RecruitingPhase 2NCT06972875

Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study

Sponsor

University of Vermont

Enrollment

32 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Androgen Deprivation Therapy Prostate CA

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing fezolinetant — a non-hormonal pill already approved to treat hot flashes in women going through menopause — to see if it also helps men with prostate cancer who experience hot flashes as a side effect of hormone-blocking therapy. **You may be eligible if...** - You are a man aged 18 or older - You are receiving androgen deprivation therapy (ADT) — such as leuprolide, degarelix, or relugolix — for prostate cancer, either alone or combined with other hormone blockers - Your hormone therapy has been at a stable dose for at least 28 days - You experience hot flashes **You may NOT be eligible if...** - You have severe liver problems - You take certain medications that interact with fezolinetant - Your hormone therapy is being changed or stopped soon Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFezolinetant

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.

Locations(1)

University of Vermont Medical Center

Burlington, Vermont, United States

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NCT06972875

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