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.

NCT06984159 | Completed Phase 3

• 1 other identifier: GenSci093-6M
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Cumulative probability of maintaining serum testosterone at a castrate level (≤ 50 ng/dL) from the end of 28 days after the first dose to the end of 168 days after the second dose.

  To evaluate the castrate level maintenance of Leuprolide Injectable Emulsion from the end of 28 days after the first dose to the end of 168 days after the second dose, with serum testosterone as a surrogate parameter for the assessment of efficacy and a castrate level of 50 ng/dL.

  from the end of 28 days after the first dose to the end of 168 days after the second dose.

• including but not limited to:adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), injection site reactions, local tolerance, etc.

  To evaluate the safety and tolerability of Leuprolide Injectable Emulsion after two subcutaneous injections in patients with advanced prostate cancer.

  336 days

Study Arms (1)

Leuprolide Injectable Emulsion

EXPERIMENTAL

Drug: Leuprolide Injectable Emulsion (CAMCEVI®)

Interventions

Leuprolide Injectable Emulsion (CAMCEVI®) DRUG

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

Leuprolide Injectable Emulsion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 22, 2025
• Study Start: July 12, 2022
• Primary Completion: November 30, 2023
• Study Completion: April 24, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (1)