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

Inclusion Criteria8

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 Criteria11

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
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.