Actively Recruiting
Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer
Led by University of Vermont · Updated on 2026-02-05
32
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.
CONDITIONS
Official Title
Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older
- Currently receiving androgen deprivation therapy for prostate cancer, including orchiectomy or hormone treatments like leuprolide, degarelix, or relugolix
- Receiving androgen receptor pathway inhibitors such as abiraterone, enzalutamide, apalutamide, or darolutamide are eligible
- Stable dose of all hormonal therapies for at least 28 days before joining and not planning to stop therapy for at least 42 days after joining
- Patients receiving radiation therapy during the study period are eligible
- Experiencing bothersome hot flashes for 7 or more days before consent, with an average of four or more hot flashes per day that require treatment
- Life expectancy of 6 months or more
- Able to speak and read English to complete study questionnaires
You will not qualify if you...
- Current or planned use of drugs not approved by the FDA or drugs with category X interactions with fezolinetant during the study
- Use of androgens, estrogens, progesterone analogs, or alternative medicines for hot flashes during the study
- History of liver cirrhosis
- Elevated liver enzymes (ALT or AST) at least twice the upper limit of normal or high total bilirubin
- Kidney function with eGFR below 30 mL/min/1.73 m2
- Current use of CYP1A2 inhibitors, as fezolinetant is affected by these
- Prior use of excluded agents allowed if stopped before joining
- Stable use of gabapentin, cholinergic agonists, or cholinesterase inhibitors for other conditions is allowed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
Research Team
S
Steven Ades, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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