Table 3.

Histopathologic, serologic, and physiologic outcomes

Controls (n = 41)FS (n = 40)LF (n = 40)FS + LF (n = 40)P*
Tumor proliferation rate (Ki-67), median (95% CI)
3.23 (2.42-3.92)1.66 (1.13-2.64)2.56 (2.00-3.69)1.50 (1.05-2.65)FS = 0.0013/LF = 0.661
Tumor apoptotic rate (TdT-mediated dUTP nick end labeling), % (n)
    084 (33)74 (29)74 (26)89 (32)FS = 0.880/LF = 0.730
    >0 to 113 (5)16 (6)14 (5)3 (1)
    >1 to 23 (1)10 (4)12 (4)8 (3)
Gleason sum, median (95% CI)
    Biopsy6 (6-7)6 (6-6)6 (6-6)6 (6-7)FS = 0.538/LF = 0.918
    Surgical7 (6-7)6 (6-7)6 (6-7)7 (6-7)
PSA (ng/mL), median (95% CI)
    Baseline5.3 (3.7-5.8)6.2 (4.8-7.7)5.5 (4.6-6.7)5.9 (4.9-9.4)FS = 0.286/LF = 0.764
    Follow-up4.9 (3.5-6.2)6.4 (5.0-7.0)5.6 (3.9-6.7)5.7 (4.9-8.6)
Testosterone (ng/dL), median (95% CI)
    Baseline442 (386-458)424 (358-475)423 (387-476)414 (346-446)FS = 0.120/LF = 0.394
    Follow-up372 (334-429)387 (351-430)377 (327-399)382 (346-448)
SHBG (nmol/L), median (95% CI)
    Baseline31 (27-39)34 (25-41)33 (28-37)31 (28-35)FS = 0.597/LF = 0.066
    Follow-up28 (22-37)31 (28-37)31 (26-35)32 (26-35)
Free androgen index, median (95% CI)
    Baseline13.3 (10.9-14.3)12.6 (11.5-14.2)13.2 (11.8-14.3)12.8 (11.9-14.7)FS = 0.148/LF = 0.123
    Follow-up12.1 (11.0-13.0)12.0 (10.9-15.0)11.3 (10.2-13.0)11.8 (10.6-13.2)
IGF-I (ng/mL), median (95% CI)
    Baseline120 (106-133)124 (115-148)133 (109-150)129 (110-148)FS = 0.174/LF = 0.370
    Follow-up112 (98-128)119 (107-133)123 (100-141)125 (113-139)
IGFBP-3 (mg/L), median (95% CI)
    Baseline4.2 (3.6-4.5)4.1 (3.9-4.5)4.2 (4.0-4.5)4.1 (3.9-4.9)FS = 0.859/LF = 0.853
    Follow-up3.7 (3.3-4.5)4.0 (3.5-4.3)3.8 (3.3-4.3)3.8 (3.6-4.3)
C-reactive protein (mg/L), median (95% CI)
    Baseline1.5 (1.1-2.2)1.4 (1.0-2.7)1.6 (1.2-2.5)1.2 (0.9-2.5)FS = 0.668/LF = 0.982
    Follow-up1.6 (1.1-2.4)1.8 (1.3-2.3)2.0 (1.1-3.2)1.1 (0.8-2.1)
Total cholesterol (mg/dL), median (95% CI)
    Baseline230 (212-252)217 (205-245)222 (206-240)218 (210-228)FS = 0.174/LF = 0.048
    Follow-up196 (180-226)211 (118-220)182 (161-192)183 (168-206)
Low-density cholesterol (mg/dL), median (95% CI)
    Baseline130 (113-144)124 (110-138)134 (122-146)123 (115-141)FS = 0.621/LF = 0.032
    Follow-up111 (90-128)111 (89-121)105 (90-124)107 (93-121)
Body mass index (kg/m2), median (95% CI)
    Baseline28.9 (27.4-30.0)28.0 (26.8-29.8)29.0 (27.0-31.0)27.1 (25.8-30.4)FS = 0.496/LF = 0.003
    Follow-up29.1 (27.2-30.0)27.6 (26.8-29.7)28.0 (26.5-29.5)26.9 (25.3-29.5)
  • * For factors that have both baseline and follow-up data, factorial testing was done under intent-to-treat analysis on change scores and P values are reported for both FS and LF conditions.

  • Intraassay and interassay coefficients of variation, with accompanying mean (SD) are as follows: PSA 1.2%, 4.39 (0.05) ng/mL and 3.7%, 4.61 (0.17) ng/mL; testosterone 4.4%, 365.4 (12.7) ng/dL and 6.6%, 365.4 (18.1) ng/dL; SHBG 2.5%, 21 (0.52) nmol/L and 5.2%, 21 (1.1) nmol/L; IGF-I 3.8%, 169 (6.9) ng/mL and 5.4%, 169 (9.1) ng/mL; IGFBP-3 4.2%, 3.59 (0.15) mg/L and 7.2%, 3.59 (0.26) mg/mL; C-reactive protein 1.8%, 6.2 (0.07) mg/L and 2.9%, 6.2 (0.1) mg/L; total cholesterol 0.8%, 231 (5.98) mg/dL and 210.1 (5.44) mg/dL; and low-density cholesterol 1.1%, 166 (3.9) mg/dL and 1.8%, 166 (4.3) mg/dL.

  • Free androgen index derived using the formula: total testosterone/SHBG.