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.

NCT ID: NCT06984159

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2024-04-24

Brief Summary

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

Conditions

Advanced Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leuprolide Injectable Emulsion

Group Type: EXPERIMENTAL

Leuprolide Injectable Emulsion (CAMCEVI®)

Intervention Type: DRUG

Leuprolide Injectable Emulsion (CAMCEVI®)，Subcutaneous injection，Once every 24 weeks for a total of 2 doses

Interventions

Leuprolide Injectable Emulsion (CAMCEVI®)

Leuprolide Injectable Emulsion (CAMCEVI®)，Subcutaneous injection，Once every 24 weeks for a total of 2 doses

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

GenSci093-6M

Identifier Type: -

Identifier Source: org_study_id