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.

GeneScience Pharmaceuticals (GenSci)

Status and phase

Completed

Phase 3

Conditions

Advanced Prostate Cancer

Treatments

Drug: Leuprolide Injectable Emulsion (CAMCEVI®)

Study type

Interventional

Funder types

Industry

Identifiers

GenSci093-6M

Details and patient eligibility

About

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

Enrollment

137 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).