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

NCT07721532 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2026-07-23

No results posted yet for this study

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

Interventions

DRUG

abiraterone 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 & Collaborators

  • Jiangsu Hengrui Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Northern Jiangsu People's Hospital

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2027-12-21
Completion
2027-12-21
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721532 on ClinicalTrials.gov