S0000 Selenium and Vitamin E in Preventing Prostate Cancer (SELECT)

SWOG Cancer Research Network

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Other: Vitamin E placebo; Drug: Selenium; Other: selenium placebo; Drug: Vitamin E

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006392

S0000 (Other Identifier)

U10CA037429 (U.S. NIH Grant/Contract)

CDR0000068277

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35,533 patients

Sex: Male

Ages: 50 to 120 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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35,533 participants in 4 patient groups, including a placebo group

Vitamin E + selenium placebo

Experimental group

Description:

vitamin E and selenium placebo daily for 7-12 years

Treatment:

Drug: Vitamin E

Other: selenium placebo

Selenium + vitamin E placebo

Experimental group

Description:

selenium and vitamin E placebo daily for 7-12 years

Treatment:

Drug: Selenium

Other: Vitamin E placebo

Vitamin E + selenium

Experimental group

Description:

vitamin E and selenium placebo daily for 7-12 years

Treatment:

Drug: Vitamin E

Drug: Selenium

Vitamin E placebo + selenium placebo

Placebo Comparator group

Description:

vitamine E placebo and selenium placebo daily for 7-12 years

Treatment:

Other: selenium placebo

Other: Vitamin E placebo