castration resistant prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)CRPC patients undergoing ADT with GnRH antagonists,agonist or bilateral orchiectomy 2) Testosterone levels of less than 50 ng/dL 3) 25% increase in PSA from nadir (and by 2 ng/mL) which is confirmed 4 weeks later 4) ECOG PS 0-2 5) Signed written informed consent
Exclusion criteria
Exclusion criteria: 1) Severe cardiac function disorders, hepatic function disorders, renal function disorders, infectious disease or hematopoietic disorders 2) Hypersensitivity to study medication 3) History of seizure or any condition that may predispose to seizure 4) Age <20 years 5) History of treatment with Enzalutamide, Abiraterone or chemotherapy 6) Patients whom the investigator judges inappropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SMAC, CBC, serum PSA, cytokines, androgens, Lipid metabolism. Bone markers, QoL assessment PSA-PFS | — |
Countries
Japan
Contacts
Keio University School of Medicine Department of Urology