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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

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)

Who can join

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

Age
40 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

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: * Take fezolinetant or a placebo every day for 4 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of the number of times and intensity that they experience hot flashes"
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 helps hot flashes in men age 40 or older with prostate cancer who get treatment to lower male hormones. It compares fezolinetant with a placebo (a pill with no active medicine) taken daily for 4 weeks. Researchers will also check liver safety and effects on sleep, mood, energy, sexual function, quality of life, and how the body uses food for energy.

The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy. The main questions it aims to answer are: * Does fezolinetant improve the frequency and severity of hot flashes? * Does fezolinetant cause any harm to the liver? * Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters? Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine. Participants will: * Take fezolinetant or a placebo every day for 4 weeks * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of the number of times and intensity that they experience hot flashes

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

Eligibility

Who can join

  • Are male and age 40 or older.
  • Have prostate cancer.
  • Get androgen deprivation therapy, a treatment to lower male hormones.
  • Have at least 5 moderate-to-severe hot flashes a day or 35 a week.
  • Can sign a form agreeing to take part in the study.
  • Will use reliable birth control if your partner can become pregnant.
  • Can record hot flashes on an electronic device.

Who can't join

  • Take abiraterone acetate, docetaxel, or other chemotherapy drugs.
  • Have cirrhosis (scarring of the liver), or ALT, AST, or bilirubin blood test results above normal.
  • Have a kidney filtering rate below 30 mL/min, a sign of poor kidney function.
  • Take certain antidepressants (SSRIs, SNRIs, or tricyclics), calming medicines, or sleeping pills to treat hot flashes.
  • Use hormone products sold without a prescription or herbal products.
  • Take CYP1A2 inhibitors, medicines that block a substance that helps the body break down drugs.
  • Had alcohol within 2 weeks before the starting visit.
  • Cannot avoid alcohol during the study.

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

Official eligibility 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.

Study sites (1)

MA