Prostate Cancer Clinical Trials

• Patients must have the ability to understand and sign an approved informed consent form (ICF).

• Age at the time of consent ≥ 18 years;

• Life expectancy of ≥ 3 months;

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;

• Prostate adenocarcinoma confirmed by histological or cytological examination, except neuroendocrine carcinoma or small cell carcinoma;

• Metastatic prostate cancer disease, documented by CT/MRI imaging/bone scan ;

• Ongoing luteinizing hormone-releasing hormone agonist (LHRHa) or antagonist therapy (medical castration) or prior bilateral orchiectomy (surgical castration); subjects who have not undergone bilateral orchiectomy must be scheduled for Maintain effective LHRHa therapy throughout the study period;

• Testosterone at castration level (≤50ng/dL or 1.7nmol/L) at screening;

• Progressive disease in the setting of medical or surgical castration for study entry, the subject has 1 or more of the following 3 items: (1) PSA progression, defined as PSA \> 1ng/ml and at least 2 episodes of PSA level elevation ≥ 1 week apart; (2) disease progression as defined by RECIST 1.1; (3) bone disease progression as defined by PCWG3 criteria, i.e., ≥ more than 2 new lesions found on bone scan;

• Previous anti-tumor therapy meet the following conditions： Ib and IIb: Failure of previous abiraterone acetate therapy (refers to disease progression during abiraterone acetate treatment; disease progression is defined as the same as in Article 9 of the enrollment criteria), and no next generation androgen receptor inhibitors (enzalutamide or apalutamide, etc.) have been used; IIb: Failure of previous only one approved novel hormone therapy, such as abiraterone acetate, apalutamide, darolutamide and rezvilutamide, etc., except enzalutamide；

• Adequate hematologic and non-hematologic function during the screening.

• Must agree to take adequate contraceptive measures from the beginning of the study to at least 3 months after the last dose of the test drug, and prohibit sperm donation;

• Ability to comply with all procedures of the clinical trial protocol.