A Phase 2, Open-label, Single-arm Study of TAK-700 (orteronel) in Patients With Nonmetastatic Castration-resistant Prostate Cancer and Rising Prostate-specific Antige
Phase 2
- Conditions
- onmetastatic castration-resistant prostate cancer (CRPC) with rising prostate-specific antigen (PSA)
- Registration Number
- JPRN-jRCT2080221969
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 30
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma
- No radiographic evidence of metastasis confirmed
- PSA rising defined as the following: increase in PSA
- Prior surgical castration or concurrent use of an agent for medical castration
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria
- Received prior chemotherapy for prostate cancer
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method