Clinical Trial

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

Study acronym: prostate
Active, Not Recruiting
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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.
Trial Details
NCT Number NCT07721532
Lead Sponsor The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd., Northern Jiangsu People's Hospital
Conditions Diagnosed With Metastatic Prostate Cancer
Enrollment 3,000 participants
Start Date 2025-01-08
Primary Completion 2027-12-21 (estimated)
Study Completion 2027-12-21 (estimated)
Updated on ClinicalTrials.gov 2026-07-23