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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diagnosed With Metastatic Prostate Cancer
• Intervention / Treatment: Drug: abiraterone acetate tablets (II)

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• China
  • Nanjing, China
    • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

• Diagnosed with metastatic prostate cancer
• Researchers assess eligibility to use abiraterone acetate tablets (II) for treatment, or previous use, or ongoing treatment with abiraterone acetate tablets (II)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Queue One; Age ≥ 18 years old;; Diagnosed with metastatic prostate cancer;; 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;; Sign the informed consent and voluntarily join this study;; 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.	Drug: abiraterone acetate tablets (II); Age ≥ 18 years old;; Diagnosed with metastatic prostate cancer;; 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;; Sign the informed consent and voluntarily join this study;; 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.
Queue Two; Age ≥18 years old;; Diagnosed with metastatic prostate cancer;; Previously used abiraterone acetate tablets continuously for more than 3 cycles;; At least one efficacy evaluation after medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE	Serious adverse event	1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
TEAE	Adverse events caused by treatment	1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DOT	Compliance indicators: duration of medication (DOT);	1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
rPFS	Relapse-Free Survival	1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
OS	overall survival	1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
PSA	PSA response rate	1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.; Northern Jiangsu People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2025
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 21, 2027

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer; abiraterone acetate tablets (II)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Androstenes; Androstanes; Abiraterone Acetate
• Other Study ID Numbers: IUNU-PC-127; Jiangsu Hengrui (Other Grant/Funding Number: Jiangsu Hengrui Pharmaceuticals Co., Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No