A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

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;

Exclusion criteria