Fezolinetant for hot flashes in men on hormone therapy for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled study conducted across multiple centers to see if fezolinetant helps relieve vasomotor symptoms in men on androgen deprivation therapy for prostate cancer. Eligible participants are adults on ADT with a baseline daily hot flush score of at least 4, and a Karnofsky performance status of 70% or higher. Participants are assigned to fezolinetant 45 mg or placebo once daily for 12 weeks, with assessments at weeks 4, 8, and 12 using questionnaires, diaries, blood tests, and clinic visits. The trial aims to determine efficacy and safety through patient-reported outcomes and clinical data collected at specified intervals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.
3. Active liver disease including:

   \- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT / AST - abnormal INR
4. 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's running

• Prince of Wales Hospital
  Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Chi Fai NG, MD — Chinese University of Hong Kong
• Study coordinator: Alex LIU, RCSEd, MBBS
• Email: alexliu@surgery.cuhk.edu.hk
• Phone: 35052625

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.