bone metastatic prostate cancer
Conditions
Interventions
ZA group:Zoledronic acid+MAB
non-ZA group:Zoledronic acid+MAB
Sponsors
West China Hospital, SiChuan University
Eligibility
Sex/Gender
Male
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. To be aged 40 years or older; 2. disease diagnosed by histopathology proved prostate cancer; 3. SPECT body bone scan: the bone metastasis; 4. Eastern Cooperative Oncology Group physical status score =1; 5. the expected survival >3 months; 6. blood RBC =1.5*10*9 platelet=100*10*9, hemoglobin =90g/L; 7. blood biochemical indexes: liver function: bilirubin = 1.5 times the upper limit of normal, AST = 2.5 times the upper limit of normal; serum creatinine =1.5 times the upper limit of normal serum calcium concentration: =12mg/dL; 8. coagulation function: PT = 1.5 times the upper limit of normal; 9. the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina, congestive heart failure, stroke or transient ischemic attack; 10. all the patients signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. previous or simultaneous with other malignant tumors, but except the patients with cancers, including cervical intraepithelial were basal cell carcinoma, the full treatment of superficial bladder tumor (Ta, Tis, T1) or occurring before entering the group and have been cured more than 3 years; 2. there are other tumor induced bone metastasis; 3. renal decompensation need hemodialysis or peritoneal dialysis; 4. arrhythmia requiring antiarrhythmic therapy, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction occurred in recent 6 months) or congestive heart failure than NYHA grade II; received 2 or more antihypertensive therapy has failed to control high blood pressure (systolic or diastolic blood pressure of >160mmHg >100 mmHg); 5. severe active clinicalinfection; 6. with coagulation disorders or bleeding physique; 7. received a large operation or serious injury before entering the group in 4 weeks; 8. with allogeneic organ transplantation or bone marrow transplantation history; 9. drug abuse and medical, psychological or social conditions of patients participated in the study of interference or the results of the assessment may be; 10. with known or suspected of drug allergy; 11. enrolled in this study during the first 4 weeks of the study and research to accept treatment outside the party.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| keletal related events free survival, SFS;overall survival, OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival, PFS;PSA level;BMI; | — |
Countries
China
Contacts
Public ContactZeng Hao
West China Hospital, Sichuan University
Outcome results
None listed