castration-resistant prostate cancer
Conditions
Interventions
enzalutamide 160mg
abiraterone 1000mg
Sponsors
Kanazawa University Graduate School of Medical Science, Department of Integrative Cancer Therapy and Urology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Pathologically or cytologically confirmed castration-resistant prostate cancer defined as total testosterone <50 ng/dl and two consecutive PSA elevatoin with 1week interval and the PSA judged is at least 2ng/ml higher than nadir. 2. No previous cytotoxic intravenous systemic chemotherapy 3. >=20 years old 4. ECOG PS 0-2 5. Total bilirubin <=1.5xUpper Limit of Normal (ULN), aspartate transaminase <=2.5xULN (<=5.0xULN in patients with liver metasiasis), alanine transaminase <=2.5xULN (<=5.0xULN in patients with liver metasiasis), no ascites, and no hepatic encephalopathy 6. Serum creatinine <=2.0xULN 7. Life expectancy >3months 8. Obtained infromed consent with document
Exclusion criteria
Exclusion criteria: 1. Allergy for enzalutamide, abiraterone, and prednisolone 2. Desire to bear children 3. Patients who were judged unfit for enrollment by physicians in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to PSA progression; TTPP | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, radiographic progression-free survival, time to cytotoxic chemotherapy initiation, time to stage-up of ECOG performance status, time to opioid analgesic initiation, PSA response rate | — |
Countries
Japan
Contacts
Public ContactKouji Izumi
Kanazawa University Graduate School of Medical Science Department of Integrative Cancer Therapy and Urology
Outcome results
None listed