Actively Recruiting
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
Led by Shehzad Basaria, M.D. · Updated on 2026-03-09
60
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
S
Shehzad Basaria, M.D.
Lead Sponsor
A
Astellas Pharma US, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male sex
- Age 40 years and older
- Diagnosis of prostate cancer
- Receiving androgen deprivation therapy
- Experiencing 5 or more moderate-to-severe hot flashes daily or 35 or more weekly
- Able to give informed consent
- Willing to use reliable contraception if partner can bear children
- Able to record hot flashes electronically
You will not qualify if you...
- Use of abiraterone acetate
- Use of docetaxel or other chemotherapy drugs
- Liver cirrhosis
- Elevated liver enzymes (ALT or AST above normal limits)
- Elevated total bilirubin above normal limits
- Kidney function with glomerular filtration rate less than 30 mL/min
- Use of SSRIs, SNRIs, tricyclic antidepressants, sedatives, or hypnotics
- Use of over-the-counter hormonal or herbal agents
- Current use of CYP1A2 inhibitors
- Alcohol use within 2 weeks before the baseline visit
- Inability to avoid alcohol during the study period
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
E
Elizabeth Borwick
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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