Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

abiraterone acetate tablets (II): 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• SAE — 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
  Serious adverse event
• TEAE — 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
  Adverse events caused by treatment

Trial sites (1)

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China