Cross-Over Trial to Assess The Patient Preference for Goserelin Microsphere Versus Goserelin Implant in Patients With Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient preference
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients older than 18 years
- •Histologically confirmed prostate adenocarcinoma
- •Suitable for ADT treatment
- •Prior treatment without GnRH agonists
- •Expected survival >1 year
- •Good compliance
- •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
排除标准
- •Prior treatment with Zoladex, LY01005 or other GnRH agonists, while GnRH agonists for < 6 months and discontinued for more than 6 months were allowed
- •Diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions
- •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
- •Any medical conditions that the investigators believe make the patient ineligible to participate in the study
研究组 & 干预措施
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
干预措施: Zoladex (Drug)
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
干预措施: LY01005 (Drug)
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
干预措施: Zoladex (Drug)
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
干预措施: LY01005 (Drug)
结局指标
主要结局
Patient preference
时间窗: 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.
次要结局
未报告次要终点
研究者
Wang Xuegang
Associate chief physician
The First Affiliated Hospital of Xiamen University