Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

Phase 2

Not yet recruiting

• Conditions: Prostate CA; Androgen Deprivation Therapy
• Interventions: Drug: Fezolinetant

• Registration Number: NCT06972875
• Lead Sponsor: University of Vermont

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-28
• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-15
• Last Update Posted: 2025-05-15
• Primary Completion: 2027-01
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 32

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fezolinetant treatment	Fezolinetant	Adult male patients with prostate cancer experiencing hot flashes due to androgen deprivation therapy will be treated with fezolinetant. Hot flashes will be monitored to assess improvements resulting from the investigational drug

Primary Outcome Measures

Name	Time	Method
Reduction in Hot Flash Score	28 day	Assess the effect of fezolinetant 45 mg daily on the 7-day period participant-reported Hot Flash Score (HFS) at 4 weeks relative to baseline. The HFS sums the number of hot flashes multiplied by the intensity of each hot flash to estimate the overall hot flash burden during a 24 hour period, averaged over a 7 day period.

Secondary Outcome Measures

Name	Time	Method
To characterize the safety and adverse event profile of fezolinetant in the study population.	28 day	To characterize the safety and adverse event profile of fezolinetant in the study population by monitoring adverse events.
Measure Compliance of Fezolinetant Therapy in Men	28 day	Compliance will be assessed based on a combination of the Hot Flash diary (HFD) responses, the weekly phone calls during the Treatment Phase, and the participant visit at the end of the Treatment Phase.
Hot Flash Frequency	28 day	To assess the effect of fezolinetant on participant-reported Hot Flash Frequency (HFF) at 4 weeks relative to baseline.
Patient Reported Quality of Life	28 day	To measure the impact of fezolinetant treatment participant-reported quality of life and hot flash interference, as measured by the Hot Flash Related Daily Interference Scale (HFRDIS) after 4 weeks compared to baseline. The HFRDIS is a 10-item instrument developed and validated to assess the interference of hot flashes on multiple specific important quality of life dimensions in this patient population.

Trial Locations

Locations (1)

University of Vermont Medical Center; 🇺🇸 Burlington, Vermont, United States