Table 1.

Selected characteristics of participants in the HGPIN tomato extract trial, by treatment assignment

	Lycopene n	Placebo n	P Value
Pre- and post-treatment biopsy	26	32	-
Pre- and post-treatment blood obtained	25	31	-
Race
White	19	23	0.55
African-American	6	9
Other	1	0
Family history of PCa (1^st degree)	1	1	-
Suspicious DRE (before baseline biopsy)	4	5	0.98

	mean (sd)	mean (sd)

Age, baseline, years	62.9 (8.3)	67.1 (8.1)	0.06
Clinical PSA before enrollment, ng/ml	4.89 (2.51)	4.72 (2.66)	0.81
Research PSA at baseline, ng/ml	5.50 (3.73)	6.18 (4.57)	0.55
Time on treatment, days	175.6 (31.8)	200.2 (70.2)	0.10
Pre-treatment gland volume, cc⁺	45.3 (20.3)	53.9 (30.4)	0.26
Post-treatment gland volume	46.7 (20.6)	51.9 (29.5)	0.54
Serum lycopene, baseline, μmol/L	0.94 (0.50)	0.95 (0.50)	0.96
Lycopene intake, baseline, mg/day	3.98 (3.29)	3.42 (3.36)	0.54
Tomato food intake, baseline, servings/week	7.95 (7.23)	6.44 (4.62)	0.34
Pro-vitamin A intake, baseline, mg/day	4.36 (3.44)	5.81 (10.0)	0.49
Total dietary fat intake, baseline, g/day	67.6 (59.4)	60.9 (33.8)	0.61
Capsules consumed^*	n (%)	n (%)
> 75%	24 (92)	28 (88)	0.68
50-75%	2 (8)	4 (12)
< 50%	0	0

⁺

By TRUS, unless unavailable, then by DRE

By pill count, unless unavailable, then by self-report.