Prostate Cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of prostate cancer was confirmed 2. Stage D (with bone metastasis) prostate cancer 3. Case with tumor marker positive and history of hormonal therapy and that have been receiving zoledronic acid for at least a month. 4. ECOG performance status 0-2 5 Case with multiple bone metastases demonstrated on standard bone scintigraphy, with bone pain localized in the areas of higher up-take. 6. Case with using analgesic such as NSAIDs or opioid for painful bone metastases 7. WBC>3,000/mm3, neutrophil>1,500/mm3, platelet>75,000/mm3, Hb>9.0g/dL, and at a case after chemotherapy or external radiotherapy, the nadir of each parameter is confirmed. 8.Case that DIC is excluded and with no rapid decrease in platelet count 9. Case that survival more than 1 month is anticipated 10.Case signed informed consent of the patients for the registration
Exclusion criteria
Exclusion criteria: 1. Patients with severe renal failure 2. Patients with ongoing chemotherapy 3. Patients with ongoing external radiotherapy 4. Patients with unmanageable urinary incontinence 5. Patients with severe complication 6. Patients with history of drug allergy that are considered inappropriate to conduct this trial 7. Other patients deemed not appropriate for study entry by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (the ratio of responder to bone pain) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and mechanism(changes in the level of tumor marker and bone turnover marker) | — |
Countries
Japan
Contacts
Keio University Shool of Medicine Department of Urology