Clinical trial NCT00006392: S0000 Selenium and Vitamin E in Preventing Prostate Cancer
Official title: Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: Eastern Cooperative Oncology Group
name: Cancer and Leukemia Group B
name: NCIC Clinical Trials Group
First posted: 2003-01-27
Enrollment: 35533
Sex: MALE
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Prostate Cancer
timeFrame: Every six months for 7 to 12 years depending on when the participant was randomized.
Secondary outcomes:
measure: Number of Participants With Lung Cancer
timeFrame: 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.
measure: Number of Participants With Colorectal Cancer
timeFrame: 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.
measure: Number of Participants With Any Diagnosis of Cancer
timeFrame: 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.
measure: Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival
timeFrame: 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.
measure: Number of Participants With Serious Cardiovascular Events
timeFrame: 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.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Joliet
country: United States
facility: Midwest Center for Hematology/Oncology
state: Illinois
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center at Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: CCOP - Cancer Research for the Ozarks
state: Missouri
city: Springfield
country: United States
facility: St. John's Regional Health Center
state: Missouri
city: Cincinnati
country: United States
facility: Good Samaritan Hospital Cancer Treatment Center
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
city: Youngstown
country: United States
facility: Tod Children's Hospital
state: Ohio
city: Tulsa
country: United States
facility: LaFortune Cancer Center at St. John Medical Center
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: State College
country: United States
facility: Geisinger Medical Group - Scenery Park
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Knoxville
country: United States
facility: U.T. Cancer Institute at University of Tennessee Medical Center
state: Tennessee
Study officials:
affiliation: The Cleveland Clinic
name: Eric Klein, MD
role: STUDY_CHAIR
affiliation: Duke University
name: Philip J. Walther, MD, PhD
role: STUDY_CHAIR
affiliation: Toronto Sunnybrook Regional Cancer Centre
name: Laurence H. Klotz, MD
role: STUDY_CHAIR
affiliation: MD Anderson
name: Scott M. Lippman, M.D.
role: STUDY_CHAIR
affiliation: University of Texas
name: Ian M. Thompson, M.D.
role: STUDY_CHAIR
affiliation: MAVERIC
name: J. Michael Gaziano, M.D.
role: STUDY_CHAIR
affiliation: Beth Israel Deaconess
name: Daniel D Karp, M.D.
role: STUDY_CHAIR
affiliation: MD Anderson
name: Fadlo R. Khuri, M.D.
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Michael M Lieber, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.