Table 1 Clinical outcome definitions used in the STRIVE and TERRAIN trials
Outcomes | STRIVE | TERRAIN |
|---|---|---|
PFS | Time from randomization to the earliest objective evidence of PSA progression, radiographic disease progression, or death, whichever occurred first | Time from randomization to the first progression event (i.e. the earliest incidence of centrally determined radiographic disease progression, a skeletal-related event, or initiation of a new antineoplastic therapy) or death, whichever occurred first |
rPFS | Time from randomization to the first objective evidence of radiographic disease progression or death, whichever occurred first | Time from randomization to the first objective evidence of radiographic disease progression or death, whichever occurred first. Radiographic progression in bone at or after Week 13 required a confirmatory bone scan |
Freedom from PSA progression | Time from randomization to the earliest evidence of PSA progression, as per PCWG2 guidelines. PSA progression was defined as a > 25% increase in PSA with an absolute increase of > 2 ng/mL above the nadir | Time from randomization to the earliest evidence of a confirmed PSA progression, as per PCWG2 guidelines. PSA progression needs to be confirmed by a second consecutive value obtained ≥3 weeks later |