NCT07721532Active, not recruiting
Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 10 Apr 2026
- Start date
- 8 Jan 2025
- Primary completion date
- 21 Dec 2027
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Prostate cancer
- NCT number
- NCT07721532
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 8 Jan 2025 to the primary completion date, 21 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Drum Tower hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.