S0000 Selenium and Vitamin E in Preventing Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Selenium and Vitamin E Cancer Prevention Trial (SELECT) for Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Vitamin E
* Drug: Selenium
* Other: Vitamin E placebo
* Other: selenium placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin E + selenium placebo<br>vitamin E and selenium placebo daily for 7-12 years | Drug: Vitamin E<br>* 400 IU daily by mouth for 7-12 years<br>* Other names: alpha tocopherol;Other: selenium placebo<br>* daily for 7-12 years<br>* Other names: placebo;|
| Experimental: Selenium + vitamin E placebo<br>selenium and vitamin E placebo daily for 7-12 years | Drug: Selenium<br>* 200 mcg daily for 7-12 years<br>* Other names: L-selenomethionine;Other: Vitamin E placebo<br>* daily for 7-12 years<br>* Other names: placebo;|
| Experimental: Vitamin E + selenium<br>vitamin E and selenium placebo daily for 7-12 years | Drug: Vitamin E<br>* 400 IU daily by mouth for 7-12 years<br>* Other names: alpha tocopherol;Drug: Selenium<br>* 200 mcg daily for 7-12 years<br>* Other names: L-selenomethionine;|
| Placebo Comparator: Vitamin E placebo + selenium placebo<br>vitamine E placebo and selenium placebo daily for 7-12 years | Other: Vitamin E placebo<br>* daily for 7-12 years<br>* Other names: placebo;Other: selenium placebo<br>* daily for 7-12 years<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Prostate Cancer | 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. | Every six months for 7 to 12 years depending on when the participant was randomized. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Lung Cancer | 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. | 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. | 
| Number of Participants With Colorectal Cancer | 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. | 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. | 
| Number of Participants With Any Diagnosis of Cancer | 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. | 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. | 
| Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival | 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. | 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. | 
| Number of Participants With Serious Cardiovascular Events | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer