A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)
2026年4月28日 更新者：NG Chi Fai、Chinese University of Hong Kong
A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
54
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Alex LIU, RCSEd, MBBS
- 电话号码：35052625
- 邮箱：alexliu@surgery.cuhk.edu.hk
学习地点
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Shatin、香港
- Prince of Wales Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment Arm
Fezolinetant 45 mg orally once daily for 12 weeks.
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Fezolinetant 45 mg orally once daily for 12 weeks.
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安慰剂比较：Placebo Arm
Placebo orally once daily for 12 weeks.
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安慰剂每天口服一次，持续 12 周。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Hot flush severity
大体时间：Baseline, week 3, week 7 and week 11
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Participants will document daily VMS episodes categorised as mild, moderate, severe, or very severe.
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Baseline, week 3, week 7 and week 11
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Daily hot flush score
大体时间：Baseline, week 3, week 7 and week 11
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Calculatedusing the formula: (1 × mild) + (2 × moderate) + (3 × severe) + (4 × very severe) divided by the number of diary days completed in that week.
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Baseline, week 3, week 7 and week 11
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patient reported quality of life by QLQ-C30
大体时间：Baseline, week 4, week 8 and week 12
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Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life
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Baseline, week 4, week 8 and week 12
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Sleep Quality
大体时间：Baseline, week 4, week 8 and week 12
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By Pittsburgh Sleep Quality Index (PSQI).
PSQI is scored by summing seven component scores (0-3 each) to produce a global score ranging from 0 to 21.
A total score greater than 5 indicates poor sleep quality.
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Baseline, week 4, week 8 and week 12
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Mood status
大体时间：Baseline, week 4, week 8 and week 12
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By Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9-item screening tool used to measure depression severity, with a total score ranging from 0 to 27.
Scores are interpreted as: 0-4 (none-minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe).
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Baseline, week 4, week 8 and week 12
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Lower urinary tract symptoms (LUTS)
大体时间：Baseline, week 4, week 8 and week 12
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Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)
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Baseline, week 4, week 8 and week 12
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Patient reported quality of life by Hot Flash-Related Daily Interference Scale (HFRDIS)
大体时间：Baseline, week 4, week 8 and week 12
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HFRDIS) is a 10-item, self-report tool measuring how vasomotor symptoms (hot flashes) impact daily life over the past week.
Scores are summed across 10 items on a 0-10 scale (total 0-100), with higher scores indicating greater interference.
Validated cut-points for severity are mild (0-3.9),
moderate (4-6.9), and severe (7-10)
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Baseline, week 4, week 8 and week 12
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Adverse Events
大体时间：Baseline, Week 4, Week 8 and Week 12
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CTCAE rectal toxicity, Grade 1-5 for any rectal toxicity, the higher the score the more severe the toxicity
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Baseline, Week 4, Week 8 and Week 12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Chi Fai NG, MD、Chinese University of Hong Kong
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Johnson KA, Martin N, Nappi RE, Neal-Perry G, Shapiro M, Stute P, Thurston RC, Wolfman W, English M, Franklin C, Lee M, Santoro N. Efficacy and Safety of Fezolinetant in Moderate to Severe Vasomotor Symptoms Associated With Menopause: A Phase 3 RCT. J Clin Endocrinol Metab. 2023 Jul 14;108(8):1981-1997. doi: 10.1210/clinem/dgad058.
- Teleni L, Chan RJ, Chan A, Isenring EA, Vela I, Inder WJ, McCarthy AL. Exercise improves quality of life in androgen deprivation therapy-treated prostate cancer: systematic review of randomised controlled trials. Endocr Relat Cancer. 2016 Feb;23(2):101-12. doi: 10.1530/ERC-15-0456. Epub 2015 Nov 19.
- Challapalli A, Edwards SM, Abel P, Mangar SA. Evaluating the prevalence and predictive factors of vasomotor and psychological symptoms in prostate cancer patients receiving hormonal therapy: Results from a single institution experience. Clin Transl Radiat Oncol. 2018 Mar 21;10:29-35. doi: 10.1016/j.ctro.2018.03.002. eCollection 2018 Mar.
- Irani J, Salomon L, Oba R, Bouchard P, Mottet N. Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial. Lancet Oncol. 2010 Feb;11(2):147-54. doi: 10.1016/S1470-2045(09)70338-9. Epub 2009 Dec 4.
- Moraska AR, Atherton PJ, Szydlo DW, Barton DL, Stella PJ, Rowland KM Jr, Schaefer PL, Krook J, Bearden JD, Loprinzi CL. Gabapentin for the management of hot flashes in prostate cancer survivors: a longitudinal continuation Study-NCCTG Trial N00CB. J Support Oncol. 2010 May-Jun;8(3):128-32.
- Frisk J, Spetz AC, Hjertberg H, Petersson B, Hammar M. Two modes of acupuncture as a treatment for hot flushes in men with prostate cancer--a prospective multicenter study with long-term follow-up. Eur Urol. 2009 Jan;55(1):156-63. doi: 10.1016/j.eururo.2008.02.002. Epub 2008 Feb 14.
- Morga A, Ajmera M, Gao E, Patterson-Lomba O, Zhao A, Mancuso S, Siddiqui E, Kagan R. Systematic review and network meta-analysis comparing the efficacy of fezolinetant with hormone and nonhormone therapies for treatment of vasomotor symptoms due to menopause. Menopause. 2024 Jan 1;31(1):68-76. doi: 10.1097/GME.0000000000002281. Epub 2023 Nov 27.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年3月31日
研究注册日期
首次提交
2026年4月21日
首先提交符合 QC 标准的
2026年4月28日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年4月28日
最后验证
2026年4月1日
更多信息
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