Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 2NCT04862091
Comparative Study of Abiraterone Acetate Tablets (I) or ZYTIGA® in Patients With Metastatic Castration-resistant Prostate Cancer
A Phase 2 study testing Abiraterone Acetate Tablets (I) and ZYTIGA® in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate whether the efficacy of the abiraterone acetate tablets (I) is comparable to that of the ZYTIGA®) by comparing the serum testosterone concentrations on Day 9 and/or Day 10 after oral administration of the two formulations in patients with metastatic castration-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer (mCRPC)
- What is being tested?
- Abiraterone Acetate Tablets (I) and ZYTIGA®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 23 Apr 2021to 6 Jan 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
Who may be able to join
- Males, ≥ 18 years old;
- Histologically or cytologically diagnosed with prostate adenocarcinoma, without neuroendocrine or small cell characteristics, and having metastatic lesions with imaging evidence (such as positive bone scan or metastatic lesions on CT/MRI);
- Serum testosterone level < 50 ng/dL or 1.7 nmol/L at the screening; subjects who have not undergone bilateral orchidectomy must plan to continue medication throughout the study to maintain therapy with effective GnRH agonist or antagonist;
- Progression of prostate cancer as confirmed by diagnostic files, meeting one of the conditions for disease progression: 1) Biochemistry evidence of recurrence: continuous 3 rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL, greater than 50% of the minimum value in 2 rises; 2) Radiographic progression: a clear evidence of new lesion; 2 or more new bone lesions appearing on bone scan; CT or MRI showing lesion progression (RECIST 1.1);
- ECOG performance status score of ≤ 1;
- Life expectancy of ≥ 6 months;
- Major organs are functioning well
Who cannot join
- History of pituitary or adrenal dysfunction;
- Have used flutamide within 4 weeks before the first dose of study treatment, and bicalutamide or nilutamide within 6 weeks before the first dose of study treatment;
- Prior therapy with CYP17 inhibitors (such as abiraterone acetate, ketoconazole, TAK-700, etc.) or investigational drugs or marketed drugs of new androgen receptor antagonists (such as enzalutamide, apalutamide, SHR3680, ODM-201, and proxalutamide);
- Have received 5-reductase inhibitors (such as finasteride and dutasteride), estrogen, progesterone, any herbal products (such as saw palmetto) that may decrease PSA levels, and radiotherapy within 4 weeks prior to the start of study medication;
- Have previously received biotherapy or cytotoxic chemotherapy for mCRPC; patients who have completed docetaxel treatment for at least 1 year before enrollment can participate in screening;
- Prostate cancer with moderate to severe pain symptoms, with a score of > 3 for Question 3 (the worst pain in the last 24 hours, 0-1 point means asymptomatic, 2-3 points mean mild symptoms) of the Brief Pain Inventory-Short Form (BPI-SF);
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- With contraindications to the use of glucocorticoids, such as uncontrolled persistent infections or other conditions;
- Chronic diseases that require systemic corticosteroid therapy (> 10 mg/day prednisone or equivalent). Patients who have discontinued the administration or reduced the dose to < 10 mg within 14 days prior to the start of study treatment are eligible;
- Presence of abdominal fistula, gastrointestinal perforation, abdominal abscess, or other abnormal gastrointestinal function within 6 months before the first dose of study treatment, which may affect drug absorption as judged by the investigator;
- Presence of active heart disease within 6 months prior to the first dose of study treatment, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, left ventricular ejection fraction < 50%, and severe arrhythmia requiring treatment or New York Heart Association (NYHA) Class III-IV heart failure;
- Inability to swallow the whole tablet;
- Other conditions that make the patient unsuitable for the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Randomized, Open-Label, Multi-Center, Parallel Controlled Study Comparing the Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer After Oral Administration of Abiraterone Acetate Tablets (I) or ZYTIGA®
To evaluate whether the efficacy of the abiraterone acetate tablets (I) is comparable to that of the ZYTIGA®) by comparing the serum testosterone concentrations on Day 9 and/or Day 10 after oral administration of the two formulations in patients with metastatic castration-resistant prostate cancer (mCRPC).
- Being tested
- Abiraterone Acetate Tablets (I), ZYTIGA®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abiraterone Acetate Tablets (I)Drug
Abiraterone Acetate Tablets (I)
ZYTIGA®Drug
ZYTIGA®
| Study group | Role | What they receive |
|---|---|---|
| Abiraterone Acetate Tablets (I) | Experimental | Not described Receives: Drug: Abiraterone Acetate Tablets (I) |
| ZYTIGA®. | Active comparator | Not described Receives: Drug: ZYTIGA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum testosterone concentration
Blood Sample tested for Serum Testosterone Levels
Measured: Day 9/Day 10
Secondary outcomes (9)
PSA level
The serum total PSA level
Measured: Day 28, Day 56, and Day 84
PSA-50 response rate
The percentage of subjects with total serum PSA level decreased by 50% from the baseline value.
Measured: Day 28, Day 56, and Day 84
Absolute testosterone concentration
The actual measured serum testosterone concentration.
Measured: Day 9/10, Day 28, Day 56, and Day 84
Testosterone inhibition rate
The percentage of subjects with a serum testosterone concentration of ≤ 1 ng/dL
Measured: Day 9/10, Day 28, Day 56, and Day 84
Steady-state minimum concentration of abiraterone
Defined as the plasma concentration of abiraterone
Measured: Day 9/10, Day 28, Day 56, and Day 84
Cmax, ss
Defined as the steady-state maximum concentration
Measured: Day 9
AUC0-τ
Defined as the area under the curve within the dosing interval at steady state
Measured: Day 9
Cmin, ss
Defined as the steady-state minimum concentration
Measured: Day 9
Cav, ss
Defined as the mean blood drug concentration during the dosing interval at steady state
Measured: Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start23 Apr 2021
- Primary completion21 Oct 2021
- Study completion6 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Abiraterone Acetate Tablets (I) compared with ZYTIGA®
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862091
- Sponsor's protocol ID
- ABTL-PD-01
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lu X, Dai T, Chen X, Wu B, Chen H, Wu J, Yu D, Ge H, Li J, Huang H, Fan T, Cheng L, Zhang X, Zhang X, Yao X, Wei J, Xu Z, Yang W, He C, Luo J, Guan L, Fu B, Wang Q, Chen X, Zhang Y, Shi B, Zheng B, Wang Y, Luo H, Chen G, Wang H, Wang Q, Ye D. A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer. BMC Med. 2025 May 9;23(1):271. doi: 10.1186/s12916-025-04053-7.
PubMed 40346626
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multi-Center, Parallel Controlled Study Comparing the Serum Testosterone Levels in Patients With Metastatic Castration-Resistant Prostate Cancer After Oral Administration of Abiraterone Acetate Tablets (I) or ZYTIGA®
- ClinicalTrials.gov ID
- NCT04862091
- Acronym / sponsor ID
- ABTL-PD-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 27 Apr 2021 (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.
To evaluate whether the efficacy of the abiraterone acetate tablets (I) is comparable to that of the ZYTIGA®) by comparing the serum testosterone concentrations on Day 9 and/or Day 10 after oral administration of the two formulations in patients with metastatic castration-resistant prostate cancer (mCRPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Abiraterone Acetate Tablets (I) compared with ZYTIGA®
| Arm | Type | Receives |
|---|---|---|
| Abiraterone Acetate Tablets (I) | Experimental | Drug: Abiraterone Acetate Tablets (I) |
| ZYTIGA®. | Active comparator | Drug: ZYTIGA® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males, ≥ 18 years old;
- Histologically or cytologically diagnosed with prostate adenocarcinoma, without neuroendocrine or small cell characteristics, and having metastatic lesions with imaging evidence (such as positive bone scan or metastatic lesions on CT/MRI);
- Serum testosterone level < 50 ng/dL or 1.7 nmol/L at the screening; subjects who have not undergone bilateral orchidectomy must plan to continue medication throughout the study to maintain therapy with effective GnRH agonist or antagonist;
- Progression of prostate cancer as confirmed by diagnostic files, meeting one of the conditions for disease progression: 1) Biochemistry evidence of recurrence: continuous 3 rises of PSA (taken a minimum of 1 week apart) from a baseline measurement of at least 2 ng/mL, greater than 50% of the minimum value in 2 rises; 2) Radiographic progression: a clear evidence of new lesion; 2 or more new bone lesions appearing on bone scan; CT or MRI showing lesion progression (RECIST 1.1);
- ECOG performance status score of ≤ 1;
Key exclusion criteria (12 listed)
- History of pituitary or adrenal dysfunction;
- Have used flutamide within 4 weeks before the first dose of study treatment, and bicalutamide or nilutamide within 6 weeks before the first dose of study treatment;
- Prior therapy with CYP17 inhibitors (such as abiraterone acetate, ketoconazole, TAK-700, etc.) or investigational drugs or marketed drugs of new androgen receptor antagonists (such as enzalutamide, apalutamide, SHR3680, ODM-201, and proxalutamide);
- Have received 5-reductase inhibitors (such as finasteride and dutasteride), estrogen, progesterone, any herbal products (such as saw palmetto) that may decrease PSA levels, and radiotherapy within 4 weeks prior to the start of study medication;
- Have previously received biotherapy or cytotoxic chemotherapy for mCRPC; patients who have completed docetaxel treatment for at least 1 year before enrollment can participate in screening;
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 (I)Abiraterone Acetate Tablets (I) | Drug | Abiraterone Acetate Tablets (I) |
| ZYTIGA®ZYTIGA® | Drug | ZYTIGA®. |
Primary outcome
Serum testosterone concentration
Time frame: Day 9/Day 10
Blood Sample tested for Serum Testosterone Levels
9 secondary outcomes
PSA level
Time frame: Day 28, Day 56, and Day 84
PSA-50 response rate
Time frame: Day 28, Day 56, and Day 84
Absolute testosterone concentration
Time frame: Day 9/10, Day 28, Day 56, and Day 84
Testosterone inhibition rate
Time frame: Day 9/10, Day 28, Day 56, and Day 84
Steady-state minimum concentration of abiraterone
Time frame: Day 9/10, Day 28, Day 56, and Day 84
Cmax, ss
Time frame: Day 9
AUC0-τ
Time frame: Day 9
Cmin, ss
Time frame: Day 9
Cav, ss
Time frame: Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 40346626Lu X, Dai T, Chen X, Wu B, Chen H, Wu J, Yu D, Ge H, Li J, Huang H, Fan T, Cheng L, Zhang X, Zhang X, Yao X, Wei J, Xu Z, Yang W, He C, Luo J, Guan L, Fu B, Wang Q, Chen X, Zhang Y, Shi B, Zheng B, Wang Y, Luo H, Chen G, Wang H, Wang Q, Ye D. A randomized, open-label, multi-center, active-controlled phase II study comparing abiraterone acetate tablets (II), an improved formulation, versus originator abiraterone acetate in patients with metastatic castration-resistant prostate cancer. BMC Med. 2025 May 9;23(1):271. doi: 10.1186/s12916-025-04053-7.
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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?
A Phase 2 study testing Abiraterone Acetate Tablets (I) and ZYTIGA® in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Jiangsu HengRui Medicine Co., Ltd. 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 12 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: finished, as of the sponsor's last update on 4 Mar 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum testosterone concentration (time frame: Day 9/Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862091, which also lists 1 linked publication.
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 4 Mar 2022.