Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385847
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-24
Brief Title:
To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
Sponsor:
The First Affiliated Hospital of Xiamen University
Organization:
The First Affiliated Hospital of Xiamen University
Study Overview
Official Title:
Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The GOMIMP will be a Prospective Randomized Cross-over Trial to Explore the Patient Preference for Goserelin Microsphere Zoladex Versus Goserelin Implant LY01005 in Patients of Prostate Cancer
Detailed Description:
Androgen Deprivation Therapy ADT is an important systemic therapy for prostate cancer which plays a vital role in the treatment of various stages of prostate cancer Gonadotropin-releasing hormone GnRH agonists are the most commonly used ADT treatmentincluding leuprolide goserelin and triptorelin The goserelin implant Zoladex 36 mg is administered subcutaneously every 28 days into the anterior abdominal wall using a pre-filled syringe with a 16G needle outer diameter 16 mm while the Goserelin microsphere LY01005 36 mg is administered every 28 days by intramuscular injection using a 21G injection needle outer diameter 08 mm Phase III study NCT04563936 have confirmed the similar efficacy and safety between the two drugs but patient preference for both are unknown
The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer
The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None