Clinical trial · Observational
Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diagnosed With Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| abiraterone acetate tablets (II) | Drug | Abiraterone | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Queue One
- description
- 1. Age ≥ 18 years old; 2. Diagnosed with metastatic prostate cancer; 3. Researchers assess that the patient can use abiraterone acetate tablets (II) for treatment, or has previously received, or is currently receiving abiraterone acetate tablets (II) treatment; 4. Sign the informed consent and voluntarily join this study; 5. Male patients with partners of childbearing potential must be surgically sterilized or agree to use effective contraception during the trial and for 3 weeks after the last administration of the study drug.
- interventionNames
- Drug: abiraterone acetate tablets (II)
- label
- Queue Two
- description
- 1. Age ≥18 years old; 2. Diagnosed with metastatic prostate cancer; 3. Previously used abiraterone acetate tablets continuously for more than 3 cycles; 4. At least one efficacy evaluation after medication.
Primary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available