prostate cancer
Conditions
Interventions
test group:Use dexamethasone
Control group:use prednisone
Sponsors
Fudan University Cancer Center.
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years old; 2) Estimated survival period > 12 months; 3) Docetaxel treatment before treatment, but the condition is still progressing; 4) Have not received chemotherapy or endocrine therapy before; 5) Have undergone prostate puncture examination and confirmed by pathology as prostate cancer; 6) bone scan confirmed bone metastasis > 5 units; 7) normal bone marrow function, blood neutrophils = 1.5x10^9/L, hemoglobin = 100g/L, platelets = 100x10^9/L; 8) normal liver and kidney function, blood AST=60U/L, total bilirubin =2.5 times the upper limit of normal value, serum creatinine =110µmol/L, urea nitrogen =7.1mmol/L; 9) Normal heart function, normal ECG and LVEF = 55%; 10) Sign the informed consent form, voluntarily and able to conduct visits, treatments, laboratory tests and other research procedures as planned.
Exclusion criteria
Exclusion criteria: 1) Any systemic treatment (including neoadjuvant and adjuvant chemotherapy, targeted drug therapy, experimental therapy, etc.) has been previously performed for prostate cancer; 2) Patients with previous history of ketoconazole and adrenal or pituitary disease; 3) Pathological fracture of bone metastasis or distant metastasis of prostate cancer has been found; 4) Other malignant tumors (except for controlled cervical carcinoma in situ or basal cell carcinoma of the skin); 5) with uncontrolled lung disease, severe infection, active gastrointestinal ulcer, coagulopathy, severe uncontrolled diabetes, connective tissue disease or inhibition of bone marrow function, can not tolerate adjuvant therapy and related treatment; 6) Peripheral neuropathy caused by any cause > 1 degree; 7) Previously congestive heart failure, uncontrolled or symptomatic angina, arrhythmia or history of myocardial infarction, uncontrollable hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg); 8) Abnormal blood coagulation; 9) Psychiatric patients or other reasons cannot comply with treatment; 10) It is known that there is a history of severe allergies to any drug in the treatment regimen; 11) Patients who have undergone major surgery or severe trauma within 2 months prior to the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS; | — |
Countries
China
Contacts
Public ContactDingwei Ye
Fudan University Cancer Center
Outcome results
None listed