NCT07568236RecruitingPhase 2
A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)
A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 5 Oct 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Prostate cancer
- NCT number
- NCT07568236
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 54
- From 5 Oct 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.