prostate cancer
Conditions
Interventions
Experimental group:Prednisone 5 mg and Apalutamide Tablets 240 mg/day
Control group:Apalutamide Tablets 240 mg/day
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Metastatic prostate adenocarcinoma confirmed by pathology, excluding neuroendocrine carcinoma, small cell carcinoma of the prostate or ductal carcinoma; 2. Distant metastases confirmed by CT, bone scan or MRI; 3. Confirmed to be in the hormone-sensitive stage. The definition of hormone sensitivity: the patient is at the castration level after castration therapy and anti-androgen therapy, and there is a remission of imaging or PSA; 4. The previous = 2 x 10^9/L and platelet count >= 100 x 10^9/L and hemoglobin >= 9 g/dL; 8. Adequate liver function: total bilirubin = 60 mL/min; 10. Life expectancy greater than 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with prednisone contraindications; 2. Combined with any chronic disease that needs to be treated with prednisone once a day at a dose of more than 5 mg; 3. History of hypersensitivity or intolerance to any drug used in the study; 4. The patient has the possibility of childbearing but is unwilling or has not taken effective contraceptive measures; 5. Any uncontrolled systemic disease, including active infection, active autoimmune disease, uncontrolled cardiovascular and cerebrovascular diseases, such as hypertension, diabetes, myocardial infarction, cerebral infarction, etc.; 6. 5 years of history of other malignant tumors; 7. Poor compliance, unable to cooperate with treatment and follow-up; 8. Participated in other clinical research in the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of rash; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate specific antigen, PSA ;Adverse events; | — |
Countries
China
Contacts
Public ContactLi Jun
Sichuan Provincial People's Hospital
Outcome results
None listed