Fezolinetant for Hot Flashes in Men Having Hormone Treatment for Prostate Cancer
Tests fezolinetant against placebo for hot flashes in men treated for prostate cancer.
Plain-language title generated from the registry record
Registry title: A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)
Key facts
- Where
- Shatin, Hong KongSee the site
- Phase
- Phase 2
Where in Hong Kong
- Prince of Wales HospitalShatin, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT07568236
- Record updated
- 7 October 2026
- Original description
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.Read full original descriptionShow less
A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)
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.
Inclusion: 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: 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).