Table 1.
Trial parameter | TROPIC | COU-AA-301 | Comment |
---|---|---|---|
Comparator | Mitoxantrone | Placebo | Mitoxantrone is an active agent, used in mCRPC for symptom palliation2 |
Geographical range | North America, South America, Australia, Europe, Asia, Africa | North America, Australia, Europe | Inclusion of less developed countries brings potential for wide variation in patient care |
Definition of disease progression | Evidence of PSA progression OR radiological progression OR symptomatic progression | Composite of PSA, radiological AND symptomatic progression | Potential that some TROPIC patients were responding to treatment when taken off study |
mCRPC: metastatic castration-resistant prostate cancer; PSA: prostate-specific antigen.