OncoMatch/Clinical Trials/NCT06957691
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
Is NCT06957691 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies fezolinetant - reference formulation for prostate cancer.
Treatment: fezolinetant - reference formulation — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Prostate Cancer Metastatic Disease
Prior therapy
Must have received: androgen deprivation therapy
Androgen deprivation therapy
Cannot have received: abiraterone acetate (abiraterone acetate)
Use of abiraterone acetate
Cannot have received: chemotherapy (docetaxel)
Use of docetaxel and other chemotherapeutic agents
Lab requirements
Kidney function
glomerular filtration rate < 30 mL/min
Liver function
ALT or AST above the upper limit of normal; liver cirrhosis; total bilirubin above the upper limit of normal
Liver cirrhosis; ALT or AST above the upper limit of normal; total bilirubin above the upper limit of normal; glomerular filtration rate < 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Brigham and Women's Hospital · Boston, Massachusetts
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