Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

Launched by UNIVERSITY OF VERMONT · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called fezolinetant to help men with prostate cancer who are experiencing bothersome hot flashes as a side effect of their treatment. Hot flashes can be uncomfortable and may make it difficult for these men to continue their cancer treatment. The goal of this study is to see if fezolinetant can reduce these hot flashes without using hormones, as it is already approved for treating hot flashes in menopausal women.

To participate in this study, men must be at least 18 years old and currently receiving a specific type of treatment for prostate cancer that lowers testosterone. They should be having at least four hot flashes a day that are bothersome enough for them to seek help. Eligible participants will need to be stable on their current cancer medications for at least 28 days and have a life expectancy of at least six months. The study is not yet recruiting participants, but it aims to provide a new way to improve the quality of life for men dealing with this challenging side effect of their cancer treatment.

Gender

MALE

Eligibility criteria

• 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).