Fezolinetant for hot flashes in men receiving androgen-deprivation therapy
Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study
This test will try whether fezolinetant reduces hot flashes in men with prostate cancer who get them from androgen deprivation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Vermont Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Burlington, Vermont) |
| Trial ID | NCT06972875 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial gives fezolinetant, a non-hormonal neurokinin-3 receptor antagonist, to men who are experiencing bothersome hot flashes while on androgen deprivation therapy for prostate cancer. Eligible participants are adult men on stable ADT (including those receiving androgen receptor pathway inhibitors) who report frequent hot flashes and will receive study drug with scheduled clinic visits. The study will track changes in hot flash frequency and severity and monitor safety and tolerability during the treatment and extension phases. Because fezolinetant is already approved for menopausal hot flashes in women, investigators will leverage existing dosing and safety data while specifically measuring effects in the male ADT population.
Who should consider this trial
Good fit: Men aged 18 or older who are receiving androgen deprivation therapy for prostate cancer, are on a stable hormonal regimen, and have bothersome hot flashes are the ideal candidates.
Not a fit: Men with minimal or non-ADT-related hot flashes, those with contraindications to fezolinetant, or those unable to attend the single-center visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If effective, fezolinetant could reduce hot flashes and improve quality of life for men on ADT without adding hormone therapy.
How similar studies have performed: Fezolinetant has shown efficacy for menopausal hot flashes in women, but its use for ADT-related hot flashes in men is novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥ 18 years Men who are currently receiving Androgen Deprivation Therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). Men receiving Androgen Receptor Pathway Inhibitors (ARPI) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible. Patients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Additional ARPI agents (e.g. abiraterone or enzalutamide) are allowed to be added during the Extension Phase of the trial, but not during the Treatment Phase. Patients receiving radiation therapy during the study period are eligible. An eligible patient must have bothersome hot flashes for ≥ 7 days prior to consent, resulting in an average of four or more hot flashes per day of sufficient severity to cause the patient to seek therapeutic intervention. Life Expectancy of 6 months or greater. Language: In order to complete the mandatory participant-completed measures, participants must be able to speak and read English. Exclusion Criteria: Current or future planned use of any of the following agents during the study period: drugs that are not FDA approved for use in humans, any drug with category X interactions with fezolinetant; androgens, estrogens, progesterone analogs, or complementary/alternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration. Stable dosing (≥ 1 month) of gabapentin, cholinergic agonists, cholinesterase inhibitors for other indications is permitted. History of cirrhosis Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 X ULN or total bilirubin \> ULN eGFR \<30 mL/min/1.73 m2 based on reported MDRD estimate. Current use of CYP1A2 inhibitors (fezolinetant is a substrate of CYP1A2).
Where this trial is running
Burlington, Vermont
- University of Vermont Medical Center — Burlington, Vermont, United States (Recruiting)
Study contacts
- Study coordinator: Steven Ades, MD, MSc
- Email: steven.ades@med.uvm.edu
- Phone: 802-656-2021
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.