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RecruitingPhase 2

Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether fezolinetant can reduce hot flashes without using hormones. It is for men with prostate cancer who have hot flashes from treatment that lowers testosterone. Fezolinetant is already approved to treat hot flashes in women going through menopause.

This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are a man age 18 or older with prostate cancer.
  • You get treatment that lowers testosterone, either through medicine or surgery to remove the testicles. Men also taking medicines such as abiraterone or enzalutamide may join.
  • Your hormone treatment doses have stayed the same for at least 28 days before signing up. You do not plan to stop them for at least 42 days after signing up.
  • You may add certain prostate cancer drugs during the study’s extension phase, but not during its treatment phase.
  • You have had bothersome hot flashes for at least 7 days before agreeing to join. You average at least 4 a day, and they bother you enough to want treatment.
  • You are expected to live at least 6 months.
  • You can speak and read English to complete the required study forms.
  • You may receive radiation treatment during the study.

Who can't join

  • You use or plan to use drugs not approved by the FDA for humans, or drugs with a serious interaction called a category X interaction with fezolinetant.
  • You use or plan to use hormones or alternative treatments to manage hot flashes. Past use is allowed if you stop before signing up.
  • You have a history of cirrhosis, which is severe liver scarring.
  • Your liver blood tests show ALT or AST levels at least twice the upper normal limit, or total bilirubin above the normal limit.
  • Your kidney filtering test, called eGFR, is below 30.
  • You currently take a CYP1A2 inhibitor, a medicine that affects how your body breaks down fezolinetant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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).

Study sites (1)

VT