To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
NCT ID: NCT06385847
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-05-31
2025-12-31
Brief Summary
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Detailed Description
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The objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Zo-LY
Arm Zo-LY: Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles, followed by LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles
Zoladex
Patients received 3.6 mg subcutaneous Zoladex
LY01005
Patients received 3.6 mg intramuscular LY01005
LY-Zo
Arm LY-Zo: LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles, followed by Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles
Zoladex
Patients received 3.6 mg subcutaneous Zoladex
LY01005
Patients received 3.6 mg intramuscular LY01005
Interventions
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Zoladex
Patients received 3.6 mg subcutaneous Zoladex
LY01005
Patients received 3.6 mg intramuscular LY01005
Eligibility Criteria
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Inclusion Criteria
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 \</=1.5 x ULN;
* Total bilirubin \</=1.5 x ULN,
* Serum creatinine \</=1.5 x ULN. If creatinine 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60 mL/min should be excluded
Exclusion Criteria
2. Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions
3. A history of cardiovascular events, uncontrolled hypertension, gastrointestinal disease that interferes with treatment absorption, active viral hepatitis, or human immunodeficiency infection (HIV) within the past 6 months
4. Any medical conditions that the investigators believe make the patient ineligible to participate in the study
18 Years
MALE
No
Sponsors
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The First Affiliated Hospital of Xiamen University
OTHER
Responsible Party
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Wang Xuegang
Associate chief physician
Locations
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GOMIMP
Identifier Type: -
Identifier Source: org_study_id
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