Status:
COMPLETED
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.
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions:
Advanced Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
Evaluate the Safety, Efficacy and Pharmacokinetics of Leuprolide Injectable Emulsion in Advanced Prostate Cancer
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2024
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT06984159
Start Date
July 12 2022
End Date
April 24 2024
Last Update
May 22 2025
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000