Actively Recruiting
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-02-04
370
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate, understand study procedures, and able to sign informed consent
- Male, aged 18 years or older
- ECOG performance status of 0-1
- Expected survival of at least 6 months
- Prostate adenocarcinoma confirmed by histology or cytology with diagnosis of metastatic castration-resistant prostate cancer
- At least one metastatic lesion confirmed by recent imaging (CT, MRI, or bone scan)
- At least one PSMA-positive lesion and no PSMA-negative lesions confirmed by PSMA PET/CT
- Serum testosterone at castration level (< 50 ng/dl or < 1.7 nmol/L) with ongoing hormone therapy or prior orchiectomy
- Previous treatment with second-generation androgen receptor pathway inhibitors with only one progression episode, suitable for switching to another ARPI
- Evidence of disease progression defined by rising PSA or new lesions on imaging while maintaining castration-level testosterone
You will not qualify if you...
- Received radionuclide therapy or hemi-body radiotherapy within 6 months before randomization
- Received PSMA-targeted radiopharmaceutical therapy
- Had surgery, radiotherapy, or local therapy within 4 weeks before randomization
- Received other investigational drug treatments within 4 weeks before randomization
- Known allergy to study drug components or similar agents
- History of other malignancies within 5 years expected to affect life expectancy or disease assessment, except certain low-risk skin and bladder cancers
- Severe infection within 4 weeks before randomization
- Unresolved adverse events from previous treatments graded above 1
- Poorly controlled cardiac symptoms or diseases
- Physical or psychiatric conditions interfering with study objectives, including epilepsy and dementia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
Research Team
Y
Yuezheng Ti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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