A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Vasomotor Symptoms, Prostate Cancer

In brief

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.

Key facts

Study ID

NCT07568236

Run by

Chinese University of Hong Kong

People needed

54

Starts

2026-07-01

Expected to finish

2028-03-31

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged at least 18 years old on the index date
• Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease
• Karnofsky index score of 70% or more
• Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline
• Baseline daily hot flush score ≥4

You may not qualify if…

• Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine
• Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.
• Active liver disease including:
• cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT / AST - abnormal INR
• Severe (eGFR 15 to less than 30 mL/min/1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL/min/1.73 m2)

Where it is running

• Prince of Wales Hospital — Shatin, Hong Kong

Full record on ClinicalTrials.gov

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