A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT07311694
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
370 participants
INTERVENTIONAL
2026-01-31
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HRS-4357 injection
HRS-4357 injection
HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles
Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate Tablets
Enzalutamide；Abiraterone
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)
Interventions
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HRS-4357 injection
HRS-4357 injection are administered each time, with dosing for 4 to 6 cycles
Enzalutamide；Abiraterone
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)
Eligibility Criteria
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Inclusion Criteria
2. Male, aged ≥ 18 years;
3. ECOG performance status score of 0-1;
4. Expected survival time of no less than 6 months;
5. Prostate adenocarcinoma confirmed by histology and/or cytology, and diagnosed as mCRPC (metastatic castration-resistant prostate cancer) with reference to current clinical guidelines;
6. Presence of at least one metastatic lesion confirmed by imaging examinations (CT/MRI and/or bone scan) within 4 weeks before randomization;
7. Confirmation of at least one PSMA-positive lesion and no PSMA-negative lesions by PSMA PET/CT;
8. 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;
9. 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);
10. 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);
Exclusion Criteria
1. Any radionuclide therapy or hemi-body radiotherapy within 6 months.
2. Any PSMA-targeted radiopharmaceutical therapy.
3. Surgery, radiotherapy, or any local therapy within 4 weeks.
4. Any other investigational drug intervention within 4 weeks.
2. Known hypersensitivity to the components of the study drug or its analogs.
3. 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.
4. Occurrence of severe infection (CTCAE \> Grade 2) within 4 weeks before randomization.
5. Failure to recover from adverse events of previous treatments (NCI-CTCAE Version 5.0 Grade \> 1) before randomization, as judged by the investigator.
6. Presence of poorly controlled clinical cardiac symptoms or cardiac diseases.
7. History of physical or psychiatric illnesses/conditions that may interfere with the study objectives and assessments (including epilepsy and dementia).
18 Years
MALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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HRS-4357-301
Identifier Type: -
Identifier Source: org_study_id