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Trial Title:
To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
NCT ID:
NCT06385847
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Goserelin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
Prospective, randomized, open-label, cross-over phase II trial
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Zoladex
Description:
Patients received 3.6 mg subcutaneous Zoladex
Arm group label:
LY-Zo
Arm group label:
Zo-LY
Intervention type:
Drug
Intervention name:
LY01005
Description:
Patients received 3.6 mg intramuscular LY01005
Arm group label:
LY-Zo
Arm group label:
Zo-LY
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
treatment，including leuprolide, goserelin, and triptorelin. The goserelin implant
(Zoladex®) 3.6 mg is administered subcutaneously every 28 days into the anterior
abdominal wall using a pre-filled syringe with a 16G needle (outer diameter 1.6 mm),
while the Goserelin microsphere (LY01005) 3.6 mg is administered every 28 days by
intramuscular injection using a 21G injection needle (outer diameter 0.8 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male patients older than 18 years
2. Histologically confirmed prostate adenocarcinoma
3. Suitable for ADT treatment
4. ECOG≤2
5. Prior treatment without GnRH agonists
6. Expected survival >1 year
7. Good compliance
8. Adequate organ or bone marrow function as evidenced by:
- Hemoglobin >/= 10 g/dL
- Absolute neutrophil count >/=1.5 x 109/L,
- Platelet count >/=100 x 109/L,
- AST/SGOT and/or ALT/SGPT
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuegang Wang, doctor
Phone:
15960263909
Email:
stefwxg@163.com
Start date:
May 2024
Completion date:
December 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06385847
