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

What this Trial Is About

Researchers are evaluating fezolinetant as a potential treatment for hot flashes, also called vasomotor symptoms, in men with prostate cancer who are undergoing androgen deprivation therapy. These hot flashes can be severe and frequent, affecting quality of life, sleep, mood, and other areas. The study aims to find out if fezolinetant reduces the frequency and severity of hot flashes, assess its effects on liver safety, and examine improvements in quality of life, sleep, fatigue, mood, sexual function, and metabolic measures. Participants will be randomly assigned to take either 45 mg of fezolinetant or a placebo by mouth every day for 4 weeks. During this time, they will visit the clinic every two weeks for checkups and tests. The study compares responses between the fezolinetant group and the placebo group to evaluate differences in symptoms and safety. Throughout the study, participants will keep a daily diary tracking how often and how intense their hot flashes are. Researchers will measure changes in hot flash frequency and liver function from the start to the end of treatment. They will also assess quality of life, sleep quality, mood, sexual function, fatigue, inflammation, glucose, and lipid levels. The total participation time is about one month, with safety and symptom monitoring occurring at regular clinic visits.

Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy