androgen deprivation treatment-naive nonmetastatic prostate cancer
Conditions
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)Patient has histologically or cytologically confirmed prostate adenocarcinoma 2)Patients who have not received androgen deprivation treatment (e.g., GnRH agonist, GnRH antagonist, steroidal antiandrogen, non-steroidal androgen) for prostate cancer. 3)Patients who have not undergone surgical castration 4)Serum testosterone at screening > 150 ng/dL 5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
Exclusion criteria: 1)Patients who have received 5-alpha reductase inhibitors 2)Patients who have received chemotherapy for prostate cancer (including Estramustine) 3)Patients who have received 125I-brachytherapy radiation therapy 4)Diagnosis or treatment for another systemic malignancy within 2 years before the first dose. Patients who diagnosed with another malignancy and any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type will not be excluded if they have undergone complete resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT, adverse events, clinical laboratory tests, vital signs, and 12-lead ECGs Up to 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations of TAK-385, Serum testosterone concentration, Serum prostate-specific antigen (PSA) Up to 48 weeks | — |
Outcome results
None listed