|
Characteristic
|
Study phase
|
|---|
|
Control
|
Transition
|
Intervention
|
Total:
| |
|---|
|
n (%)
|
n (%)
|
n (%)
|
N (%)
|
p value^
|
|---|
|
All patients:
|
505 (100%)
|
159 (100%)
|
407 (100%)
|
1071 (100%)
| |
|
Age
|
|
Median (years)
|
65.0
|
65.0
|
65.0
|
65.0
| |
|
Quartiles (years)
|
59–68
|
58–69
|
61–69
|
60–69
| |
|
Age group
|
|
40–59
|
128 (25%)
|
43 (27%)
|
81 (20%)
|
252 (24%)
|
0.145
|
|
60–69
|
284 (56%)
|
84 (53%)
|
231 (57%)
|
599 (56%)
| |
|
70+
|
93 (18%)
|
32 (20%)
|
95 (23%)
|
220 (21%)
| |
|
Extracapsular extension
|
|
No
|
96 (19%)
|
27 (17%)
|
69 (17%)
|
192 (18%)
|
0.511
|
|
Yes
|
406 (80%)
|
131 (82%)
|
338 (83%)
|
875 (82%)
| |
|
Unsure
|
3 (1%)
|
1 (1%)
|
0 (0%)
|
4 (0%)
| |
|
Positive surgical margin
|
|
No
|
229 (45%)
|
69 (43%)
|
198 (49%)
|
496 (46%)
|
0.087
|
|
Yes
|
276 (55%)
|
89 (56%)
|
204 (50%)
|
569 (53%)
| |
|
Unsure
|
0 (0%)
|
1 (1%)
|
5 (1%)
|
6 (1%)
| |
|
Seminal vesicle invasion
|
|
No
|
395 (78%)
|
131 (82%)
|
339 (83%)
|
865 (81%)
|
0.231
|
|
Yes
|
109 (22%)
|
28 (18%)
|
66 (16%)
|
203 (19%)
| |
|
Unsure
|
1 (0%)
|
0 (0%)
|
2 (0%)
|
3 (0%)
| |
|
Regional lymph node involvement
|
|
No
|
305 (60%)
|
98 (62%)
|
278 (68%)
|
681 (64%)
|
0.035
|
|
Yes
|
30 (6%)
|
5 (3%)
|
25 (6%)
|
60 (6%)
| |
|
Unsure
|
170 (34%)
|
56 (35%)
|
104 (26%)
|
330 (31%)
| |
|
Post-operative Gleason grade
|
|
6–7
|
395 (78%)
|
133 (84%)
|
344 (85%)
|
872 (81%)
|
0.132
|
|
8
|
30 (6%)
|
3 (2%)
|
18 (4%)
|
51 (5%)
| |
|
9–10
|
77 (15%)
|
22 (14%)
|
42 (10%)
|
141 (13%)
| |
|
Unsure
|
3 (1%)
|
1 (1%)
|
3 (1%)
|
7 (1%)
| |
|
Number of co-morbidities
|
|
0
|
103 (20%)
|
19 (12%)
|
70 (17%)
|
192 (18%)
|
0.050
|
|
1
|
72 (14%)
|
19 (12%)
|
45 (11%)
|
136 (13%)
| |
|
2
|
74 (15%)
|
23 (14%)
|
49 (12%)
|
146 (14%)
| |
|
3+
|
256 (51%)
|
98 (62%)
|
243 (60%)
|
597 (56%)
| |
|
Maximum PSA level within 4 months after RP (ng/ml)
|
|
< 0.1
|
399 (79%)
|
137 (86%)
|
339 (83%)
|
875 (82%)
|
0.224
|
|
≥ 0.1
|
83 (16%)
|
16 (10%)
|
51 (13%)
|
150 (14%)
| |
|
No PSA test recorded
|
23 (5%)
|
6 (4%)
|
17 (4%)
|
46 (4%)
| |
|
Site
|
|
Site 1
|
27 (5%)
|
14 (9%)
|
48 (12%)
|
89 (8%)
|
< 0.001
|
|
Site 2
|
11 (2%)
|
2 (1%)
|
12 (3%)
|
25 (2%)
| |
|
Site 3
|
68 (13%)
|
39 (25%)
|
120 (29%)
|
227 (21%)
| |
|
Site 4
|
51 (10%)
|
12 (8%)
|
54 (13%)
|
117 (11%)
| |
|
Site 5
|
23 (5%)
|
3 (2%)
|
19 (5%)
|
45 (4%)
| |
|
Site 6
|
77 (15%)
|
21 (13%)
|
36 (9%)
|
134 (13%)
| |
|
Site 7
|
81 (16%)
|
26 (16%)
|
34 (8%)
|
141 (13%)
| |
|
Site 8
|
120 (24%)
|
26 (16%)
|
52 (13%)
|
198 (18%)
| |
|
Site 9
|
47 (9%)
|
16 (10%)
|
32 (8%)
|
95 (9%)
| |
- Data are n (%) unless otherwise stated, ^p values are for differences in % across the three groups from chi-squared tests
