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NCT Number: NCT07721532

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Diagnosed With Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Nanjing Drum Tower Hospital

Nanjing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

abiraterone acetate tablets (II)

Drug
  • 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.

Primary outcomes

  1. SAE

    Time frame: 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

  2. TEAE

    Time frame: 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 outcomes

  1. DOT

    Time frame: 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);

  2. rPFS

    Time frame: 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

  3. OS

    Time frame: 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

  4. PSA

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Collaborators

  • Jiangsu Hengrui Pharmaceutical Co., Ltd.
  • Northern Jiangsu People's Hospital

Registry information

Acronym: prostate

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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