S0000 Selenium and Vitamin E in Preventing Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT00006392
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 35533
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Vitamin E + selenium placebo Vitamin E vitamin E and selenium placebo daily for 7-12 years Vitamin E + selenium placebo selenium placebo vitamin E and selenium placebo daily for 7-12 years Selenium + vitamin E placebo Vitamin E placebo selenium and vitamin E placebo daily for 7-12 years Vitamin E placebo + selenium placebo selenium placebo vitamine E placebo and selenium placebo daily for 7-12 years Vitamin E placebo + selenium placebo Vitamin E placebo vitamine E placebo and selenium placebo daily for 7-12 years Selenium + vitamin E placebo Selenium selenium and vitamin E placebo daily for 7-12 years Vitamin E + selenium Vitamin E vitamin E and selenium placebo daily for 7-12 years Vitamin E + selenium Selenium vitamin E and selenium placebo daily for 7-12 years
- Primary Outcome Measures
Name Time Method Number of Participants With Prostate Cancer 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
Name Time Method Number of Participants With Lung Cancer 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 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 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 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 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.
Related Research Topics
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Trial Locations
- Locations (13)
Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Good Samaritan Hospital Cancer Treatment Center
🇺🇸Cincinnati, Ohio, United States
Tod Children's Hospital
🇺🇸Youngstown, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
LaFortune Cancer Center at St. John Medical Center
🇺🇸Tulsa, Oklahoma, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
🇺🇸Chicago, Illinois, United States
Midwest Center for Hematology/Oncology
🇺🇸Joliet, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Geisinger Medical Group - Scenery Park
🇺🇸State College, Pennsylvania, United States
U.T. Cancer Institute at University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States