Impact of local therapy for metastatic prostate cancer
- Conditions
- metastatic prostate cancer
- Registration Number
- JPRN-UMIN000034795
- Lead Sponsor
- Hirosaki University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 50
Not provided
Refuses to give informed consent Deemed to have unresectable disease by surgeon Received ADT for more than 6 months prior to randomization Life expectancy of less than 6 months prior to randomization Known spinal cord compression M1c disease (solid organ metastasis) Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to randomization Previous local therapy for prostate cancer Previous chemotherapy for prostate cancer Patients who have chemotherapy, radiotherapy or oral antifungal agents (ketoconazole, itraconazole, fluconazole) within 3 weeks prior to entering the study or those who have not recovered (e.g. back to baseline or grade 1) from adverse events due to agents administered more than 3 weeks earlier Any drug interactions that are deemed to be medically significant would require a washout of 5-half-lives of the interaction agent before enrollment can occur
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Progression-free survival PSA response Objective response