Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating… (NCT07721532) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
China3,000 participantsStarted 2025-01-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SAE
Timeframe: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
2
TEAE
Timeframe: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
Trial details
NCT IDNCT07721532
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School