minasian LM, Hoque A, Thomas SM, Crowley JJ, Gaziano JM, Stanford JL, Cook ED, Fleshner NE, Lieber MM, Walther PJ, Khuri FR, Karp DD, Schwartz GG, Ford LG, Coltman CA Jr. Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT). J Natl Cancer Inst. 2005 Jan 19;97(2):94-102. doi: 10.1093/jnci/dji009.

    PubMed 15657339

  • Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian LM, Gaziano JM, Hartline JA, Parsons JK, Bearden JD 3rd, Crawford ED, Goodman GE, Claudio J, Winquist E, Cook ED, Karp DD, Walther P, Lieber MM, Kristal AR, Darke AK, Arnold KB, Ganz PA, Santella RM, Albanes D, Taylor PR, Probstfield JL, Jagpal TJ, Crowley JJ, Meyskens FL Jr, Baker LH, Coltman CA Jr. Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2009 Jan 7;301(1):39-51. doi: 10.1001/jama.2008.864. Epub 2008 Dec 9.

    PubMed 19066370

  • Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011 Oct 12;306(14):1549-56. doi: 10.1001/jama.2011.1437.

    PubMed 21990298

  • Vinceti M, Till C, Goodman PJ, Filippini T, Rothman KJ, Thompson IM Jr. The selenium and vitamin E cancer prevention trial (SELECT): a secondary, post-intervention analysis on potential excess chronic disease incidence induced by selenium administration. Am J Epidemiol. 2026 Aug 12:kwag189. doi: 10.1093/aje/kwag189. Online ahead of print.

    PubMed 42581651

  • Tangen CM, Goodman PJ, Till C, Schenk JM, Lucia MS, Thompson IM Jr. Biases in Recommendations for and Acceptance of Prostate Biopsy Significantly Affect Assessment of Prostate Cancer Risk Factors: Results From Two Large Randomized Clinical Trials. J Clin Oncol. 2016 Dec 20;34(36):4338-4344. doi: 10.1200/JCO.2016.68.1965. Epub 2016 Oct 28.

    PubMed 27998216

  • Goodman PJ, Tangen CM, Darke AK, Arnold KB, Hartline J, Yee M, Anderson K, Caban-Holt A, Christen WG, Cassano PA, Lance P, Klein EA, Crowley JJ, Minasian LM, Meyskens FL. Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial. Trials. 2016 Aug 12;17:400. doi: 10.1186/s13063-016-1524-9.

    PubMed 27519183

  • Chan JM, Darke AK, Penney KL, Tangen CM, Goodman PJ, Lee GM, Sun T, Peisch S, Tinianow AM, Rae JM, Klein EA, Thompson IM Jr, Kantoff PW, Mucci LA. Selenium- or Vitamin E-Related Gene Variants, Interaction with Supplementation, and Risk of High-Grade Prostate Cancer in SELECT. Cancer Epidemiol Biomarkers Prev. 2016 Jul;25(7):1050-1058. doi: 10.1158/1055-9965.EPI-16-0104. Epub 2016 May 6.

    PubMed 27197287

  • Abner EL, Dennis BC, Mathews MJ, Mendiondo MS, Caban-Holt A, Kryscio RJ, Schmitt FA; PREADViSE Investigators; Crowley JJ; SELECT Investigators. Practice effects in a longitudinal, multi-center Alzheimer's disease prevention clinical trial. Trials. 2012 Nov 20;13:217. doi: 10.1186/1745-6215-13-217.

    PubMed 23171483

  • Goodman PJ, Hartline JA, Tangen CM, Crowley JJ, Minasian LM, Klein EA, Cook ED, Darke AK, Arnold KB, Anderson K, Yee M, Meyskens FL, Baker LH. Moving a randomized clinical trial into an observational cohort. Clin Trials. 2013 Feb;10(1):131-42. doi: 10.1177/1740774512460345. Epub 2012 Oct 12.

    PubMed 23064404

  • Chlebowski RT, Menon R, Chaisanguanthum RM, Jackson DM. Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial. Clin Trials. 2010 Dec;7(6):744-8. doi: 10.1177/1740774510383886. Epub 2010 Sep 10.

    PubMed 20833684

  • Cook ED, Arnold KB, Hermos JA, McCaskill-Stevens W, Moody-Thomas S, Probstfield JL, Hamilton SJ, Campbell RD, Anderson KB, Minasian LM. Impact of supplemental site grants to increase African American accrual for the Selenium and Vitamin E Cancer Prevention Trial. Clin Trials. 2010 Feb;7(1):90-9. doi: 10.1177/1740774509357227.

    PubMed 20156960

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin E and Selenium in people with Prostate Cancer, run by SWOG Cancer Research Network at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006392, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in