New hope for tough prostate cancer: HRS-4357 faces off against standard care in major trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be willing to participate in this clinical trial, understand the study procedures, and be able to sign the informed consent form in writing; 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. Received any of the following treatments before randomization: 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).