NCT07568236尚未招募2 期
A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.
详细描述
Participants will be randomized in a 1:1 manner to receive fezolinetant 45 mg or placebo orally once daily for 12 weeks in total, with the primary and secondary outcomes being assessed at week 4, 8 and 12 with standardized questionnaires, symptom diaries, blood taking, and clinical history taking in the clinic setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients aged at least 18 years old on the index date
- •Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease
- •Karnofsky index score of 70% or more
- •Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline
- •Baseline daily hot flush score ≥4
排除标准
- •Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine
- •Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.
- •Active liver disease including:
- •- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT / AST - abnormal INR
- •Severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2)
研究者
NG Chi Fai
Professor
Chinese University of Hong Kong
研究点 (1)
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