RecruitingPhase 2NCT06957691

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)

Sponsor

Shehzad Basaria, M.D.

Enrollment

60 participants

Start Date

Jan 14, 2026

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Prostate Carcinoma Prostate Neoplasm Prostate Cancer (Adenocarcinoma)Vasomotor Symptoms Prostate Adenocarcinoma Androgen Deprivation Therapy Prostate Cancer Metastatic Disease Prostate Cancer Recurrent Prostate Cancer With Bone Metastasis Vasomotor Disturbance Vasomotor Symptoms (VMS)Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men Vasomotor Symptoms; Hot Flashes Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

Summary

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

Eligibility

Sex: MALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called fezolinetant — originally developed to treat hot flashes in menopausal women — can also help men with prostate cancer who experience severe hot flashes from hormone therapy (androgen deprivation therapy). Hot flashes are a very common and disruptive side effect of this treatment. **You may be eligible if...** - You are a man aged 40 or older - You have prostate cancer and are currently on hormone therapy (androgen deprivation therapy) - You experience 5 or more moderate-to-severe hot flashes per day, or at least 35 per week - You are able to record your hot flashes electronically **You may NOT be eligible if...** - You are on certain medications including abiraterone, chemotherapy, certain antidepressants (SSRIs/SNRIs), or opioids - You have liver disease (cirrhosis) or significantly abnormal liver function tests - You have very low kidney function - You have a partner of childbearing age and are unwilling to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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