NCT06490328已完成3 期
A Phase 3, Multi-center, Single-group, Open-label Study to Evaluate the Efficacy and Safety of DKF-MA102 in Patients With Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 8
- 主要终点
- Percentage of participants
研究概览
简要总结
A phase 3, multi-center, single-group, open-label study to evaluate the efficacy and safety of DKF-MA102 in patients with prostate cancer.
详细描述
This study is conducted to confirm the pharmacodynamic effects, efficacy, and safety of DKF-MA102 in prostate cancer patients by measuring the changes in serum testosterone levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male aged 19 or older
- •Histologically or cytologically-confirmed prostate cancer
- •Serum testosterone level >150 ng/dL
- •ECOG PS grade ≤ 2
- •Life expectancy of at least 1 year
排除标准
- •History of surgical procedures such as testicular resection, adrenal resection, and pituitary resection
- •History of hormone therapy
- •History of 5α-reductase inhibitor
- •History of radical radiation therapy
- •History of adjuvant male hormone block therapy
- •Severe liver failure
- •Serum creatinine ≥1.5 times the ULN
- •Hormone-independent prostate cancer
- •Diagnosed pituitary adenoma
- •Brain metastasis or spinal cord compression
- •Requires prostatectomy, radiation therapy, chemotherapy, and anti-androgen therapy during the clinical trial period
- •Urinary tract obstruction
- •Cardiovascular disease
- •Significant impairments in the digestive system, respiratory system, endocrine system, and central nervous system
- •Uncontrolled diabetes
- •Allergic reaction or hypersensitivity to any ingredient of the investigational product or to a synthetic GnRH or GnRH analogs
- •Severe asthma, severe vascular edema, and severe hives
- •Significant infection
- •Lack of self-determination due to psychiatric illness
- •Participating in another interventional clinical trial
- •Pregnant or unwilling to use medically approved contraception
- •Deemed inappropriate to participate in this clinical trial by the investigator
研究组 & 干预措施
DKF-MA102
Experimental
Leuprorelin acetate
干预措施: DKF-MA102 (Drug)
结局指标
主要结局
Percentage of participants
时间窗: Week 24
Percentage of participants with testosterone suppression(≤ 50ng/dL) from Week 4 to Week 24
Percentage of participants
时间窗: Week 4
Percentage of participants with testosterone suppression(≤ 50ng/dL) at Week 4
次要结局
- Serum prostate specific antigens(PSA)(Week 24)
- Quality of life(FACT-P)(Week 24)
- Serum luteinizing hormone(LH) levels(Week 24)
- Percentage of participants(Week 24)
研究者
研究点 (8)
Loading locations...
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