S0000 Selenium and Vitamin E in Preventing Prostate Cancer

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.

Timeline

Start

2001-07

Primary completion

2011-05

Completion

2012-09

Outcome

Missed primary endpoint

paper Selenium or vitamin E, alone or in combination at the doses and formulations used, did not prevent prostate cancer PMID 19066370 ↗

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• Results 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.
• Results 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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