Table 1. Baseline Demographic and Disease Characteristics.
| Parameter | No. (%) | ||
|---|---|---|---|
| Enzalutamide (n = 114) | AS (n = 113) | Total (N = 227) | |
| Age, mean (SD), y | 65.2 (8.2) | 66.9 (7.3) | 66.1 (7.8) |
| Median (range) | 65.0 (41-87) | 66.0 (52-87) | 65.0 (41-87) |
| Racea | |||
| Asian | 0 | 1 (0.9) | 1 (0.4) |
| Black or African American | 8 (7.0) | 13 (11.5) | 21 (9.3) |
| Hispanic | 1 (0.9) | 0 | 1 (0.4) |
| White | 105 (92.1) | 99 (87.6) | 204 (89.9) |
| BMI, mean (SD) | 29.7 (4.4) | 28.7 (4.4) | 29.2 (4.4) |
| Prostate cancer risk | |||
| Lowb | 61 (53.5) | 60 (53.1) | 121 (53.3) |
| Intermediatec | 53 (46.5) | 53 (46.9) | 106 (46.7) |
| Type of follow-up biopsy | |||
| mpMRI-targeted | 27 (23.7) | 28 (24.8) | 55 (24.2) |
| Non–mpMRI-targeted | 87 (76.3) | 85 (75.2) | 172 (75.8) |
| Time since prostate cancer diagnosis, mean (SD), y | 0.3 (0.51) | 0.2 (0.24) | 0.3 (0.40) |
| Median (range) | 0.2 (0-5) | 0.2 (0-2) | 0.2 (0-5) |
| Clinical tumor stage at prostate cancer diagnosis | |||
| T1-T1b | 0 | 1 (0.9) | 1 (0.4) |
| T1c-T2a | 107 (93.9) | 106 (93.8) | 213 (93.8) |
| T2b-T2c | 7 (6.1) | 6 (5.3) | 13 (5.7) |
| Clinical lymph nodes at prostate cancer diagnosis | |||
| NX | 50 (43.9) | 42 (37.2) | 92 (40.5) |
| N0 | 64 (56.1) | 71 (62.8) | 135 (59.5) |
| Distant metastases at prostate cancer diagnosis | |||
| MX | 53 (46.5) | 48 (42.5) | 101 (44.5) |
| M0 | 61 (53.5) | 65 (57.5) | 126 (55.5) |
| Total Gleason score at prostate cancer diagnosis | |||
| 6 | 67 (58.8) | 66 (58.4) | 133 (58.6) |
| 7 (3 + 4 pattern only) | 46 (40.4) | 47 (41.6) | 93 (41.0) |
| Unknown | 1 (0.9) | 0 | 1 (0.4) |
| LS cancer-positive cores, mean (SE), %d | 25.43 (1.61) | 23.12 (1.58) | NA |
| Serum PSA levels, median (range), ng/mL | 5.8 (1-17) | 5.9 (1-23) | 5.9 (1-23) |
Abbreviations: AS, active surveillance; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); LS, least squares; mpMRI, multiparametric magnetic resonance imaging; NA, not available; PSA, prostate-specific antigen.
SI conversion factor: To convert PSA to μg/L, multiply by 1.
Self-reported.
Low-risk prostate cancer was defined per National Comprehensive Cancer Network guidelines as T1c-T2a, PSA levels of less than 10 ng/mL, N0, M0, and Gleason score of 6 or lower.
Intermediate-risk prostate cancer was defined per National Comprehensive Cancer Network guidelines as T2b-T2c, PSA level of less than 20 ng/mL, N0, M0, and Gleason score of 7 or lower (3 + 4 pattern only).
Based on the most recent biopsy taken during the 6 months before screening.