Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2028-12-31

Target enrollment:

Participant gender:

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 and 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 12 weeks * Visit the clinic once every 4 weeks for checkups and tests * Keep a diary of the number of times and intensity that they experience hot flashes

Phase:

PHASE2

Details

Lead Sponsor:

Shehzad Basaria, M.D.

Collaborator:

Astellas Pharma US, Inc.

Treatments:

fezolinetant