Status:
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
Lead Sponsor:
Shehzad Basaria, M.D.
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Prostate Cancer
Prostate Cancer (Adenocarcinoma)
Eligibility:
MALE
40+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Prostate cancer is the most common type of cancer in men. At the time of initial diagnosis, most men have disease that is confined to the prostate and are typically managed through surveillance or loc...
Eligibility Criteria
Inclusion
- Male sex
- Age 40 years and older
- Diagnosis of prostate cancer
- Androgen deprivation therapy
- Presence of 5 or more hot flashes a day that are considered moderate to severe
- Ability to sign the inform consent
- Willing to use reliable methods of contraception if partner is of childbearing age
- Ability to record hot flashes electronically
Exclusion
- Use of abiraterone acetate
- Use of docetaxel and other chemotherapeutic agents
- Liver cirrhosis
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal
- Total bilirubin above the upper limit of normal
- Glomerular filtration rate \< 30 mL/min
- Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics
- Use of over-the-counter hormonal agents or herbal compounds
- Current use of CYP1A2 inhibitors
- Ingestion of alcohol within 2 weeks prior to the baseline visit
- Inability to abstain from alcohol use during the study period.
Key Trial Info
Start Date :
January 14 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06957691
Start Date
January 14 2026
End Date
December 31 2028
Last Update
December 26 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115