Japanese research for patients with non-metastatic castration resistant prostate cancer - enzalutamide
- Conditions
- on-metastatic castration resistant prostate cancer
- Registration Number
- JPRN-UMIN000018964
- Lead Sponsor
- Kagawa University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 60
Not provided
1) Patients with history of any chemotherapy (including estramustine phosphate sodium hydrate (JAN)), or treatment with enzalutamide or abiraterone acetate 2) Patients with history of steroid usage as treatment for prostate cancer 3) Patients with history of 5-alpha-reductase inhibitor, estrogen or steroidal antiandrogen within past 4 weeks prior to initial administration of enzalutamide 4) Patients with history of malignant tumor other than prostate cancer within past 3 years 5) Patients with history of seizure or predisposing disease of seizure 6) Patients with severe liver dysfunction 7) Patients with a previous history of hypersensitivity to any component of drugs which will be administered in this study 8) Patients who considered to be inappropriate for the study participation by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prostate specific antigen-progression-free survival (PSA-PFS)
- Secondary Outcome Measures
Name Time Method 1) Overall survival (OS) 2) Progression-free survival (PFS) 3) Metastasis free survival (MFS) 4) Time to prostate-specific antigen (PSA) progression (TTPP) 5) PSA response rate 6) Time to first use of chemotherapy (TFC) 7) Quality of life assessment using Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales 8) Medication adherence 9) Safety assessment on the incidence and severity of adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0