castration resistant prostate cancer
Conditions
Interventions
Patients is treated with abiraterone (1,000 mg daily) and prednisone (5 mg daily) for two 4-week cycles. After this time, dutasteride (0.5 mg daily) is added for 12 weeks. Patients continue on the thr
Sponsors
Department od Urology, Yamaguchi Graduate School of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1)advanced prostate cancer (>stage III) with androgen deprivation therapy 2)a serum total testosterone <50 ng/dL 3)PSA progression as defined by the Prostate Cancer Clinical Trials Working Group 4)patients with benign prostate hyperplasia (IPSS>9) 5) Hematologic and laboratory criteria including White blood cell >3,000/mm3 Hemoglobin>8.0 g/dL Platelet count>100000/mm3 aspartate aminotransferase (AST) <100 IU/L alanine aminotransferase (ALT) <100 IU/L Serum creatinine <1.5 mg/dL patients provide written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients took 5alpha-reductase inhibitors previously 2)AST >101 IU/L or ALT>101 IU/L or Child-Pugh score C 3)HbA1c > 10% 4)serum potassium < 3.5 mEq/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the rate of patients with over fifty percent reduction in PSA | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-treatment failure | — |
Countries
Japan
Contacts
Public ContactKeita Kobayashi
Yamaguchi Graduate School of Medicine Urology
Outcome results
None listed