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 . | . | . | . | . | . | . | ||||||
1 | 56 | 7.00 | 45 | 50 | 4 of 8 | 10 | ||||||
2 | 71 | 8.20 | 90 | 90 | 1 of 8 | 10 | ||||||
3 | 61 | 8.00 | 38 | 32 | 2 of 8 | 10 | ||||||
4 | 56 | 1.15 | 25 | 28 | 1 of 8 | 10 | ||||||
5 | 78 | 7.00 | 35 | 35 | 1 of 10 | 12 | ||||||
6 | 61 | 4.22 | 43 | 40 | 4 of 8 | 12 | ||||||
7 | 74 | 19.19 | 52 | 50 | 2 of 10 | 12 | ||||||
8 | 59 | 21.70 | 75 | 75 | 2 of 10 | 10 | ||||||
9 | 68 | 5.60 | 60 | 65 | 3 of 8 | 8 | ||||||
10 | 70 | 7.12 | 70 | 73 | 6 of 10 | 10 | ||||||
11 | 61 | 4.33 | 36 | 36 | 1 of 12 | 10 | ||||||
12 | 68 | 5.61 | 35 | 38 | 1 of 12 | 12 | ||||||
13 | 73 | 3.30 | 45 | 45 | 2 of 14 | 12 | ||||||
14 | 60 | 4.92 | 85 | 85 | 1 of 12 | 12 | ||||||
15 | 74 | 2.82 | 28 | 30 | 1 of 10 | 12 | ||||||
16 | 58 | 5.40 | 35 | 32 | 1 of 8 | 8 | ||||||
17 | 71 | 5.25 | 38 | 38 | 6 of 10 | 12 | ||||||
18 | 55 | 9.90 | 70 | 70 | 1 of 8 | 10 | ||||||
19 | 70 | 6.77 | 70 | 70 | 1 of 12 | 12 | ||||||
20 | 59 | 5.32 | 22 | 22 | 1 of 10 | 10 | ||||||
21 | 64 | 8.53 | 80 | 80 | 1 of 8 | 12 | ||||||
22 | 63 | 5.80 | 60 | 60 | 3 of 12 | 12 | ||||||
23 | 74 | 15.22 | 33 | 33 | 4 of 10 | 10 | ||||||
24 | 72 | 2.64 | 25 | 23 | 1 of 10 | 10 | ||||||
25 | 68 | 9.40 | 100 | 100 | 3 of 12 | 14 | ||||||
26 | 68 | 35.70 | 35 | 35 | 1 of 10 | 12 | ||||||
27 | 57 | 6.11 | 60 | 60 | 1 of 10 | 12 | ||||||
28 | 68 | 4.76 | 45 | 45 | 1 of 10 | 10 | ||||||
29 | 56 | 2.07 | 25 | 26 | 1 of 10 | 12 | ||||||
30 | 60 | 6.07 | 38 | 35 | 1 of 8 | 12 | ||||||
Mean ± SD | 65.1 ± 6.8 | 7.9 ± 6.9 | 49.9 ± 21.5 | 50.0 ± 21.8 | N/A | N/A | ||||||
Total cores | 296 | 330 | ||||||||||
No. of monofocal HG-PIN | 18 | |||||||||||
No. of plurifocal HG-PIN | 12 | |||||||||||
(B) GTC arm | ||||||||||||
31 | 62 | 15.61 | 56 | 50 | 1 of 10 | 12 | ||||||
32 | 57 | 5.50 | 45 | 48 | 1 of 10 | 10 | ||||||
33 | 54 | 8.33 | 55 | 48 | 1 of 12 | 12 | ||||||
34 | 61 | 8.00 | 52 | 58 | 1 of 8 | 12 | ||||||
35 | 63 | 5.13 | 68 | 70 | 2 of 10 | 12 | ||||||
36 | 75 | 7.93 | 43 | 45 | 3 of 10 | 12 | ||||||
37 | 48 | 4.50 | 38 | 35 | 1 of 10 | 10 | ||||||
38 | 68 | 7.40 | 55 | 60 | 1 of 8 | 10 | ||||||
39 | 65 | 5.50 | 35 | 30 | 2 of 12 | 12 | ||||||
40 | 63 | 4.22 | 35 | 33 | 2 of 12 | 12 | ||||||
41 | 70 | 17.00 | 42 | 45 | 1 of 10 | 10 | ||||||
42 | 70 | 9.88 | 26 | 25 | 6 of 10 | 12 | ||||||
43 | 70 | 6.40 | 32 | 31 | 4 of 10 | 12 | ||||||
44 | 64 | 6.41 | 35 | 37 | 1 of 10 | 12 | ||||||
45 | 69 | 10.43 | 90 | 95 | 5 of 10 | 14 | ||||||
46 | 65 | 6.78 | 38 | 42 | 2 of 8 | 10 | ||||||
47 | 60 | 4.65 | 27 | 25 | 1 of 8 | 10 | ||||||
48 | 61 | 6.02 | 42 | 44 | 6 of 12 | 12 | ||||||
49 | 69 | 3.30 | 50 | 48 | 2 of 10 | 12 | ||||||
50 | 61 | 6.26 | 82 | 75 | 2 of 14 | 14 | ||||||
51 | 58 | 5.36 | 40 | 38 | 1 of 8 | 10 | ||||||
52 | 64 | 7.00 | 85 | 87 | 2 of 10 | 12 | ||||||
53 | 65 | 7.60 | 110 | 100 | 1 of 8 | 14 | ||||||
54 | 72 | 13.60 | 46 | 44 | 1 of 10 | 12 | ||||||
55 | 67 | 2.37 | 30 | 30 | 2 of 12 | 12 | ||||||
56 | 65 | 12.00 | 45 | 40 | 1 of 10 | 10 | ||||||
57 | 65 | 15.85 | 50 | 55 | 1 of 14 | 12 | ||||||
58 | 66 | 3.40 | 38 | 42 | 1 of 8 | 10 | ||||||
59 | 75 | 6.42 | 45 | 38 | 1 of 10 | 12 | ||||||
60 | 60 | 6.30 | 35 | 33 | 1 of 10 | 10 | ||||||
Mean ± SD | 64.4 ± 5.9 | 7.6 ± 3.8 | 49.0 ± 19.8 | 48.3 ± 19.5 | N/A | N/A | ||||||
Total cores | 304 | 346 | ||||||||||
No. of monofocal HG-PIN | 17 | |||||||||||
No. of plurifocal HG-PIN | 13 | |||||||||||
(C) Summary and statistical analysis | ||||||||||||
Placebo arm | ||||||||||||
Mean ± SD | 65.1 ± 6.8 | 7.9 ± 6.9 | 49.9 ± 21.5 | 50.0 ± 21.8 | ||||||||
P values (95% confidence, end vs. enrollment) | 0.813 | |||||||||||
GTC arm | ||||||||||||
Mean ± SD | 64.4 ± 5.9 | 7.6 ± 3.8 | 49.0 ± 19.8 | 48.3 ± 19.5 | ||||||||
P values (95% confidence, end vs. enrollment) | 0.427 | |||||||||||
P values (95% confidence, placebo vs. GTC) | 0.670 | 0.819 | 0.862 | 0.756 |
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 . | . | . | . | . | . | . | ||||||
1 | 56 | 7.00 | 45 | 50 | 4 of 8 | 10 | ||||||
2 | 71 | 8.20 | 90 | 90 | 1 of 8 | 10 | ||||||
3 | 61 | 8.00 | 38 | 32 | 2 of 8 | 10 | ||||||
4 | 56 | 1.15 | 25 | 28 | 1 of 8 | 10 | ||||||
5 | 78 | 7.00 | 35 | 35 | 1 of 10 | 12 | ||||||
6 | 61 | 4.22 | 43 | 40 | 4 of 8 | 12 | ||||||
7 | 74 | 19.19 | 52 | 50 | 2 of 10 | 12 | ||||||
8 | 59 | 21.70 | 75 | 75 | 2 of 10 | 10 | ||||||
9 | 68 | 5.60 | 60 | 65 | 3 of 8 | 8 | ||||||
10 | 70 | 7.12 | 70 | 73 | 6 of 10 | 10 | ||||||
11 | 61 | 4.33 | 36 | 36 | 1 of 12 | 10 | ||||||
12 | 68 | 5.61 | 35 | 38 | 1 of 12 | 12 | ||||||
13 | 73 | 3.30 | 45 | 45 | 2 of 14 | 12 | ||||||
14 | 60 | 4.92 | 85 | 85 | 1 of 12 | 12 | ||||||
15 | 74 | 2.82 | 28 | 30 | 1 of 10 | 12 | ||||||
16 | 58 | 5.40 | 35 | 32 | 1 of 8 | 8 | ||||||
17 | 71 | 5.25 | 38 | 38 | 6 of 10 | 12 | ||||||
18 | 55 | 9.90 | 70 | 70 | 1 of 8 | 10 | ||||||
19 | 70 | 6.77 | 70 | 70 | 1 of 12 | 12 | ||||||
20 | 59 | 5.32 | 22 | 22 | 1 of 10 | 10 | ||||||
21 | 64 | 8.53 | 80 | 80 | 1 of 8 | 12 | ||||||
22 | 63 | 5.80 | 60 | 60 | 3 of 12 | 12 | ||||||
23 | 74 | 15.22 | 33 | 33 | 4 of 10 | 10 | ||||||
24 | 72 | 2.64 | 25 | 23 | 1 of 10 | 10 | ||||||
25 | 68 | 9.40 | 100 | 100 | 3 of 12 | 14 | ||||||
26 | 68 | 35.70 | 35 | 35 | 1 of 10 | 12 | ||||||
27 | 57 | 6.11 | 60 | 60 | 1 of 10 | 12 | ||||||
28 | 68 | 4.76 | 45 | 45 | 1 of 10 | 10 | ||||||
29 | 56 | 2.07 | 25 | 26 | 1 of 10 | 12 | ||||||
30 | 60 | 6.07 | 38 | 35 | 1 of 8 | 12 | ||||||
Mean ± SD | 65.1 ± 6.8 | 7.9 ± 6.9 | 49.9 ± 21.5 | 50.0 ± 21.8 | N/A | N/A | ||||||
Total cores | 296 | 330 | ||||||||||
No. of monofocal HG-PIN | 18 | |||||||||||
No. of plurifocal HG-PIN | 12 | |||||||||||
(B) GTC arm | ||||||||||||
31 | 62 | 15.61 | 56 | 50 | 1 of 10 | 12 | ||||||
32 | 57 | 5.50 | 45 | 48 | 1 of 10 | 10 | ||||||
33 | 54 | 8.33 | 55 | 48 | 1 of 12 | 12 | ||||||
34 | 61 | 8.00 | 52 | 58 | 1 of 8 | 12 | ||||||
35 | 63 | 5.13 | 68 | 70 | 2 of 10 | 12 | ||||||
36 | 75 | 7.93 | 43 | 45 | 3 of 10 | 12 | ||||||
37 | 48 | 4.50 | 38 | 35 | 1 of 10 | 10 | ||||||
38 | 68 | 7.40 | 55 | 60 | 1 of 8 | 10 | ||||||
39 | 65 | 5.50 | 35 | 30 | 2 of 12 | 12 | ||||||
40 | 63 | 4.22 | 35 | 33 | 2 of 12 | 12 | ||||||
41 | 70 | 17.00 | 42 | 45 | 1 of 10 | 10 | ||||||
42 | 70 | 9.88 | 26 | 25 | 6 of 10 | 12 | ||||||
43 | 70 | 6.40 | 32 | 31 | 4 of 10 | 12 | ||||||
44 | 64 | 6.41 | 35 | 37 | 1 of 10 | 12 | ||||||
45 | 69 | 10.43 | 90 | 95 | 5 of 10 | 14 | ||||||
46 | 65 | 6.78 | 38 | 42 | 2 of 8 | 10 | ||||||
47 | 60 | 4.65 | 27 | 25 | 1 of 8 | 10 | ||||||
48 | 61 | 6.02 | 42 | 44 | 6 of 12 | 12 | ||||||
49 | 69 | 3.30 | 50 | 48 | 2 of 10 | 12 | ||||||
50 | 61 | 6.26 | 82 | 75 | 2 of 14 | 14 | ||||||
51 | 58 | 5.36 | 40 | 38 | 1 of 8 | 10 | ||||||
52 | 64 | 7.00 | 85 | 87 | 2 of 10 | 12 | ||||||
53 | 65 | 7.60 | 110 | 100 | 1 of 8 | 14 | ||||||
54 | 72 | 13.60 | 46 | 44 | 1 of 10 | 12 | ||||||
55 | 67 | 2.37 | 30 | 30 | 2 of 12 | 12 | ||||||
56 | 65 | 12.00 | 45 | 40 | 1 of 10 | 10 | ||||||
57 | 65 | 15.85 | 50 | 55 | 1 of 14 | 12 | ||||||
58 | 66 | 3.40 | 38 | 42 | 1 of 8 | 10 | ||||||
59 | 75 | 6.42 | 45 | 38 | 1 of 10 | 12 | ||||||
60 | 60 | 6.30 | 35 | 33 | 1 of 10 | 10 | ||||||
Mean ± SD | 64.4 ± 5.9 | 7.6 ± 3.8 | 49.0 ± 19.8 | 48.3 ± 19.5 | N/A | N/A | ||||||
Total cores | 304 | 346 | ||||||||||
No. of monofocal HG-PIN | 17 | |||||||||||
No. of plurifocal HG-PIN | 13 | |||||||||||
(C) Summary and statistical analysis | ||||||||||||
Placebo arm | ||||||||||||
Mean ± SD | 65.1 ± 6.8 | 7.9 ± 6.9 | 49.9 ± 21.5 | 50.0 ± 21.8 | ||||||||
P values (95% confidence, end vs. enrollment) | 0.813 | |||||||||||
GTC arm | ||||||||||||
Mean ± SD | 64.4 ± 5.9 | 7.6 ± 3.8 | 49.0 ± 19.8 | 48.3 ± 19.5 | ||||||||
P values (95% confidence, end vs. enrollment) | 0.427 | |||||||||||
P values (95% confidence, placebo vs. GTC) | 0.670 | 0.819 | 0.862 | 0.756 |
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).