Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy
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)
Run by Brigham and Women's Hospital · NCT06957691 · Data updated 2026-11-12
This trial will test whether taking fezolinetant once daily for 4 weeks reduces how often and how severe hot flashes are in men with prostate cancer who are on androgen-deprivation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | January 14, 2026 |
| Main results expected | August 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | August 17, 2026 |
| Trial ID | NCT06957691 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 40 years or older with prostate cancer who are receiving androgen-deprivation therapy and have at least 5 moderate-to-severe hot flashes per day, who can use an electronic diary and attend regular clinic visits, are the intended participants.
✕Probably not a fit
Men with significant liver disease or abnormal liver tests, severe kidney impairment, current use of excluded medications (for example abiraterone, certain antidepressants, CYP1A2 inhibitors), recent chemotherapy, or ongoing heavy alcohol use are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, placebo-controlled Phase 2 trial gives participants either fezolinetant or a placebo daily for 4 weeks and compares hot-flash frequency and severity. Men keep an electronic diary of hot flashes and return to the clinic every two weeks for safety checks and blood tests, including liver enzymes. Secondary measures include quality of life, sleep, fatigue, mood, sexual function, and metabolic parameters. Key eligibility includes men aged 40 or older with prostate cancer on androgen-deprivation therapy who report at least 5 moderate-to-severe hot flashes per day.
Why it matters
Potential benefit: If effective, fezolinetant could substantially reduce hot flashes and improve sleep and daily comfort for men experiencing vasomotor symptoms on androgen-deprivation therapy.
How similar studies have gone: NK3 receptor antagonists like fezolinetant have shown positive results for reducing menopausal hot flashes in women, but there is limited prior evidence specifically in men on androgen-deprivation therapy, making this a proof-of-concept application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male sex * Age 40 years and older * Diagnosis of prostate cancer * Androgen deprivation therapy * Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week * 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 Criteria: * 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 if prescribed for the treatment of hot flashes * 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.
Where it's running
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Shehzad S Basaria, MD — Brigham and Women's Hospital
- Study coordinator: Caroline Veteri
- Email: cveteri@bwh.harvard.edu
- Phone: 617-525-8407
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.