Prostate Cancer
Conditions
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 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.
Interventions
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, randomized, open-label, cross-over phase II trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient preference | Assessed up 16 weeks after randomization | Patient preference (assessed by a single question) between Zoladex and LY01005 after completion of the second period of treatment. |
Countries
China
Contacts
Primary ContactXuegang Wang, doctor
Outcome results
None listed