Study of Fezolinetant to Reduce Hot Flashes in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

What this Trial Is About

Researchers are evaluating the drug fezolinetant for men with prostate cancer who experience hot flashes caused by treatments that lower testosterone. Hot flashes can reduce quality of life and make it harder for patients to continue their therapy. Fezolinetant is being studied as a non-hormonal option to reduce hot flashes, and it is already approved for this use in menopausal women. This is a Phase 2 clinical trial sponsored by the University of Vermont. Participants will receive fezolinetant orally once daily at a dose of 45 mg for 28 days. The study focuses on men undergoing androgen deprivation therapy for prostate cancer, including those using androgen receptor pathway inhibitors or radiation therapy. Hot flashes will be closely monitored throughout the treatment phase to assess any improvements from the investigational drug. During the study, participants will be evaluated for changes in their hot flash score, frequency of hot flashes, and quality of life. Safety and side effects of fezolinetant will also be monitored. Compliance with the treatment will be measured over the 28-day period. Participants must be able to speak and read English to complete required questionnaires. The trial will continue until February 2027.

Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer