A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

Inclusion Criteria:

1. Males aged ≥18 years at screening and voluntary to participate in the study and signthe informed consent form.

2. Subjects with histologically or cytologically confirmed prostate adenocarcinoma,with no small cell features.

3. In the case of medical or surgical castration, during or after the last treatmentbefore screening, there are signs of progressive disease determined according to thePCWG3 criteria, defined as satisfying one or more of the following 3 criteria:

4. PSA progression; at least 2 episodes of increased PSA levels that are measured ≥1 week apart; PSA ≥ 1 μg/L (1 ng/mL) in the screening period;

5. Progression of soft tissue lesions as defined by RECIST 1.1;

6. The progression of bone lesions is defined as at least two new lesionsdiscovered by bone scan; ambiguous results can be confirmed using anotherimaging technique (e.g., CT or MRI).

7. Metastatic diseases confirmed by imaging examinations during the screening period (the status of metastasis refers to the presence of metastatic lesions confirmed bybone scan and/or CT/MRI scan).

8. For patients who have undergone orchiectomy or are being treated by medicalcastration therapy, their androgen blockade therapy is maintained by luteinizinghormone-releasing hormone agonists or antagonists during the study period (includingthe follow-up period), and their serum testosterone levels are ≤ 1.73 nmol/L (50ng/dL) during screening visits.

9. Patients who have failed previous treatments of prostate cancer with abirateroneacetate or who are intolerant to treatments with abiraterone acetate.

10. Patients who have failed previous chemotherapy of prostate cancer with docetaxel orwho are intolerant to treatments with docetaxel, or who are not suitable fordocetaxel treatment during screening. Patients who are not suitable for docetaxeltreatment during screening and do not plan to use cytotoxic chemotherapy within 6months after the informed discussion are eligible.

11. Expected survival of ≥ 3 months.

12. ECOG performance status score of 0-2.

13. Laboratory tests must meet the following criteria:

14. Blood routine examination: Hemoglobin (Hb) ≥ 85 g/L; white blood cell (WBC) ≥ 3.0 x 109/L; platelet (PLT) ≥ 75 x 109/L;

15. Liver function: Total bilirubin (TBIL) ≤ 1.5 x ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (for patients withoutliver metastasis) or ≤ 5 x ULN (for patients with liver metastasis); albumin (ALB) ≥ 25 g/L;

16. Renal function: serum creatinine (SCr) ≤ 1.5 x ULN.

17. Willing to use reliable contraceptive measures (such as condoms) and not to donatesperms throughout the study period and within 3 months after the last dose.

Exclusion Criteria:

Subjects with any of the following conditions should not be enrolled:

1. Received any anti-prostate cancer treatment within 4 weeks before randomization,including chemotherapy, immunotherapy, targeted therapy, estrogen therapy,anti-androgen therapy, systemic radiotherapy, treatments with traditional Chinesemedicines for anticancer, or treatments with interventional drugs of other clinicaltrials; palliative radiotherapy or surgery for bone metastatic or soft tissuelesions should be completed >14 days prior to baseline imaging examinations; thelesions treated by palliative radiotherapy should not be the targeted lesions ofsubsequent RECIST 1.1 assessment. Androgen blockade therapy that is maintained by aluteinizing hormone releasing hormone agonist or antagonist.

2. Previously received any of novel androgen receptor inhibitors (e.g., Enzalutamide,Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119).

3. Patients with brain or central nervous system metastases are known (if a brain orcentral nervous system metastasis is suspected, a CT/MRI scan of the head isrequired)

4. Patients with known serious cardiovascular diseases, including any of the following:

5. A myocardial infarction or thrombotic event occurred in the past 6 months;

6. Known unstable angina;

7. Heart failure of Grade III or IV according to the New York Heart Association (NYHA) criteria;

8. QT interval of > 500 ms during screening visits;

9. Resting systolic blood pressure of >170 mmHg or diastolic blood pressure of >105 mmHg suggesting uncontrolled hypertension during screening visits.

10. The toxicity of previous treatment has not been eliminated before the start of thestudy treatment; toxic reaction of grade 2 or above (except for hair loss) accordingto the CTCAE 5.0 grading scale remains.

11. Clinically significant gastrointestinal abnormalities that may affect the intake,transport or absorption of drugs (for example, inability to swallow, chronicdiarrhea or intestinal obstruction, and patients had total gastrectomy).

12. Patients with a history of serious diseases in the central nervous system. Patientswith a history of epilepsy or any history of diseases that may induce epilepsy,including unexplained loss of consciousness or transient ischemic attack.

13. Patients who have been diagnosed in the past 5 years with other malignant tumors inaddition to prostate cancer, except patients with cured basal or squamous cell skincancer and superficial bladder tumors (Ta, Tis, and T1).

14. Patients with a history of allogeneic bone marrow or organ transplantation whorequire continued medical treatment.

15. Patients with known congenital or acquired immunodeficiency, active hepatitis,active tuberculosis or other active infections.

16. Patients known to be allergic to androgen receptor inhibitors.

17. The investigator believes that the patients are unfit for this study (e.g., thetreatments will not benefit the patients the most, inadequate patient compliance,etc.).