Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01546623 | A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy | PHASE3 | COMPLETED | 160 | — | — | Mar 1, 2012 | Apr 1, 2014 | Jul 21, 2015 | 16 | Japan |
Comparison of the proportion of patients maintained at castration level (≤100 ng/dL)
| Arm | Type | Description |
|---|---|---|
| TAP-144-SR(6M) | EXPERIMENTAL | TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks. |
| TAP-144-SR(3M) | ACTIVE_COMPARATOR | TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks. |
| Name | Type | Description |
|---|---|---|
| TAP-144-SR(6M) | DRUG | - |
| TAP-144-SR(3M) | DRUG | - |
Inclusion Criteria: 1. The participant has histopathologically confirmed prostate cancer in Japanese. 2. The participant has prostate cancer in the clinical stages of T1b-T4, N-any and M-any by TNM classification on clinical diagnosis at the time of diagnosis. 3. The participant has ECOG performanc...