NCT07311694
Recruiting
Phase 3
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
Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country370 target enrollmentStarted: February 2, 2026Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- radiographic progression-free survival (rPFS) assessed by the BIRC.
Overview
Brief 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). 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
- •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);
Exclusion Criteria
- •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.
- •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.
Arms & Interventions
HRS-4357 injection
Experimental
Intervention: HRS-4357 injection (Drug)
Enzalutamide Soft Capsules / Abiraterone Acetate Tablets+ Prednisone Acetate Tablets
Active Comparator
Intervention: Enzalutamide；Abiraterone (Drug)
Outcomes
Primary Outcomes
radiographic progression-free survival (rPFS) assessed by the BIRC.
Time Frame: From Baseline to primary completion date, about 24 months
Secondary Outcomes
- OS(From Baseline to primary completion date, about 24 months)
- rPFS（Investigator-Assessed）(From Baseline to primary completion date, about 24 months)
- ORR （Investigator-Assessed and BIRC-Assessed）(From Baseline to primary completion date, about 24 months)
- DCR（Investigator-Assessed and BIRC-Assessed）(From Baseline to primary completion date, about 24 months)
- DOR（Investigator-Assessed and BIRC-Assessed）(From Baseline to primary completion date, about 24 months)
- PSA50 Response Rate(From Baseline to primary completion date, about 24 months)
- Time to PSA Progression(From Baseline to primary completion date, about 24 months)
- Changes from baseline in scores of the EQ-5D-5L(From Baseline to primary completion date, about 24 months)
- Changes from baseline in scores of the Functional FACT-P(From Baseline to primary completion date, about 24 months)
- Changes from baseline in scores of the BPI-SF(From Baseline to primary completion date, about 24 months)
- Assessment of the incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(From Baseline to primary completion date, about 24 months)
Investigators
Study Sites (1)
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