Objectives of Study： Primary Objective: To observe and evaluate the safety of abiraterone acetate tablets (II) and conventional abiraterone tablets in patients with metastatic prostate cancer under real-world conditions, including the types, incidence, and severity of treatment-related adverse events. Secondary Objectives: 1) To observe and evaluate the efficacy of abiraterone acetate tablets (II) and conventional abiraterone tablets in patients with metastatic prostate cancer under real-world conditions, including PSA response, radiographic progression-free survival (rPFS), overall survival (OS), etc.; 2) To observe the adherence of metastatic prostate cancer patients to abiraterone acetate tablets (II) and conventional abiraterone tablets under real-world conditions, including dosage and duration of treatment (DOT); 3) To observe the impact of baseline characteristics of different prostate cancer patients on treatment outcomes, such as ECOG PS score, PSA value, Gleason score, tumor burden, quality of life, etc.; 4) To preliminarily evaluate and compare the pharmacoeconomics of abiraterone acetate tablets (II) and conventional abiraterone tablets in treating Chinese patients with metastatic prostate cancer.
Study Type
OBSERVATIONAL
Enrollment
3,000
1. Age ≥ 18 years old; 2. Diagnosed with metastatic prostate cancer; 3. Researchers assess that the patient can use abiraterone acetate tablets (II) for treatment, or has previously received, or is currently receiving abiraterone acetate tablets (II) treatment; 4. Sign the informed consent and voluntarily join this study; 5. Male patients with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the trial and for 3 weeks after the last administration of the study drug.
Nanjing Drum Tower Hospital
Nanjing, China
SAE
Serious adverse event
Time frame: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
TEAE
Adverse events caused by treatment
Time frame: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
DOT
Compliance indicators: duration of medication (DOT);
Time frame: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
rPFS
Relapse-Free Survival
Time frame: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
OS
overall survival
Time frame: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
PSA
PSA response rate
Time frame: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
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