Table 2.
PSA-Progression Definition* | Trial |
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---|---|---|---|---|---|---|---|---|
S9346 (HSPC) |
S9916 (CRPC) |
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Events |
PSA PFS (months)† |
Events |
PSA PFS (months)† |
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No. | % | Median | 95% CI | No. | % | Median | 95% CI | |
Rising trend increase | 669 | 62 | 14.5 | 12.3 to 16.6 | 458 | 77 | 5.7 | 5.0 to 6.2 |
50% + 5‡ | 435 | 40 | 64.1 | NA§ | 346 | 58 | 11.7 | 10.8 to 12.6 |
25% + 5‡ | 440 | 41 | 61.5 | NA§ | 396 | 66 | 9.5 | 8.4 to 10.5 |
PSAWG 1999 (25% + 5; or, if PSA declined by ≥ 50%, 50% + 5)‡ | 435 | 40 | 64.1 | NA§ | 380 | 64 | 10.2 | 9.2 to 11.3 |
PCWG 2008 (25% + 2)‡ | 528 | 49 | 36.1 | 30.5 to 44.2 | 415 | 70 | 8.1 | 7.0 to 9.5 |
Abbreviations: PSA, prostate-specific antigen; PFS, progression-free survival; HSPC, hormone-sensitive prostate cancer; CRPC, castration-resistant prostate cancer; PSAWG, Prostate-Specific Antigen Working Group; PCWG, Prostate Cancer Working Group.
All definitions are based on increases above the prostate-specific antigen nadir.
Kaplan-Meier estimates, in months.
50% + 5 indicates an increase of prostate-specific antigen by ≥ 50% and an absolute increase of ≥ 5 ng/mL; 25% + 5 indicates an increase by ≥ 25% and ≥ 5 ng/mL; 25% + 2 indicates an increase by ≥ 25% and ≥ 2 ng/mL.
95% confidence intervals not estimable when too few prostate-specific antigen progression events were observed.