PSMA-Positive Progressive Metastatic Castration-Resistant Prostate CancerPhase 3NCT07311694
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
A Phase 3 study testing HRS-4357 injection and Enzalutamide；Abiraterone in people with PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced 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
- PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
- What is being tested?
- HRS-4357 injection and Enzalutamide；Abiraterone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to Dec 2028
- Phase
- Phase 3
- 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
Who may be able to join
- Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;
- Male, aged ≥ 18 years;
- ECOG performance status score of 0-1;
- Expected survival time of no less than 6 months;
- Prostate adenocarcinoma confirmed by histology and/or cytology, and diagnosed as mCRPC (metastatic castration-resistant prostate cancer) with reference to current clinical guidelines;
- Presence of at least one metastatic lesion confirmed by imaging examinations (CT/MRI and/or bone scan) within 4 weeks before randomization;
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- Confirmation of at least one PSMA-positive lesion and no PSMA-negative lesions by PSMA PET/CT;
- Serum testosterone at castration level (< 50 ng/dl or < 1.7 nmol/L) at the screening visit; continuous luteinizing hormone-releasing hormone analog (LHRHA) therapy (medical castration) or previous bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must plan to maintain effective LHRHA therapy throughout the study period;
- Previous treatment with second-generation ARPIs, with only one episode of disease progression during treatment; and assessed by the investigator as suitable for switching to another ARPI (suitable for receiving abiraterone or enzalutamide);
- Disease progression at the time of enrollment. Disease progression is defined as the occurrence of at least one of the following while the subject's serum testosterone is at a stable castration level: ① PSA progression: PSA value > 1 ng/mL, with two consecutive increases in PSA at intervals of at least 1 week; ② Radiographic progression: occurrence of clearly new lesions; appearance of 2 or more new bone lesions on bone scan; lesion progression indicated by CT or MRI (per RECIST v1.1);
Who cannot join
- Received any of the following treatments before randomization:
- Any radionuclide therapy or hemi-body radiotherapy within 6 months.
- Any PSMA-targeted radiopharmaceutical therapy.
- Surgery, radiotherapy, or any local therapy within 4 weeks.
- Any other investigational drug intervention within 4 weeks.
- Known hypersensitivity to the components of the study drug or its analogs.
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- History of malignancy (other than prostate cancer) within 5 years before randomization that is expected to alter life expectancy or may interfere with disease assessment, excluding cured malignancies with low risk of metastasis and mortality (5-year survival rate > 90%), such as non-metastatic basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and low-grade superficial bladder cancer.
- Occurrence of severe infection (CTCAE > Grade 2) within 4 weeks before randomization.
- Failure to recover from adverse events of previous treatments (NCI-CTCAE Version 5.0 Grade > 1) before randomization, as judged by the investigator.
- Presence of poorly controlled clinical cardiac symptoms or cardiac diseases.
- History of physical or psychiatric illnesses/conditions that may interfere with the study objectives and assessments (including epilepsy and dementia).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Dingwei Ye
Shaoli Song
About this study
Official title: A Phase III, Randomized, Open-Label, Multicenter Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.
- Being tested
- HRS-4357 injection, Enzalutamide；Abiraterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4357 injectionDrug
HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles
Enzalutamide；AbirateroneDrug
ARPI (investigator's choice of any of the following agents, with the requirement that the agent has not been used previously):
- Enzalutamide 160 mg orally once daily (qd)
- Abiraterone 1000 mg orally once daily (qd) + Prednisone 5 mg orally twice daily (bid)
| Study group | Role | What they receive |
|---|---|---|
| HRS-4357 injection | Experimental | Not described Receives: Drug: HRS-4357 injection |
| Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate Tablets | Active comparator | Not described Receives: Drug: Enzalutamide；Abiraterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic progression-free survival (rPFS) assessed by the BIRC.
Measured: From Baseline to primary completion date, about 24 months
Secondary outcomes (11)
OS
Measured: From Baseline to primary completion date, about 24 months
rPFS（Investigator-Assessed）
Measured: From Baseline to primary completion date, about 24 months
ORR （Investigator-Assessed and BIRC-Assessed）
Measured: From Baseline to primary completion date, about 24 months
DCR（Investigator-Assessed and BIRC-Assessed）
Measured: From Baseline to primary completion date, about 24 months
DOR（Investigator-Assessed and BIRC-Assessed）
Measured: From Baseline to primary completion date, about 24 months
PSA50 Response Rate
Measured: From Baseline to primary completion date, about 24 months
Time to PSA Progression
Measured: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the EQ-5D-5L
Measured: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the Functional FACT-P
Measured: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the BPI-SF
Measured: From Baseline to primary completion date, about 24 months
Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: From Baseline to primary completion date, about 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start2 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSMA-Positive Progressive Metastatic Castration-Resistant Prostate CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
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
- NCT07311694
- Sponsor's protocol ID
- HRS-4357-301
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Open-Label, Multicenter Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07311694
- Acronym / sponsor ID
- HRS-4357-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Dec 2025 (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.
This study is a randomized, open-label, controlled, multicenter phase III clinical trial, which plans to randomly enroll 370 subjects with advanced metastatic castration-resistant prostate cancer (mCRPC). The efficacy of HRS-4357 versus novel androgen receptor pathway inhibitors (ARPI) in the treatment of PSMA-positive advanced metastatic castration-resistant prostate cancer (mCRPC) will be evaluated based on radiographic progression-free survival (rPFS) assessed by the BIRC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRS-4357 injection | Experimental | Drug: HRS-4357 injection |
| Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate Tablets | Active comparator | Drug: Enzalutamide；Abiraterone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing;
- Male, aged ≥ 18 years;
- ECOG performance status score of 0-1;
- Expected survival time of no less than 6 months;
- Prostate adenocarcinoma confirmed by histology and/or cytology, and diagnosed as mCRPC (metastatic castration-resistant prostate cancer) with reference to current clinical guidelines;
Key exclusion criteria (11 listed)
- Received any of the following treatments before randomization:
- Known hypersensitivity to the components of the study drug or its analogs.
- History of malignancy (other than prostate cancer) within 5 years before randomization that is expected to alter life expectancy or may interfere with disease assessment, excluding cured malignancies with low risk of metastasis and mortality (5-year survival rate > 90%), such as non-metastatic basal cell carcinoma of the skin, superficial squamous cell carcinoma of the skin, and low-grade superficial bladder cancer.
- Occurrence of severe infection (CTCAE > Grade 2) within 4 weeks before randomization.
- Failure to recover from adverse events of previous treatments (NCI-CTCAE Version 5.0 Grade > 1) before randomization, as judged by the investigator.
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 |
|---|---|---|
| HRS-4357 injectionHRS-4357 injection are administered each time, with dosing for 4 to 6 cycles | Drug | HRS-4357 injection |
| Enzalutamide；AbirateroneARPI (investigator's choice of any of the following agents, with the requirement that the agent has not been used previously): * Enzalutamide 160 mg orally once daily (qd) * Abiraterone 1000 mg orally once daily (qd) + Prednisone 5 mg orally twice daily (bid) | Drug | Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate Tablets |
Primary outcome
radiographic progression-free survival (rPFS) assessed by the BIRC.
Time frame: From Baseline to primary completion date, about 24 months
11 secondary outcomes
OS
Time frame: From Baseline to primary completion date, about 24 months
rPFS（Investigator-Assessed）
Time frame: From Baseline to primary completion date, about 24 months
ORR （Investigator-Assessed and BIRC-Assessed）
Time frame: From Baseline to primary completion date, about 24 months
DCR（Investigator-Assessed and BIRC-Assessed）
Time frame: From Baseline to primary completion date, about 24 months
DOR（Investigator-Assessed and BIRC-Assessed）
Time frame: From Baseline to primary completion date, about 24 months
PSA50 Response Rate
Time frame: From Baseline to primary completion date, about 24 months
Time to PSA Progression
Time frame: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the EQ-5D-5L
Time frame: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the Functional FACT-P
Time frame: From Baseline to primary completion date, about 24 months
Changes from baseline in scores of the BPI-SF
Time frame: From Baseline to primary completion date, about 24 months
Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From Baseline to primary completion date, about 24 months
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 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS-4357 injection and Enzalutamide；Abiraterone in people with PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer, 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 10 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 4 Feb 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yuezheng Ti (+0518-82342973, yuezheng.ti@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic progression-free survival (rPFS) assessed by the BIRC. (time frame: From Baseline to primary completion date, about 24 months). 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 4 Feb 2026.