Table 1.

Complete list of individual variables

Case no.Age (a)PSA at the time of enrollment (b)Prostate volume at the time of enrollment, mL (c)Prostate volume at the end of the study, mL (d)No. of HG-PIN cores/total cores taken at the time of enrollment (e)No. of total cores taken at the end of the study (f)
(A) Placebo arm
1567.0045504 of 810
2718.2090901 of 810
3618.0038322 of 810
4561.1525281 of 810
5787.0035351 of 1012
6614.2243404 of 812
77419.1952502 of 1012
85921.7075752 of 1010
9685.6060653 of 88
10707.1270736 of 1010
11614.3336361 of 1210
12685.6135381 of 1212
13733.3045452 of 1412
14604.9285851 of 1212
15742.8228301 of 1012
16585.4035321 of 88
17715.2538386 of 1012
18559.9070701 of 810
19706.7770701 of 1212
20595.3222221 of 1010
21648.5380801 of 812
22635.8060603 of 1212
237415.2233334 of 1010
24722.6425231 of 1010
25689.401001003 of 1214
266835.7035351 of 1012
27576.1160601 of 1012
28684.7645451 of 1010
29562.0725261 of 1012
30606.0738351 of 812
Mean ± SD65.1 ± 6.87.9 ± 6.949.9 ± 21.550.0 ± 21.8N/AN/A
Total cores296330
No. of monofocal HG-PIN18
No. of plurifocal HG-PIN12
(B) GTC arm
316215.6156501 of 1012
32575.5045481 of 1010
33548.3355481 of 1212
34618.0052581 of 812
35635.1368702 of 1012
36757.9343453 of 1012
37484.5038351 of 1010
38687.4055601 of 810
39655.5035302 of 1212
40634.2235332 of 1212
417017.0042451 of 1010
42709.8826256 of 1012
43706.4032314 of 1012
44646.4135371 of 1012
456910.4390955 of 1014
46656.7838422 of 810
47604.6527251 of 810
48616.0242446 of 1212
49693.3050482 of 1012
50616.2682752 of 1414
51585.3640381 of 810
52647.0085872 of 1012
53657.601101001 of 814
547213.6046441 of 1012
55672.3730302 of 1212
566512.0045401 of 1010
576515.8550551 of 1412
58663.4038421 of 810
59756.4245381 of 1012
60606.3035331 of 1010
Mean ± SD64.4 ± 5.97.6 ± 3.849.0 ± 19.848.3 ± 19.5N/AN/A
Total cores304346
No. of monofocal HG-PIN17
No. of plurifocal HG-PIN13
(C) Summary and statistical analysis
Placebo arm
    Mean ± SD65.1 ± 6.87.9 ± 6.949.9 ± 21.550.0 ± 21.8
    P values (95% confidence, end vs. enrollment)0.813
GTC arm
    Mean ± SD64.4 ± 5.97.6 ± 3.849.0 ± 19.848.3 ± 19.5
P values (95% confidence, end vs. enrollment)0.427
    P values (95% confidence, placebo vs. GTC)0.6700.8190.8620.756
  • NOTE: (a) Age of subject at the time of diagnosis, (b) total serum PSA at the time of enrollment, (c) prostate volume at the time of enrollment, (d) prostate volume at the end of study, (e) total number of HG-PIN cores / total number of HG-PIN cores versus total cores taken at the time of enrollment, (f) total number of HG-PIN cores taken at the end of study of volunteers of placebo arm (A) and GTC arm (B). At the end of the study, only 1 of 24 patients in the placebo arm and 2 of 29 patients of the GTC arm were diagnosed for HG-PIN. The summary of such data (mean values ± SD) are also provided (C). Statistical analysis (t test analysis) shows that none of the variables considered were significantly different in the two arms of the study with 95% confidence (age, P = 0.670; PSA, P = 0.819; prostate volume at the enrollment, P = 0.862; prostate volume at the end of study, P = 0.756). Also prostate volumes at the enrollment were not significantly different from those at the end of the study in placebo arm (P = 0.813) or GTC arm (P = 0.427).