Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

NCT06972875 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UVMCC2408
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate CA; Androgen Deprivation Therapy

Keywords

prostate cancer; androgen deprivation therapy; hot flash; fezolinetant

Outcome Measures

Primary Outcomes (1)

• Reduction in Hot Flash Score

  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.

  28 day

Secondary Outcomes (4)

• To characterize the safety and adverse event profile of fezolinetant in the study population.

  28 day

• Measure Compliance of Fezolinetant Therapy in Men

  28 day

• Hot Flash Frequency

  28 day

• Patient Reported Quality of Life

  28 day

Study Arms (1)

fezolinetant treatment

EXPERIMENTAL

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

Drug: Fezolinetant

Interventions

Fezolinetant DRUG

Participants will receive fezolinetant for 28 days at FDA approved dosing and schedule of 45 mg po (per os/by mouth) once daily for treatment of hot flashes in menopausal women.

fezolinetant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Hot Flashes

Interventions

fezolinetant

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Steven Ades, MD, MSc

CONTACT

802-656-2021; steven.ades@med.uvm.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist, Professor of Medicine, Medical Director

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 15, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)