Could a menopause drug cool hot flashes in men with prostate cancer?
NCT ID NCT06972875
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a drug called fezolinetant, already approved for hot flashes in menopausal women, to see if it can reduce hot flashes in men with prostate cancer who are on hormone-lowering therapy. About 32 men will take the drug daily for 28 days. The goal is to measure how much hot flash symptoms improve and to check for any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fezolinetant
- What this could lead to
- If it works, this could offer a non-hormonal option to manage hot flashes in men undergoing prostate cancer treatment, improving daily comfort and treatment adherence.
- What could go wrong
- This is a small, early-phase study with only 32 participants, so results may not apply broadly. The drug is approved for women but not yet proven safe or effective in men.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age ≥ 18 years Men who are currently receiving Androgen Deprivation Therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). Men receiving Androgen Receptor Pathway Inhibitors (ARPI) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible. Patients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Additional ARPI agents (e.g. abiraterone or enzalutamide) are allowed to be added during the Extension Phase of the trial, but not during the Treatment Phase. Patients receiving radiation therapy during the study period are eligible. An eligible patient must have bothersome hot flashes for ≥ 7 days prior to consent, resulting in an average of four or more hot flashes per day of sufficient severity to cause the patient to seek therapeutic intervention. Life Expectancy of 6 months or greater. Language: In order to complete the mandatory participant-completed measures, participants must be able to speak and read English. Exclusion Criteria: Current or future planned use of any of the following agents during the study period: drugs that are not FDA approved for use in humans, any drug with category X interactions with fezolinetant; androgens, estrogens, progesterone analogs, or complementary/alternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration. Stable dosing (≥ 1 month) of gabapentin, cholinergic agonists, cholinesterase inhibitors for other indications is permitted. History of cirrhosis Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 X ULN or total bilirubin \> ULN eGFR \<30 mL/min/1.73 m2 based on reported MDRD estimate. Current use of CYP1A2 inhibitors (fezolinetant is a substrate of CYP1A2).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Vermont Medical Center
RECRUITINGBurlington, Vermont, 05401, United States
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