S0000 Selenium and Vitamin E in Preventing Prostate Cancer (SELECT)
This study is ongoing, but not recruiting participants.
Sponsor:
Southwest Oncology Group
Collaborators:
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00006392
First received: October 4, 2000
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Vitamin E Drug: Selenium Other: Vitamin E placebo Other: selenium placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer |
Resource links provided by NLM:
Drug Information available for:
alpha-Tocopherol
Tocopherol
Selenomethionine
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
U.S. FDA Resources
Further study details as provided by Southwest Oncology Group:
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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 35533 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin E + selenium placebo
vitamin E and selenium placebo daily for 7-12 years
|
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
|
|
Experimental: Selenium + vitamin E placebo
selenium and vitamin E placebo daily for 7-12 years
|
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
|
|
Experimental: Vitamin E + selenium
vitamin E and selenium placebo daily for 7-12 years
|
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
|
|
Placebo Comparator: Vitamin E placebo + selenium placebo
vitamine E placebo and selenium placebo daily for 7-12 years
|
Other: Vitamin E placebo
daily for 7-12 years
Other Name: placebo
Other: selenium placebo
daily for 7-12 years
Other Name: placebo
|
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| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 | |
| Bethesda North Hospital | |
| Cincinnati, Ohio, United States, 45242 | |
| Good Samaritan Hospital Cancer Treatment Center | |
| Cincinnati, Ohio, United States, 45220 | |
| 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
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 | Edmond Odette Cancer Centre at Sunnybrook |
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00006392 History of Changes |
| Obsolete Identifiers: | NCT00076128 |
| Other Study ID Numbers: | CDR0000068277, S0000, U10CA037429 |
| Study First Received: | October 4, 2000 |
| Results First Received: | June 12, 2012 |
| Last Updated: | October 5, 2012 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Southwest Oncology Group:
|
prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Selenium Vitamin E Alpha-Tocopherol Tocopherols |
Tocotrienols Vitamins Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013