Table 3. Patient Characteristics.
| RADICALS-RT(5) | GETUG-AFU 17(6) | RAVES(7) | ||||
|---|---|---|---|---|---|---|
| ART | SRT | ART | SRT | ART | SRT | |
| Patients randomised | 697 | 699 | 212 | 212 | 166 | 167 |
| Median follow up (range) | 60 months (2-132 months) | 75 months (0 – 130 months) | 78 months (1- 122 months) | |||
| Median Age (interquartile range) | 65 (60-68) | 65 (60-68) | 64 (60-68) | 64(59-68) | 64 (60-68) | 64 (59 – 68) |
| Median pre-operative PSA (interquartile range) | 7.8 (5.8-11.4) | 8.0 (5.6-11.6) | Not available | Not available | 7.4 (5.5-10.2) | 7.4 (5.3 – 10.4) |
| Stage | ||||||
| pT2 | 163 (23%) | 176 (25%) | 0 | 0 | 37 (22%) | 39 (23%) |
| pT stage 3a/b | 529 (76%) | 519 (74%) | 208 (99%) | 206 (98%) | 129 (78%) | 128 (77%) |
| pT4 | 5 (1%) | 4 (1%) | 3 (1%) | 5 (2%) | 0 | 0 |
| Gleason score | ||||||
| ≤6 | 48 (7%) | 48 (7%) | 21 (10%) | 22 (10%) | 8 (5%) | 8 (5%) |
| 7 | 537 (77%) | 528 (76%) | 173 (82%) | 167 (78%) | 132 (80%) | 134 (80%) |
| ≥8 | 112 (16%) | 123 (17%) | 17 (8%) | 23 (11%) | 26 (16%) | 25 (15%) |
| Positive margins | 439 (63%) | 443 (63%) | 211 (100%) | 210 (100%) | 110 (66%) | 113 (68%) |
| Seminal vesicle involvement | ||||||
| Yes | 129 (19%) | 132 (19%) | 44 (21%) | 46 (22%) | 31 (19%) | 33 (20%) |
| No | 568 (81%) | 567 (81%) | 167 (79%) | 165 (78%) | 135 (81%) | 134 (80%) |
| Unknown | 0 | 0 | 1 | 1 | 0 | 0 |
| Extracapsular extension | ||||||
| Yes | 492 (71%) | 483 (69%) | 212 (100%) | 212 (100%) | 129 (78%) | 128 (77%) |
| No | 205 (29%) | 215 (31%) | 0 | 0 | 37 (22%) | 39 (23%) |
| Unknown | 0 | 1 | 0 | 0 | 0 | 0 |
| Lymph node involvement | ||||||
| Involved | 38 (10%) | 28 (7%) | 0 | 0 | 1 (<1%) | 0 |
| Not involved | 335 (90%) | 374 (93%) | 212 (100%) | 212 (100%) | 165 (99%) | 167 (100%) |
| Nx | 324 | 297 | 0 | 0 | 0 | 0 |
| CAPRA-S Risk group* | Not estimable | Not estimable | ||||
| Low (0-2) | 58 (8%) | 55 (8%) | 22 (13%) | 21 (13%) | ||
| Intermediate (3-5) | 382 (55%) | 384 (55%) | 100 (60%) | 98 (59%) | ||
| High (6+) | 257 (37%) | 260 (37%) | 44 (27%) | 48 (29%) | ||
*
The GETUG AFU-17 trial did not record pre-operative PSA levels and therefore, CAPRA-S scores(18) which comprise scores based on a number of patient and disease characteristics at baseline, including pre-operative PSA levels, cannot be calculated for the trial.
PSA= prostate specific antigen; ART= Adjuvant radiotherapy; SRT = early salvage radiotherapy