Prostate Cancer
Conditions
Interventions
Abiraterone Acetate (II) + ADT + Chemotherapy Group:ADT administration: Administer according to the standard dose of the selected drug
Abiraterone acetate tablets (II) administration: Orally, 300 mg once a day, combined with prednisone or prednisolone 5 mg orally twice a day
Docetaxel administration: Chemotherapy should be initiated within 4 weeks after the administration of ADT + abiraterone acetate tablets (II), via intravenous infusion, 75 mg/m2, once every three weeks
Sponsors
Affiliated Hospital of Guizhou Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. ECOG score of 0 or 1; 3. Prostate cancer confirmed by pathology or histocytology; 4. Patients with mCRPC who progressed after receiving novel endocrine therapy in the previous stage; 5. Bone metastases or metastases shown by CT/MRI scans, with acceptable visceral metastases; 6. Radiographic or PSA progression occurs during continuous androgen deprivation therapy (ADT) or after orchiectomy; 7. After achieving castration level with androgen deprivation therapy, prostate-specific antigen increases continuously for 3 times at an interval of 1 week, with an increase of > 50% compared with the lowest level; 8. Expected survival time of more than half a year; 9. Organ function levels must meet the following requirements (no blood transfusion or hematopoietic growth factor therapy within 2 weeks before blood routine screening): • ANC >= 1.5 × 10?/L; • PLT >= 100 × 10?/L; • Hb >= 90 g/L; • TBIL = 50%; • QTcF <= 450 ms. 10.Subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use effective contraceptive methods during the study and within 3 months after the last drug treatment; 11.Subjects voluntarily participate in this study, sign the written informed consent form, and are expected to have good compliance with the study protocol.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions are not eligible for enrollment in this study: 1. Previous chemotherapy for prostate cancer; 2. Patients who have progressed after previous abiraterone treatment; 3. Received other investigational drug treatments or major surgeries within 4 weeks before enrollment; 4. Presence of inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug administration and absorption; 5. A history of epilepsy, or diseases that could induce epileptic seizures within 12 months before randomization (including a history of transient ischemic attack, stroke, or traumatic brain injury with disturbance of consciousness requiring hospitalization); 6. Presence of active heart disease within 6 months before randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure (NYHA class III or IV) and ventricular arrhythmias requiring drug treatment; 7. Patients with active HBV or HCV infection (HBsAg positive with viral load >= 500 IU/mL, HCV antibody positive with HCV RNA above the lower limit of detection of the analytical method); 8. Known history of allergy to the study drug or its components; 9. Complicated with other malignant tumors; 10. According to the investigator's judgment, there are concomitant diseases (such as poorly controlled hypertension, severe diabetes, neurological or psychiatric diseases, etc.) or any other conditions that seriously endanger the patient's safety, may confuse the study results, or affect the subject's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression-Free Survival (rPFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA response rate; Overall survival (OS);Objective response rate (ORR);Quality of life ;Safety; | — |
Countries
China
Contacts
Public ContactGe Huixin
Affiliated Hospital of Guizhou Medical University
Outcome results
None listed