Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07721532). StuddyBuddy aggregates publicly available trial information.