Diagnosed With Metastatic Prostate CancerprostateNCT07721532
Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
An observational study of Diagnosed With Metastatic Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diagnosed With Metastatic Prostate Cancer
- What is being tested?
- abiraterone acetate tablets (II)
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to 21 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- abiraterone acetate tablets (II)
- Keywords
- abiraterone acetate tablets (II), prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAE
Serious adverse event
Measured: 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
Measured: 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
Compliance indicators: duration of medication (DOT);
Measured: 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
Measured: 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
Measured: 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
Measured: 1.Baseline period 2.Once every three months during the first year after enrollment 3.Check every six months in the second year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start8 Jan 2025
- Primary completion21 Dec 2027 (estimated)
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnosed With Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd., Northern Jiangsu People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721532
- Sponsor's protocol ID
- IUNU-PC-127
- Other IDs
- Jiangsu Hengrui
- Acronym
- prostate
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07721532
- Acronym / sponsor ID
- prostate / IUNU-PC-127
- Keywords
- abiraterone acetate tablets (II), prostate cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd., Northern Jiangsu People's Hospital
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 21 Dec 2027 (estimated)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Queue One | – | 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Queue One |
Primary outcome
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
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
4 secondary outcomes
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosed With Metastatic Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.