SELECT — Selenium and Vitamin E Cancer Prevention Trial (SELECT): Effect of Selenium and Vitamin E on Risk of Prostate Cancer and Other Cancers

Phase 3 · 2009 · Prostate Cancer

Design

Randomized, double-blind, placebo-controlled 2x2 factorial phase 3 chemoprevention trial of selenium, vitamin E, both, or placebo.

Population

Relatively healthy men 50 years or older (Black men) or 55 years or older (all others) with PSA of 4.0 ng/mL or lower and normal digital rectal examination.

Primary Endpoint

Incidence of prostate cancer

Key Result

Neither selenium nor vitamin E, alone or combined, reduced prostate cancer incidence; vitamin E was later associated with a statistically significant 17% increase in prostate cancer risk (HR 1.17, 99% CI 1.004-1.36; P=0.008).

Guideline Impact

Guidelines recommend against vitamin E or selenium supplementation for prostate cancer prevention