Table 3.

Study endpoints (by treatment assignment)

SeleniumPlacebo
Number randomized227225
Ineligible1514
Eligible212211
Endpoint status at 3 y, n (%)77 (36.3)77 (36.5)
EOS > 90 d out918
Died46
Non–prostate cancer primary cancer41
Intercurrent illness53
MD recommended no EOS biopsy65
Declined EOS biopsy2118
Lost to follow-up1312
Withdrew consent45
Other119
Endpoint known, n (%)135 (63.7)134 (63.5)
 Prostate cancer,an (%)48 (35.6)49 (36.6)a
  Interim2422
  EOS2427
 Negative EOS biopsy, n (%)87 (64.4)85 (63.4)

Abbreviation: EOS, end of study.

  • aP value comparing selenium versus placebo patients is 0.73 for 3-year biopsy-proven carcinoma, adjusted for the stratification factors age older than 60, African American, baseline PSA, and vitamin E supplementation.