Table 1.
Baseline Characteristics of Evaluable Study Participants
| Characteristics |
Intervention (n=81) |
Placebo (n=78) |
P Value for Difference |
|---|---|---|---|
| Age at randomization, mean (SD), y | 61.3 (7.2) | 60.7 (6.6) | .56a |
| Race/ethnicity, No. (%) | |||
| White | 71 (88) | 70 (90) | .82b,c |
| African American | 6 (7) | 5 (7) | .91b,d |
| Hispanic | 1 (1) | 1 (1) | |
| Asian | 1 (1) | 1 (1) | |
| Other (including Pacific Islander) | 2 (3) | 1 (1) | |
| Weight, mean (SD), kg | 87.1 (13.4) | 88.9 (14.8) | .36a |
| Height, mean (SD), cm | 177.4 (7.1) | 178.6 (8.4) | .31a |
| BMIe | |||
| Mean (SD) | 27.6 (3.6) | 27.9 (4.2) | .64a |
| Median (IQR) | 27.4 (3.90) | 27.4 (5.58) | .91b |
| Serum total cholesterol level, mean (SD), mg/dLf | 183.4 (29.8) | 187.4 (36.9) | .48a |
| High-risk characteristics | |||
| Preoperative PSA level, ng/mL | |||
| Mean (SD) | 7.13 (3.87) | 7.71 (4.20) | .36a |
| Median (IQR) | 5.90 (3.20) | 6.62 (3.98) | .21g |
| Gleason score, mean (SD) | 7.00 (0.82) | 7.01 (0.80) | .98g |
| 5 | 1 (1) | 0 | .78b,h |
| 6 | 19 (23) | 18 (23) | |
| 7 | 45 (56) | 47 (60) | |
| 8 | 11 (14) | 7 (9) | |
| 9 | 5 (6) | 6 (8) | |
| Positive surgical margins, No. (%) | 38 (47) | 27 (35) | .15i |
| Extracapsular extension, No. (%) | 54 (67) | 61 (78) | .11i |
| Positive seminal vesicle(s), No. (%) | 15 (19) | 12 (15) | .68i |
| Lymph node metastases, No./examined | 0/36 | 2/31 | .50i |
| High-risk characteristics, mean (SD), No. | 1.54 (0.78) | 1.50 (0.75) | .72a |
| 1 | 48 (59) | 8 (62) | .87bj |
| ≥2 | 33 (41) | 30 (38) |
Abbreviations: BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; IQR, interquartile range; PSA, prostate-specific antigen.
SI conversion: To convert total cholesterol to mmol/L, multiply by 0.0259.
a
By t test.
b
By χ2 test.
c
White vs all others.
d
White vs African American vs all others.
e
Calculated in 81 intervention participants and 77 placebo participants.
f
Calculated in 74 intervention participants and 76 placebo participants.
g
By Mann-Whitney test.
h
Score of 5 or 6 vs 7 vs 8 vs 9.
i
By Fisher exact test.
j
None vs 1 vs 2.