Prostate cancer
Conditions
Interventions
Patients receive 120 mg denosumab every 4 week, and Combined Androgen Blockade (CAB) with LH-RH analog or surgical castration, and anti-androgen.
Patients receive 4 mg zoledronic acid every 4 week, an
Sponsors
Chiba Cancer Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Performance status 0-2 (ECOG) 2.Written informed consent 3.Histologically confirmed prostate cancer, existing radiographic evidence of at least one bone metastasis 4.Patients who satisfy the following (a)WBC>=3000/mm3 (b)AST<=100 IU/L ,ALT<=100 IU/L, Serum creatinine<=2.0 mg/dl, Serum adjusted calcium8.0-10.0mg/dl
Exclusion criteria
Exclusion criteria: 1.Patients who had prior bisphosphonate 2.Patients who are on hemodialysis 3.Patients who are treated with chemotherapy 4.Patients with poorly controlled hepatic disorder or renal dysfunction or diabetes 5.Patients who are receiving or planning treatment of tooth extraction or dental implant for oral infeciton 6.Patients who considered inappropriate for this trial by physicians
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Serum PSA Serum Ca Skeltal related events Progression-free survival Over all survival Adverse events QOL | — |
Primary
| Measure | Time frame |
|---|---|
| Biochemical markers of bone turnover(serum NTx,BAP) | — |
Countries
Japan
Contacts
Public ContactAtsushi Komaru
Chiba Cancer Center Urology
Outcome results
None listed