Clinical Trials
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- (This trial is currently CLOSED)
Authors: National Cancer Institute, NCI and the South West Oncology
Group
Time
Frame: 7/25/01 to 7/25/13
Aims:
Study Purpose: The purpose of this study is to compare the effects (good
and bad) of selenium (L-selenomethionine), vitamin E (alpha-tocopherol),
selenium plus vitamin E, and placebo (a pill containing no active substances).
We want to see whether the supplements, other than the placebo, can
prevent or reduce the occurrence of prostate cancer. Prostate cancer
is the cancer (aside from skin cancer) found most often in U.S. men
The main
purpose of this trial is to learn more about prostate cancers in healthy
men that are found as part of regular medical care. We want to know
whether the study supplements can prevent or decrease these cancers.
Study
subjects and method of recruitment: About 32,400 male subjects will
be enrolled in this study for a time period of 7 to 12 years. All eligible
patients treated at the Columbia Presbyterian Medical Center will be
offered participation in this study.
Study procedures: This study has four study groups and participants
will be randomized to one of the four groups. One group will receive
two placebos (no active medication), a second group will receive selenium
and a placebo for vitamin E, another will receive vitamin E and a placebo
for selenium, and the fourth group will receive selenium and vitamin
E. One placebo pill will look and taste the same as the selenium pill,
and the other placebo pill will look and taste the same as the vitamin
E pill.