castration-resistant prostate cancer with bone metastases
Conditions
Interventions
Radium-223 dichloride (55 kBq/kg) on day 1 every 4 weeks
Sponsors
National Hospital Organization Saitama Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Confirmation of castration-resistant prostate cancer and bone metastases 2) Age from 20 to 80 years old 3) Preserved hematologic function within 28 days as follows; i) neutrophile count >=1,500/mm3 ii) hemoglobin >= 10.0 g/dL iii) platelet count >=100,000/mm3 4) Written informed consent is taken.
Exclusion criteria
Exclusion criteria: 1) organ metastases excluding bone metastases 2) active concomitant malignancy 3) inflammatory bowel disease (Crohn's disease or ulcerative colitis) 4) use of chemotherapy with myelosuppresion reaction at the same time 5) difficult to participate with the trial, having mentel disorder or psychiatric symptoms 6) immuno-suppression treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change rate of PSA at six month after completion of Radium-223 dichloride therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of Adverse events, improvement rate of pain from bone metastases, bone metastases progressive free survival, distant metastases free survival excluding bone metastases, pattern of progression, overall survival | — |
Countries
Japan
Contacts
Public ContactTetsuo Momma
National Hospital Organization Saitama Hospital Urology
Outcome results
None listed