Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor S… (NCT06957691) | Clinical Trial Compass
RecruitingPhase 2
Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
United States60 participantsStarted 2026-01-14
Plain-language summary
The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.
The main questions it aims to answer are:
* Does fezolinetant improve the frequency and severity of hot flashes?
* Does fezolinetant cause any harm to the liver?
* Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?
Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.
Participants will:
* Take fezolinetant or a placebo every day for 4 weeks
* Visit the clinic once every 2 weeks for checkups and tests
* Keep a diary of the number of times and intensity that they experience hot flashes
Who can participate
Age range
40 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male sex
* Age 40 years and older
* Diagnosis of prostate cancer
* Androgen deprivation therapy
* Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week
* Ability to sign the inform consent
* Willing to use reliable methods of contraception if partner is of childbearing age
* Ability to record hot flashes electronically
Exclusion Criteria:
* Use of abiraterone acetate
* Use of docetaxel and other chemotherapeutic agents
* Liver cirrhosis
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal
* Total bilirubin above the upper limit of normal
* Glomerular filtration rate \< 30 mL/min
* Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics
* Use of over-the-counter hormonal agents or herbal compounds
* Current use of CYP1A2 inhibitors
* Ingestion of alcohol within 2 weeks prior to the baseline visit
* Inability to abstain from alcohol use during the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Frequency of Vasomotor Symptoms Through Daily Hot Flash Diary from Baseline to 4 Weeks
Timeframe: From baseline to the end of treatment at 4 weeks.
2
Hepatic safety, as assessed by measuring liver function tests
Timeframe: From baseline to the end of treatment at 4 weeks.