Trial record 1 of 478 for:
SELECT Prostate cancer
S0000 Selenium and Vitamin E in Preventing Prostate Cancer (SELECT)
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| ClinicalTrials.gov Identifier: NCT00006392 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : November 6, 2012
Last Update Posted : November 20, 2015
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Sponsor:
Southwest Oncology Group
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Southwest Oncology Group
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: Vitamin E Drug: Selenium Other: Vitamin E placebo Other: selenium placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 35533 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer |
| Study Start Date : | July 2001 |
| Actual Primary Completion Date : | May 2011 |
| Actual Study Completion Date : | September 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
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Drug: Vitamin E
400 IU daily by mouth for 7-12 years
Other Name: alpha tocopherol Other: selenium placebo daily for 7-12 years
Other Name: placebo |
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Experimental: Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
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Drug: Selenium
200 mcg daily for 7-12 years
Other Name: L-selenomethionine Other: Vitamin E placebo daily for 7-12 years
Other Name: placebo |
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Experimental: Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
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Drug: Vitamin E
400 IU daily by mouth for 7-12 years
Other Name: alpha tocopherol Drug: Selenium 200 mcg daily for 7-12 years
Other Name: L-selenomethionine |
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Placebo Comparator: Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
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Other: Vitamin E placebo
daily for 7-12 years
Other Name: placebo Other: selenium placebo daily for 7-12 years
Other Name: placebo |
Primary Outcome Measures :
- Number of Participants With Prostate Cancer [ Time Frame: Every six months for 7 to 12 years depending on when the participant was randomized. ]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.
Secondary Outcome Measures :
- Number of Participants With Lung Cancer [ Time Frame: 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. ]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.
- Number of Participants With Colorectal Cancer [ Time Frame: 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. ]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.
- Number of Participants With Any Diagnosis of Cancer [ Time Frame: 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. ]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.
- Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival [ Time Frame: 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. ]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.
- Number of Participants With Serious Cardiovascular Events [ Time Frame: 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. ]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.
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| Ages Eligible for Study: | 50 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
DISEASE CHARACTERISTICS:
- Healthy male volunteers
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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)
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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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006392
Locations
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Midwest Center for Hematology/Oncology | |
| Joliet, Illinois, United States, 60432 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Missouri | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65802 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| United States, Ohio | |
| Good Samaritan Hospital Cancer Treatment Center | |
| Cincinnati, Ohio, United States, 45220 | |
| Bethesda North Hospital | |
| Cincinnati, Ohio, United States, 45242 | |
| Tod Children's Hospital | |
| Youngstown, Ohio, United States, 44501 | |
| United States, Oklahoma | |
| LaFortune Cancer Center at St. John Medical Center | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Pennsylvania | |
| Geisinger Medical Center | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| United States, Tennessee | |
| U.T. Cancer Institute at University of Tennessee Medical Center | |
| Knoxville, Tennessee, United States, 37920-6999 | |
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Investigators
| Study Chair: | 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 |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00006392 |
| Obsolete Identifiers: | NCT00076128 |
| Other Study ID Numbers: |
CDR0000068277 S0000 ( Other Identifier: SWOG ) U10CA037429 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | November 6, 2012 |
| Last Update Posted: | November 20, 2015 |
| Last Verified: | October 2015 |
Keywords provided by Southwest Oncology Group:
|
prostate cancer |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Vitamins Vitamin E Tocopherols |
Tocotrienols alpha-Tocopherol Selenium Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Trace Elements |