The Study Will Evaluate if Leuprolide Mesylate is Safe and Effective in the Treatment of Subjects With Advanced Prostate Carcinoma, When Administered as Two Injections Six Months Apart.

An Open-Label, Single-Arm, Multicenter Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Leuprolide Injectable Emulsion in Advanced Prostate Cancer

Evaluate the Safety, Efficacy and Pharmacokinetics of Leuprolide Injectable Emulsion in Advanced Prostate Cancer

Inclusion Criteria:

• After having the scope and nature of the study explained, subjects must voluntarily sign the ICF prior to the screening visit and be willing to comply with the study requirements and cooperate with all scheduled tests
• Male, aged ≥ 18 years old.
• Pathologically confirmed advanced prostate cancer candidate for Androgen Deprivation Therapy, including patients those who have undergone radical treatment (surgical resection, external radiotherapy, or cryotherapy).

Exclusion Criteria:

• Received or are undergoing Androgen Deprivation Therapy (surgical castration or drug Androgen Deprivation Therapy including but not limited to gonadotropin-releasing hormone [GnRH] receptor agonists, GnRH receptor antagonists, estrogen and progesterone and their analogs, androgen receptor antagonists, androgen synthesis inhibitors, etc.).
• Major surgery (including but not limited to radical prostatectomy, etc.), radiotherapy, chemotherapy, immunotherapy, cryotherapy, etc. within 4 weeks prior to the screening visit, or plan to receive the above treatments during the study
• Receipt of any vaccination within 4 weeks prior to first dose (except COVID-19 vaccination).