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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
Sponsor: Shehzad Basaria, M.D.
Summary
The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy. The main questions it aims to answer are: * Does fezolinetant improve the frequency and severity of hot flashes? * Does fezolinetant cause any harm to the liver? * Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters? Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine. Participants will: * Take fezolinetant or a placebo every day for 4 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of the number of times and intensity that they experience hot flashes
Official title: 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 (Fezo-ADT Trial)
Key Details
Gender
MALE
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-01-14
Completion Date
2028-12-31
Last Updated
2026-03-09
Healthy Volunteers
No
Conditions
Interventions
fezolinetant - reference formulation
Daily oral administration of fezolinetant at a dose of 45 mg
Placebo
Daily oral administration of placebo
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States