Table 1.

Patient characteristics (eligible, randomized patients)

Selenium arm (N = 212)Placebo arm (N = 211)
Age,an (%)
 <50 y9 (4.3)7 (3.3)
 50–54 y20 (9.4)20 (9.5)
 55–60 y28 (13.2)35 (16.6)
 61–70 y96 (45.3)98 (46.5)
 >70 y59 (27.8)51 (24.2)
Race,an (%)
 White177 (83.5)162 (76.8)
 Black26 (12.3)26 (12.3)
 Nonblack Hispanic4 (1.9)13 (6.2)
 Other5 (2.4)6 (2.8)
 Unknown4 (1.9)
Performance status 0 (at randomization), n (%)201 (94.8)194 (91.9)
Vitamin E supplementation,an (%)56 (26.4)59 (28.0)
Baseline PSA,an (%)—reported by site
 <4 ng/mL81 (38.2)90 (42.6)
 4–10 ng/mL131 (61.8)121 (57.4)
 Total212 (100)211 (100)
Baseline biopsy requirement, n (%)
 2 Biopsies required (< December 15, 2002)70 (33.0)70 (33.2)
 2 Biopsies required (≥ December 15, 2002)27 (12.7)28 (13.3)
 1 Biopsy (≥ December 15, 2002)115 (54.3)113 (53.5)
Body mass index, n (%)
 < 2546 (21.7)55 (26.1)
 25–2864 (30.2)60 (28.4)
 29–3046 (21.7)38 (18.0)
 >3056 (26.4)58 (27.5)
Average cores biopsied (min–max); unknown %
 First biopsya, b10.5 (2–32); 12.710.7 (2–27); 10.9
 Second biopsy9.7 (4–18); 30.210.6 (4–25); 21.5
Average of HGPIN-positive cores (min–max); unknown %
 First biopsy1.6 (1–12); 0.51.5 (1–10); 1.0
 Second biopsy0.8 (0–6); 12.40.9 (0–8); 9.8
  • aStratification factors.

  • bStratification factor implemented in November 2002, after the trial had begun.