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

NCT07721532 | Active Not Recruiting DMC FDA Drug

• 2 other identifiers: IUNU-PC-127Jiangsu Hengrui
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnosed With Metastatic Prostate Cancer

Keywords

abiraterone acetate tablets (II); prostate cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year

• OS

  1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year

• PSA

  1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year

Study Arms (2)

Queue One

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.

Drug: abiraterone acetate tablets (II)

Queue Two

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.

Interventions

abiraterone acetate tablets (II) DRUG

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.

Queue One

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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 Two: Patients with severely missing medical record data

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: July 23, 2026
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 21, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-03

Locations

CN (1)