Patient with castration resistant prostate cancer
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Provided written informed consent - Histologically confirmed prostate cancer with adenocarcinoma. - Satisfy the following definition of castration resistance. Castrate serum testosterone level:50 ng/dL or less Bilateral orchiectomy or maintenance on androgen ablation therapy with LHRH agonist or antagonist Disease or PSA progression - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion criteria
Exclusion criteria: - A serious illness or medical condition. - Hypersensitivity to any drugs similar to TAS-115 in structure or class. - History of other primary malignancy in the last 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Efficacy Bone Navi | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy, Safety RECIST(Ver.1.1), PCWG3, CTCAE(Ver.4.03) | — |
Countries
Japan