Table 1.

Demographic characteristics of all study participants randomized to the clinical trial (N = 97)

Poly E (N = 49)Placebo (N = 48)
VariablesLevelsN (%)N (%)Pa
Age, yMean (SD)62.0 (7.9)64.1 (7.9)0.24
RaceBlack or African American8 (16.3)12 (25.0)
White41 (83.7)36 (75.0)0.32
EthnicityHispanic6 (12.2)3 (6.3)
Non-Hispanic42 (85.7)45 (93.8)
Unknown1 (2.0)0 (0.0)0.40
Family history of prostate cancerN42 (85.7)45 (93.8)
Y7 (14.3)3 (6.3)0.32
Body mass index (weight in Kgs/height in m2)Mean (SD)29.6 (4.9)29.8 (4.9)0.91
PSA (ng/mL)Mean (SD)4.5 (1.8)4.6 (2.1)0.67
Subjects with baseline HGPIN32 (65.3)34 (70.8)0.66
No. of cores with baseline HGPINMean (SD)1.8 (1.4)2 (1.1)0.13
Subjects with baseline ASAP17 (34.7)14 (29.2)0.66
No. of cores with baseline ASAPMean (SD)1.3 (0.6)1.5 (0.8)0.44
  • aP values were computed by Fisher exact test for categorical variables, Wilcoxon rank-sum test for continuous variables.