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

Launched by SHEHZAD BASARIA, M.D. · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called fezolinetant to see if it can help reduce hot flashes in men with prostate cancer who are receiving androgen deprivation therapy, a treatment that lowers hormone levels. The trial aims to find out if fezolinetant can decrease the number and intensity of hot flashes, check if it has any harmful effects on the liver, and see if it improves overall quality of life, including sleep, mood, and energy levels. Researchers will compare the effects of fezolinetant to a placebo, which is a pill that looks like the medication but doesn’t contain any active ingredients.

To participate in this trial, men must be 40 years or older, diagnosed with prostate cancer, and currently undergoing androgen deprivation therapy. They should experience at least five moderate to severe hot flashes a day. Participants will take a daily dose of either fezolinetant or the placebo for 12 weeks, visit the clinic every four weeks for check-ups, and keep a diary to track their hot flashes. It’s important to note that some medications and health conditions may exclude individuals from participating, so potential volunteers should discuss their eligibility with their healthcare provider.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male sex
• • Age 40 years and older
• • Diagnosis of prostate cancer
• • Androgen deprivation therapy
• • Presence of 5 or more hot flashes a day that are considered moderate to severe
• • Ability to sign the inform consent
• Exclusion Criteria:
• • Use of abiraterone acetate
• • Use of docetaxel and other chemotherapeutic agents
• • Liver cirrhosis
• • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal
• • Total bilirubin ≥ 2 times 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 agents or herbal compounds
• • Use of CYP1A2 inhibitors