Prostate adenocarcinoma confirmed by initial histological or cytological examination.
Conditions
Interventions
Test group:Abiraterone acetate tablets (II)+ Docetaxel +Prednisone
Sponsors
The First Affiliated Hospital of Ningbo University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, = 90 g/L; b. Absolute Neutrophil Count (ANC) >= 1.5×10^9 /L; c. Platelet Count (PLT) >= 100×10^9 /L; d. Total Bilirubin (TBIL) = 45 ml/min; h. Blood potassium >= 3.5 mmol/L; i. Left Ventricular Ejection Fraction (LVEF) >= 50%. 13. According to the researchers' judgment, able to comply with the trial protocol. 14. For male subjects with a partner who is of childbearing potential, surgical sterilization should be performed or effective contraceptive measures should be taken during the trial and within 4 weeks after the last dose of Abiraterone Acetate (II) or within 6 months after the last dose of Docetaxel chemotherapy. 15. Voluntarily participate in this clinical trial, understand the research procedures, and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. At the time of enrollment, neuroendocrine carcinoma should be excluded. For patients with significantly low PSA and evident local imaging progression, NSE testing should be conducted to exclude patients with NSE levels higher than normal. If necessary, re-biopsy can be performed to rule out neuroendocrine carcinoma through pathology. 2. Previously used ketoconazole, abiraterone acetate, or other investigational drugs that inhibit androgen synthesis for the treatment of prostate cancer. 3. Patients with any underlying disease requiring long-term use of corticosteroids equivalent to prednisone/prednisolone 5mg BID. 4. Plan to accept any other anti-tumor treatment during this trial period. 5. Uncontrolled hypertension (systolic BP >= 160 mmHg or diastolic BP = 95 mmHg; confirmed by 3 consecutive measurements, each spaced 5 minutes apart); 6. The presence of active heart disease within 6 months prior to C1D1, including: severe/uncontrolled angina, myocardial infarction, symptomatic congestive heart failure, and drug-treated ventricular arrhythmias. 7. The patient has used other investigational drugs within 30 days prior to enrollment, or is concurrently participating in other interventional clinical studies. 8. According to the researchers' judgment, there are serious conditions that may jeopardize patient safety, potentially confuse research results, or affect patients' ability to complete this study, such as severe diabetes, neurological or mental disorders, or any other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiational progression-Free-Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prostate-specific antigen;Quality of life;Overall survival;Complete Blood Count;Response Evaluation Criteria in Solid Tumors; | — |
Countries
China
Contacts
Public ContactQi Ma
The First Affiliated Hospital of Ningbo University
Outcome results
None listed