Google Maps

NCT07721532

Overview

NCT ID: NCT07721532
Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolOTHER
Official Title: Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic 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.

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Jan 8, 2025Actual
Primary Completion Date: Dec 21, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Observational
Phase: No data available
Enrollment: 3,000Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: Nanjing Drum Tower Hospital

Similar Studies

Participant Group/Arms

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.