Table 1.
PBRT Alone (n=564) |
PBRT+STADT (n=578) |
PLNRT+PBRT+ STADT (n=574) |
Total (n=1716) |
|||||
---|---|---|---|---|---|---|---|---|
n | % | n | % | n | % | n | % | |
| ||||||||
Age(Years) | ||||||||
Mean | 63.8 | 63.9 | 63.9 | 63.9 | ||||
Median | 64 | 64 | 64 | 64 | ||||
Min - Max | 42 – 84 | 39 – 80 | 44 – 80 | 39 – 84 | ||||
≤49 | 19 | 3.4 | 15 | 2.6 | 8 | 1.4 | 42 | 2.4 |
50–59 | 118 | 20.9 | 137 | 23.7 | 138 | 24.0 | 393 | 22.9 |
60–69 | 307 | 54.4 | 299 | 51.7 | 307 | 53.5 | 913 | 53.2 |
≥70 | 120 | 21.3 | 127 | 22.0 | 121 | 21.1 | 368 | 21.4 |
Race | ||||||||
American Indian/Alaska Native | 0 | 0.0 | 0 | 0.0 | 5 | 0.9 | 5 | 0.3 |
Asian | 3 | 0.5 | 6 | 1.0 | 8 | 1.4 | 17 | 1.0 |
Black or African American | 74 | 13.1 | 69 | 11.9 | 77 | 13.4 | 220 | 12.8 |
Native Hawaiian or Other Pacific Islander | 1 | 0.2 | 4 | 0.7 | 0 | 0.0 | 5 | 0.3 |
White | 464 | 82.3 | 482 | 83.4 | 474 | 82.6 | 1420 | 82.8 |
More than one race | 3 | 0.5 | 0 | 0.0 | 0 | 0.0 | 3 | 0.2 |
Unknown or not reported | 19 | 3.4 | 17 | 2.9 | 10 | 1.7 | 46 | 2.7 |
Ethnicity | ||||||||
Hispanic or Latino | 21 | 3.7 | 23 | 4.0 | 30 | 5.2 | 74 | 4.3 |
Not Hispanic or Latino | 511 | 90.6 | 527 | 91.2 | 517 | 90.1 | 1555 | 90.6 |
Unknown | 32 | 5.7 | 28 | 4.8 | 27 | 4.7 | 87 | 5.1 |
Zubrod Performance Status | ||||||||
0 | 522 | 92.6 | 539 | 93.3 | 540 | 94.1 | 1601 | 93.3 |
1 | 42 | 7.4 | 39 | 6.7 | 34 | 5.9 | 115 | 6.7 |
Pathologic Seminal Vesicle Involvement | ||||||||
No | 482 | 85.5 | 494 | 85.5 | 488 | 85.0 | 1464 | 85.3 |
Yes | 82 | 14.5 | 84 | 14.5 | 86 | 15.0 | 252 | 14.7 |
Pathological Tumor Stage | ||||||||
T2 | 292 | 51.8 | 317 | 54.8 | 304 | 53.0 | 913 | 53.2 |
pT3 Extraprostatic extension NOS | 13 | 2.3 | 15 | 2.6 | 18 | 3.1 | 46 | 2.7 |
pT3a Extraprostatic extension | 177 | 31.4 | 162 | 28.0 | 166 | 28.9 | 505 | 29.4 |
pT3b Seminal vesicle invasion | 82 | 14.5 | 84 | 14.5 | 86 | 15.0 | 252 | 14.7 |
Gleason | ||||||||
4 | 0 | 0.0 | 1 | 0.2 | 1 | 0.2 | 2 | 0.1 |
5 | 3 | 0.5 | 1 | 0.2 | 5 | 0.9 | 9 | 0.5 |
6 | 80 | 14.2 | 85 | 14.7 | 89 | 15.5 | 254 | 14.8 |
7: 3+4 | 226 | 40.1 | 240 | 41.5 | 221 | 38.5 | 687 | 40.0 |
7: 4+3 | 153 | 27.1 | 148 | 25.6 | 156 | 27.2 | 457 | 26.6 |
7: primary/secondary not indicated | 9 | 1.6 | 5 | 0.9 | 3 | 0.5 | 17 | 1.0 |
8 | 57 | 10.1 | 60 | 10.4 | 57 | 9.9 | 174 | 10.1 |
9 | 36 | 6.4 | 38 | 6.6 | 42 | 7.3 | 116 | 6.8 |
Prostatectomy Margins | ||||||||
Positive | 288 | 51.1 | 289 | 50.0 | 284 | 49.5 | 861 | 50.2 |
Negative | 267 | 47.3 | 284 | 49.1 | 287 | 50.0 | 838 | 48.8 |
Unknown | 9 | 1.6 | 5 | 0.9 | 3 | 0.5 | 17 | 1.0 |
Pelvic Lymphadenectomy | ||||||||
No | 189 | 33.5 | 207 | 35.8 | 209 | 36.4 | 605 | 35.3 |
Yes | 375 | 66.5 | 371 | 64.2 | 365 | 63.6 | 1111 | 64.7 |
Number of Lymph Nodes Examined* | (n=349) | (n=336) | (n=336) | (n=1021) | ||||
Mean | 7.2 | 7.8 | 7.2 | 7.4 | ||||
Median | 5 | 6 | 5 | 6 | ||||
Min - Max | 0 – 34 | 1 – 54 | 1 – 32 | 0 – 54 | ||||
Pre-RT Entry PSA (ng/ml) | ||||||||
Mean | 0.47 | 0.51 | 0.47 | 0.48 | ||||
Median | 0.32 | 0.40 | 0.32 | 0.35 | ||||
Min - Max | 0.1 – 1.96 | 0.1 – 1.93 | 0.1 – 1.93 | 0.1 – 1.96 | ||||
≥ 0.1 and ≤ 0.2 ng/ml | 155 | 27.5 | 126 | 21.8 | 154 | 26.8 | 435 | 25.3 |
> 0.2 and ≤ 0.5 ng/ml | 247 | 43.8 | 256 | 44.3 | 247 | 43.0 | 750 | 43.7 |
> 0.5 and ≤ 1.0 ng/ml | 105 | 18.6 | 130 | 22.5 | 114 | 19.9 | 349 | 20.3 |
> 1.0 and < 2.0 ng/ml | 57 | 10.1 | 66 | 11.4 | 59 | 10.3 | 182 | 10.6 |
Time from Surgery to Randomization | ||||||||
>0 and ≤6 months | 47 | 8.6 | 29 | 5.2 | 26 | 4.6 | 102 | 6.1 |
>6 and ≤12 months | 90 | 16.4 | 111 | 19.8 | 95 | 16.9 | 296 | 17.7 |
>12 and ≤18 months | 55 | 10.0 | 61 | 10.9 | 71 | 12.6 | 187 | 11.2 |
> 18 months | 356 | 65.0 | 361 | 64.2 | 371 | 65.9 | 1088 | 65.0 |
Median (years) | 2.3 | 2.1 | 2.1 | 2.2 | ||||
Min - Max | 0.1 – 20.5 | 0.1 – 17.6 | 0.1 – 17.7 | 0.1 – 20.5 | ||||
Post-operative PSA Doubling Time** | (n=156) | (n=156) | (n=159) | (n=471) | ||||
>0 and ≤6 months | 34 | 21.8 | 32 | 20.5 | 32 | 20.1 | 98 | 20.8 |
>6 and ≤12 months | 54 | 34.6 | 55 | 35.3 | 62 | 39.0 | 171 | 36.3 |
>12 and ≤18 months | 26 | 16.7 | 33 | 21.2 | 27 | 17.0 | 86 | 18.3 |
> 18 months | 42 | 26.9 | 36 | 23.1 | 38 | 23.9 | 116 | 24.6 |
Data are not available for all patients who underwent a lymphadenectomy and these patients were excluded from the lymph node number calculations.
The requirement to record PSA doubling time prior to enrollment was dropped in an amendment to the protocol. Only n=471 values were available.