prostate cancer
Conditions
Interventions
single arm:abiraterone+ dutasteride+ prednisone
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Patients over the age of 18 who signed the informed consent. 2) Prostate adenocarcinoma was confirmed by histology or cytology. 3) Patients were castrated resistant prostate cancer patients (serum testosterone = 12 months. 6) Patients were able to swallow the study drug and comply with the study requirements. 7) Patients agree to use condoms and other effective contraceptive methods having sex with a fertile woman 8) Patients agreed not to participate in other intervention studies during the treatment period.
Exclusion criteria
Exclusion criteria: 1) Patients had previously received new androgen receptor inhibitors such as enzalutamide or apalutamide. 2) The histologic features were special types such as small cell carcinoma of prostate, sarcoma of prostate, and so on. 3) Patients had a history of aggressive cancer within 3 years before screening. 4) At the time of screening, total bilirubin >= 1.5 * normal upper limit or alanine aminotransferase >= 2.5 * normal upper limit. 5) The creatinine of the subjects was more than 442 umol / L at the time of screening. 6) Subjects were in active infection or other medical conditions in which prednisone was contraindicated. 7) At the time of screening, the patients had uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg for at least two consecutive blood pressure measurements).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA decrease range;overall survival;bone events; | — |
Countries
China
Contacts
Public ContactWU DENGLONG
Shanghai Tongji Hospital
Outcome results
None listed