Clinical trial NCT06385847: To Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
Official title: Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, randomized, open-label, cross-over phase II trial
Primary purpose: OTHER

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.

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 \</=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

Primary outcomes:
measure: Patient preference
timeFrame: Assessed up 16 weeks after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References: