Castration resistant prostate cancer
Conditions
Interventions
Abiraterone
Enzalutamide
Sponsors
Department of Urology Wakayama Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Castration resistant prostate cancer patients with or without metastasis after at least one kind of anti-androgen therapy who are unfit for docetaxel chemotherapy. 2. PSA less than 5ng/ml 3. Under 85 years old 4. ECOG PS is 0-2 and at least 3 months of survival is expected. 5. Appropriate visceral function WBC > 3000/mm3 or Neutrophils > 1500/mm3 AST, ALT <upper limit of normal range X 1.5 sCr < upper limit of normal range X 1.5 6. Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: Not specifically defined.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response rate in each group of abiraterone and enzalutamide as primary therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PSA or radiographic progression free rate in each group of abiraterone and enzalutamide as primary therapy 2. PSA response rate in each group of abiraterone and enzalutamide as primary therapy 3. PSA or radiographic progression free rate in each group of abiraterone and enzalutamide as whole therapy after cross-over 4. Time until introduction of chemotherapy or best supportive care (BSC) 5. Overall survival time 6. QOL analysis by FACT P 7. Adverse events in each group of abiraterone and enzalutamide | — |
Countries
Japan
Contacts
Public ContactIsao Hara
Wakayama Medical University Department of Urology
Outcome results
None listed