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Clinical Trials/NCT07568236
NCT07568236Not yet recruitingPhase 2

A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)

Chinese University of Hong Kong1 site in 1 country54 target enrollmentStarted: July 1, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
54
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Detailed Description

Participants will be randomized in a 1:1 manner to receive fezolinetant 45 mg or placebo orally once daily for 12 weeks in total, with the primary and secondary outcomes being assessed at week 4, 8 and 12 with standardized questionnaires, symptom diaries, blood taking, and clinical history taking in the clinic setting.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

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:
  • •- 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

NG Chi Fai

Professor

Chinese University of Hong Kong

Study Sites (1)

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