Chemotherapy-naive metastatic castration-resistant prostate cancer
Conditions
Sponsors
Takeda Pharmaceutical Company Limited
Millennium Pharmaceuticals, Inc., U.S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma - Radiograph-documented metastatic disease - Progressive disease - Prior surgical castration or concurrent use of an agent for medical castration - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion criteria
Exclusion criteria: - Received prior chemotherapy for prostate cancer - Documented central nervous system metastases - Current spinal cord compression, bilateral hydronephrosis or current bladder neck outlet obstruction - Uncontrolled cardiovascular condition as specified in study protocol - Uncontrolled nausea, vomiting or diarrhea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic progression-free survival (rPFS), Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 50% prostate specific antigen (PSA) response, Changes in circulating tumor cell (CTC) counts, Time to pain progression | — |
Outcome results
None listed