Not Yet RecruitingPhase 2

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

Hong Kong54 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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:
✕. 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)

What they're measuring

Hot flush severity

Timeframe: Baseline, week 3, week 7 and week 11

Daily hot flush score

Timeframe: Baseline, week 3, week 7 and week 11

Trial details

NCT IDNCT07568236

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Alex LIU, RCSEd, MBBS

35052625 alexliu@surgery.cuhk.edu.hk

View on ClinicalTrials.gov More Vasomotor Symptoms trials