Fezolinetant to reduce hot flashes in men on androgen-deprivation therapy
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)
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 |
| Enrollment | 60 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06957691 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 * 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 this trial is running
Boston, Massachusetts
- 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: Elizabeth Borwick
- Email: eborwick@bwh.harvard.edu
- Phone: 617-525-8407
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.