S0000 Selenium and Vitamin E in Preventing Prostate Cancer

NCT00006392 | Completed Phase 3 Results DMC

• 3 other identifiers: CDR0000068277S0000U10CA037429
• Study Type: interventional
• Target: 35,533
• Locations: 1 country
• Sites: 13

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

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Number of Participants With Lung Cancer

  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

  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

  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

  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

  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.

Study Arms (4)

Vitamin E + selenium placebo

EXPERIMENTAL

vitamin E and selenium placebo daily for 7-12 years

Drug: Vitamin E; Other: selenium placebo

Selenium + vitamin E placebo

EXPERIMENTAL

selenium and vitamin E placebo daily for 7-12 years

Drug: Selenium; Other: Vitamin E placebo

Vitamin E + selenium

EXPERIMENTAL

vitamin E and selenium placebo daily for 7-12 years

Drug: Vitamin E; Drug: Selenium

Vitamin E placebo + selenium placebo

PLACEBO COMPARATOR

vitamine E placebo and selenium placebo daily for 7-12 years

Other: Vitamin E placebo; Other: selenium placebo

Interventions

Vitamin E DRUG

400 IU daily by mouth for 7-12 years

Also known as: alpha tocopherol

Vitamin E + selenium; Vitamin E + selenium placebo

Selenium DRUG

200 mcg daily for 7-12 years

Also known as: L-selenomethionine

Selenium + vitamin E placebo; Vitamin E + selenium

Vitamin E placebo OTHER

daily for 7-12 years

Also known as: placebo

Selenium + vitamin E placebo; Vitamin E placebo + selenium placebo

selenium placebo OTHER

daily for 7-12 years

Also known as: placebo

Vitamin E + selenium placebo; Vitamin E placebo + selenium placebo

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator
• Cancer and Leukemia Group B: collaborator
• NCIC Clinical Trials Group: collaborator

Study Sites (13)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Midwest Center for Hematology/Oncology

Joliet, Illinois, 60432, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Good Samaritan Hospital Cancer Treatment Center

Cincinnati, Ohio, 45220, United States

Location

Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Tod Children's Hospital

Youngstown, Ohio, 44501, United States

Location

LaFortune Cancer Center at St. John Medical Center

Tulsa, Oklahoma, 74104, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-0001, United States

Location

Geisinger Medical Group - Scenery Park

State College, Pennsylvania, 16801, United States

Location

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

Wilkes-Barre, Pennsylvania, 18711, United States

Location

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

Knoxville, Tennessee, 37920-6999, United States

Location

Related Publications (14)

• 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.

  PMID: 11552710 BACKGROUND

• 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.

  PMID: 19373601 BACKGROUND

• 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.

  PMID: 16315648 BACKGROUND

• 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.

  PMID: 15767358 BACKGROUND

• 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.

  PMID: 15657339 BACKGROUND

• 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.

  PMID: 19066370 RESULT

• 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.

  PMID: 21990298 RESULT

• 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.

  PMID: 27998216 DERIVED

• 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.

  PMID: 27519183 DERIVED

• 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.

  PMID: 27197287 DERIVED

• 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.

  PMID: 23171483 DERIVED

• 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.

  PMID: 23064404 DERIVED

• 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.

  PMID: 20833684 DERIVED

• 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.

  PMID: 20156960 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vitamin E; alpha-Tocopherol; Selenium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols; Chalcogens; Elements; Inorganic Chemicals; Minerals

Results Point of Contact

• Title: Study Statistician
• Organization: SWOG Statistical Center

2066674623

Study Officials

• Eric Klein, MD

  The Cleveland Clinic

  STUDY CHAIR

• Philip J. Walther, MD, PhD

  Duke University

  STUDY CHAIR

• Laurence H. Klotz, MD

  Toronto Sunnybrook Regional Cancer Centre

  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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2000
• First Posted: January 27, 2003
• Study Start: July 1, 2001
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2012
• Last Updated: November 20, 2015
• Results First Posted: November 6, 2012

Record last verified: 2015-10

Locations

US (13)