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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

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

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

40 years and older

Sex

Male

Healthy volunteers

Not accepted

Sponsor

Shehzad Basaria, M.D.

Last updated on ClinicalTrials.gov

August 17, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites