Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- SAE
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Queue One & Queue Two: Age ≥ 18 years
- •Queue One & Queue Two: Diagnosed with metastatic prostate cancer
- •Queue One: Researchers assess eligibility to use abiraterone acetate tablets (II) for treatment, or previous use, or ongoing treatment with abiraterone acetate tablets (II)
- •Queue One: Sign informed consent and voluntarily join this study
- •Queue 1: Male patients whose partners are women of childbearing potential should undergo surgical sterilization or agree to use effective contraception during the trial and for 3 weeks after the last administration of the study drug.
- •Queue Two: Previously used ordinary Abiraterone Acetate tablets continuously for more than 3 cycles
- •Queue 2: At least one efficacy assessment after medication
Exclusion Criteria
- •Queue One: Patients with severe liver dysfunction (Child-Pugh Class C)
- •Queue One: Currently participating in other clinical studies related to abiraterone acetate tablets (II)
- •Queue One & Queue Two: Researchers determine other situations that are not suitable for inclusion in the study
- •Queue Two: Patients with severely missing medical record data
Arms & Interventions
Queue Two
- Age ≥18 years old;
- Diagnosed with metastatic prostate cancer;
- Previously used abiraterone acetate tablets continuously for more than 3 cycles;
- At least one efficacy evaluation after medication.
Queue One
- Age ≥ 18 years old;
- Diagnosed with metastatic prostate cancer;
- 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;
- Sign the informed consent and voluntarily join this study;
- 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.
Intervention: abiraterone acetate tablets (II) (Drug)
Outcomes
Primary Outcomes
SAE
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
Serious adverse event
TEAE
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
Adverse events caused by treatment
Secondary Outcomes
- DOT(1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year)
- rPFS(1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year)
- OS(1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year)
- PSA(1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year)