In This SectionTexas Health Research & Education Institute
Disease or Condition
SELENIUM AND VITAMIN E CANCER PREVENTION TRIAL (SELECT) (Prostate Cancer)
The main purpose of this study is to learn if taking supplements with selenium or vitamin E or both can prevent prostate cancer.
Participants must be male, age 55 or older. African American men must be age 50 or older.
Particioants must have a digital rectal examination (DRE) deemed NOT SUSPICIOUS FOR PROSTATE CANCER in the judgement of the examiner. Participants with a suspicious DRE are ineligible even if a recent or subsequent biopsy is negative for cancer. The non-suspicious DRE must be preformed less than or equal to 364 days prior to randomization.
Participants must have a Total PSA of equal to or less than 4.0 ng/ml less than 364 days prior to randomization:
a. If the participant will be randomized less than 60 days after his final Total PSA test for PCPT (typically contact 80), the results of the PSA MUST be used in determining eligibility. A report of "Not Elevated" meets the PSA eligibility requirement. Do no further PSA testing for eligibility.
b. If the participnat will be randomized 61-364 days after his final Total PSA test for PCPT (typically contact 80), the investigator MAY choose to use either the results of that PSA (with a report "Not Elevated) or a new Total PSA test of less than or equal to 364 days prior to randomization with the results of less than or equal to 4.0 ng/ml for eligibility.
Individuals previously diagnosed with prostate cancer or high grade (Grade2-3) Prostatic Intraepithelial Neoplasia (PIN) are ineligible. (For previous PCPT participants, the diagnossis of prostate cancer or high grade [Grade 2-3] PIN by either the pathology Core Labarotory OR by thelocal pathologist would render the potential participant ineligible).
Individuals are ineligible if they have a prior history of malignancies other than basal or squamous cell carcinoma of th eskin within the past five years. Individuals are eligible if they have had a prior malignancy but have had no evidence of disease for at least five years prior to randomization.
Participants must be randomized equal to or greater than 28 and equal to or less than 90 days after the inital visit (inital visit is considered Day 0).
Participants must not b e currently taking (on day of randomization) or palning to take the following in addition to study supplements: Any vitamin E, any selenium.
Individuals currently receiveng anticoagulation therapy(e.g., wafarin) are ineligible. Individuals taking asprin for coagualtion prophlaxis or for any other reason, must exceed an average daily dose of 175 mg/day. If potential participants are alos taking Plavix, their daily asprin doese must not exceed 81 mg.
Participants msut agree to infor their study physician if changes in the need for anticoagulation therapy occur during their participation in SELECT.
Participants must not have a history of hemorrhagic stroke. Participants must have a systolic blood pressure of less than 160 mg/Hg and diastolic blood pressure of less than 90 mm/Hg at the randomization visit. NOTE: Paticipants may be receiving anti-hypertension medication at the time of randomization. These blood pressure criteria were chosen based on an elevated risk of hemorrhagic stroke among male smokers in the ATBC study with systolic blood pressure of equal to or greater than 160mm/Hg. Men with elevated blood pressure who have systolic less than 160mm/Hg AND who have diastolic blood pressure of less than 90mm/Hg have not shown to be at increased risk of hemorrhagic stroke. See section 7.1 for the management of participants with a systolic blood pressure of equal to or greater than 140mm/Hg or a diastolic blood pressure of equal to or greater than 90 mm/Hg.
Individuals who are participating in any other clinical trials involving a medical, surgical, nutritional or life-style intervention are ineligible ( unless they are no longer receiveing the intervention and are in the follow-up phase only). Participants must also gree not to loin sich a trial while participating in SELECT. Participants in the PLCO (Prostate , Lung, Colorectal and Ovarian screening trial) or the NLST (NAational Lung Screening Trial) sponsored by the Nastion Cancer institute are specifically not eligible to participate in SELECT. Those individuals who were randomized to the PCPT prior to March 22,1996 must have completed the PCPT end of study biopsy requirement during the end of study window (7 years plus or minus 90 days) and the end of study biopsy results must have been returned and must not be positive for prostate cancer or high grade (Grade 2-3) PIN. Men randomized to PCPT on March 22, 1996 or after are not required to have completed the PCPT end of study biopsy in order to to be eligible to SELECT.
Individuals with retinitis pigmentosa are not eligible.
All participants muct be informed of the ivestigational nature of this study and must sign and give written concent in accorfance with institiutional and federal guidlines.
At the tine of randomiztion, the Study Site name and ID number must be provided to the statistical center during the randomization program in order to ensure that the curent (within 363 days) date of institutional review board approval for this study has been entered into the database.