Clinical trial · Interventional
To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
NCT06385847CI-TRIAL-00076543unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LY01005 | Drug | — | UNRESOLVED |
| Zoladex | Drug | Goserelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Zo-LY
- description
- Arm Zo-LY: Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles, followed by LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles
- interventionNames
- Drug: Zoladex
- Drug: LY01005
- type
- OTHER
- label
- LY-Zo
- description
- Arm LY-Zo: LY01005 3.6 mg (i.m.)/4W ✖ 2 cycles, followed by Zoladex 3.6 mg (s.c.)/4W ✖ 2 cycles
- interventionNames
- Drug: Zoladex
- Drug: LY01005
Primary outcomes (1)
- measure
- Patient preference
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 \</=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: 1. Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for \< 6 months and discontinued for more than 6 months were allowed 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
References
Publications (0)
Data not yet available
No reference posted for this study.