Table 2.
Surrogate endpoint | Total No. | Treatment failure events |
Median PCSS time |
||||
Control arm, No. (%) | Experimental arm, No. (%) | OR (95% CI) | Control arm, y | Experimental arm, y | HR (95% CI) | ||
3-y Analysis | |||||||
DM | |||||||
Yes | 88 | 61 (9) | 27 (4) | 2.36 (1.48 to 2.76) | 5.46 | 5.77 | 0.95 (0.60 to 1.50) |
No | 1276 | 624 (91) | 652 (96) | 10.08 | 10.21 | 0.76 (0.51 to 1.11) | |
Total | 1364 | 685 (50) | 679 (50) | 9.58 | 9.91 | 0.69 (0.52 to 0.93) | |
GCTF | |||||||
Yes | 412 | 235 (34) | 177 (26) | 1.48 (1.17 to 1.88) | 8.46 | 8.80 | 0.81 (0.58 to 1.14) |
No | 952 | 450 (66) | 502 (74) | 10.29 | 10.31 | 0.88 (0.48 to 1.63) | |
Total | 1364 | 685 (50) | 679 (50) | 9.58 | 9.91 | 0.69 (0.52 to 0.93) | |
5-y Analysis | |||||||
DM | |||||||
Yes | 74 | 44 (8) | 30 (5) | 1.52 (0.94 to 2.45) | 8.55 | 7.70 | 1.35 (0.65 to 2.78) |
No | 1104 | 543 (92) | 561 (95) | 10.39 | 10.53 | 0.70 (0.47 to 1.04) | |
Total | 1178 | 587 (50) | 591 (50) | 8.17 | 10.47 | 0.73 (0.52 to 1.04) | |
GCTF | |||||||
Yes | 418 | 239 (41) | 179 (30) | 1.58 (1.24 to 2.01) | 9.85 | 10.28 | 0.85 (0.56 to 1.30) |
No | 760 | 348 (59) | 412 (70) | 10.54 | 10.52 | 0.84 (0.45 to 1.57) | |
Total | 1178 | 587 (50) | 591 (50) | 10.35 | 20.50 | 0.73 (0.52 to 1.04) |
PCSS = prostate cancer–specific survival; Control arm = short-term androgen deprivation and radiation therapy arm; Experimental arm = long-term androgen deprivation and radiation therapy arm; OR = odds ratio of distant metastasis or general clinical treatment failure event; HR = hazard ratio of prostate cancer–specific death; CI = confidence interval; DM = distant metastasis; GCTF = general clinical treatment failure.