Fezolinetant for hot flashes in men receiving androgen-deprivation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  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.

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• Acupuncture to ease hot flashes in men on hormone therapy for prostate cancer

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• Home-based telerehabilitation for rural men on hormone therapy for metastatic prostate cancer

  This trial tests whether a home telerehabilitation program helps men in rural areas receiving androgen deprivation therapy for metastatic prostate cancer feel and function better than home exercise without the technology.

  Recruiting University of Utah · Salt Lake City, Utah · NCT07032584

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.