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Phase III Randomized Study of Selenium and Vitamin E for the Prevention of Prostate Cancer (SELECT Trial)
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Related Information
Registry Information
Alternate Title
Selenium and Vitamin E in Preventing Prostate Cancer
Basic Trial Information
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Protocol IDs
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Phase III
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Prevention
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Closed
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55 and over (50 and over for African Americans)
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NCCAM, NCI
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SWOG-S0000
CAN-NCIC-S0000, CALGB-S0000, ECOG-S0000, NCCAM, NCI-P00-0172, NCT00006392, S0000
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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.
- Compare the quality of life of participants treated with these regimens.
- Determine the association of biological molecular markers with the risk of prostate cancer, lung cancer, and colon cancer in these participants.
- Determine the relationship between the effects of these regimens on prostate cancer risk and genetic factors in these participants.
- Determine whether the effects of these regimens on prostate cancer risk are conditional upon pre-study use of these supplements by these participants.
- Determine whether the effects of these regimens are conditional upon intake of other nutrients, foods, and dietary supplements by these participants.
- Determine the effect of other dietary nutrients and dietary patterns on prostate cancer risk in these participants.
- Determine the effects of these regimens on the reduction of Alzheimer's disease incidence in these participants.
- Determine whether these regimens reduce the risk of age-related macular degeneration or cataract in these participants.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery 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)
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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 clopidrogel
- Concurrent anti-hypertension medication
allowed
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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)
Patient Characteristics:
Age: - See Disease Characteristics
Performance status: Life expectancy: Hematopoietic: Hepatic: Renal: 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
Expected Enrollment A total of 32,400 participants (8,100 per prevention arm) will be accrued for
this study within 5 years. Outcomes Primary Outcome(s)Effect on the clinical incidence of cancer
Effect on cancer-free survival, overall survival and serious cardiovascular events
Quality of life
Association of biological molecular markers with cancer risk
Relationship between effects on cancer risk and genetic factors
Effects in terms of intake of other nutrients, foods, and dietary supplements
Effect of other dietary nutrients and dietary patterns on cancer risk
Effects on the reduction of Alzheimer's disease incidence
Reduction in the risk of age-related macular degeneration or cataract
Outline This is a randomized, double-blind, multicenter study. Participants are
randomized to one of four prevention arms. - Arm I: Participants receive 2 different oral placebos once daily.
- Arm II: Participants receive oral selenium and oral placebo once
daily.
- Arm III: Participants receive oral vitamin E and oral placebo once
daily.
- Arm IV: Participants receive oral selenium and oral vitamin E once
daily.
Treatment continues for 7-12 years in the absence of unacceptable
toxicity or diagnosis of prostate cancer. Quality of life is assessed at baseline and then at 1, 3, 5, and 7
years. Participants are followed annually. Published ResultsLippman SM, Klein EA, Goodman PJ, et al.: Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA 301 (1): 39-51, 2009.[PUBMED Abstract] Hoque A, Albanes D, Lippman SM, et al.: Molecular epidemiologic studies within the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Cancer Causes Control 12 (7): 627-33, 2001.[PUBMED Abstract] Related PublicationsCook ED, Moody-Thomas S, Anderson KB, et al.: Minority recruitment to the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Clin Trials 2 (5): 436-42, 2005.[PUBMED Abstract] Kristal AR, King IB, Albanes D, et al.: 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 14 (3): 727-30, 2005.[PUBMED Abstract] Lippman SM, Goodman PJ, Klein EA, et al.: Designing the Selenium and Vitamin E Cancer Prevention Trial (SELECT). J Natl Cancer Inst 97 (2): 94-102, 2005.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group | | | | Eric Klein, MD, Protocol chair | | | |
Eastern Cooperative Oncology Group | | | | Michael Atkins, MD, Protocol chair | | | |
Cancer and Leukemia Group B | | | | Philip Walther, MD, PhD, Protocol chair | | | |
NCIC-Clinical Trials Group | | | | Laurence Klotz, MD, Protocol chair | | | |
Related Information Web site for additional information
| Registry Information | | | Official Title | | Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer | | | Trial Start Date | | 2001-07-25 | | | Registered in ClinicalTrials.gov | | NCT00006392 | | | Date Submitted to PDQ | | 2000-09-11 | | | Information Last Verified | | 2007-09-12 | | | NCI Grant/Contract Number | | CA32102 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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