Table 4.

Analysis of PSA Progression in the Bicalutamide EPC Program

				Time Taken for First 10%
				of Patients to Progress (y)
Risk Group	No. Patients	HR (95% CI)	ETR (95% CI)	Bicalutamide 150 mg/d	Placebo
Overall population	4454	0.49 (0.43–0.56)	1.94 (1.71–2.21)	2.0	1.1
Disease stage
Localized disease	2734	0.59 (0.48–0.72)	1.65 (1.36–2.00)	2.6	1.7
Locally advanced disease	1719	0.42 (0.35–0.50)	2.22 (1.87–2.65)	1.5	0.7
Nodal status
N0	3970	0.50 (0.43–0.58)	1.90 (1.66–2.19)	2.1	1.2
Nx	410	0.57 (0.37–0.87)	1.65 (1.11–2.44)	1.9	1.1
N+	74	0.11 (0.04–0.30)	6.00 (2.64–13.60)	1.6	0.3
Gleason score
2–4	456	0.57 (0.34–0.96)	1.56 (1.02–2.38)	2.7	1.7
5–6	2020	0.50 (0.40–0.62)	1.94 (1.56–2.41)	2.5	1.4
7–10	1959	0.48 (0.40–0.58)	1.98 (1.66–2.35)	1.6	0.9
Pretherapy PSA
≤ 4 ng/mL	451	0.97 (0.57–1.65)	1.03 (0.60–1.76)	2.5	2.6
> 4–10 ng/mL	2229	0.53 (0.43–0.66)	1.79 (1.46–2.19)	2.4	1.4
> 10 ng/mL	1636	0.40 (0.33–0.49)	2.31 (1.92–2.79)	1.6	0.7
Postprostatectomy PSA
Nonquantifiable	3792	0.52 (0.45–0.61)	1.78 (1.54–2.05)	2.3	1.4
Quantifiable	587	0.38 (0.28–0.51)	2.75 (2.02–3.74)	2.0	0.4

HR, hazard ratio; ETR, event time ratio