← Back to all trials
Active Not Recruiting
NCT07721532
Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
Conditions: Diagnosed With Metastatic Prostate Cancer
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3000
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Location: Nanjing Drum Tower Hospital Nanjing
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 Criteria
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
Source: ClinicalTrials.gov (NCT07721532). StuddyBuddy aggregates publicly available trial information.