Diagnosed With Metastatic Prostate Cancer
Conditions
Keywords
abiraterone acetate tablets (II), prostate cancer
Brief 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.
Interventions
DRUGabiraterone acetate tablets (II)
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Northern Jiangsu People's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAE | 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year | Serious adverse event |
| TEAE | 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year | Adverse events caused by treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DOT | 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year | Compliance indicators: duration of medication (DOT); |
| rPFS | 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year | Relapse-Free Survival |
| OS | 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year | overall survival |
| PSA | 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year | PSA response rate |
Countries
China
Outcome results
None listed