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NCT Number: NCT07568236

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

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.

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Key information

Conditions

Vasomotor Symptoms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Cancer Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fezolinetant

Drug

Fezolinetant 45 mg orally once daily for 12 weeks.

Placebo

Drug

Placebo orally once daily for 12 weeks.

Primary outcomes

  1. Hot flush severity

    Time frame: Baseline, week 3, week 7 and week 11

    Participants will document daily VMS episodes categorised as mild, moderate, severe, or very severe.

  2. Daily hot flush score

    Time frame: Baseline, week 3, week 7 and week 11

    Calculatedusing the formula: (1 × mild) + (2 × moderate) + (3 × severe) + (4 × very severe) divided by the number of diary days completed in that week.

Secondary outcomes

  1. Patient reported quality of life by QLQ-C30

    Time frame: Baseline, week 4, week 8 and week 12

    Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life

  2. Sleep Quality

    Time frame: Baseline, week 4, week 8 and week 12

    By Pittsburgh Sleep Quality Index (PSQI). PSQI is scored by summing seven component scores (0-3 each) to produce a global score ranging from 0 to 21. A total score greater than 5 indicates poor sleep quality.

  3. Mood status

    Time frame: Baseline, week 4, week 8 and week 12

    By Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item screening tool used to measure depression severity, with a total score ranging from 0 to 27. Scores are interpreted as: 0-4 (none-minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe).

  4. Lower urinary tract symptoms (LUTS)

    Time frame: Baseline, week 4, week 8 and week 12

    Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)

  5. Patient reported quality of life by Hot Flash-Related Daily Interference Scale (HFRDIS)

    Time frame: Baseline, week 4, week 8 and week 12

    HFRDIS) is a 10-item, self-report tool measuring how vasomotor symptoms (hot flashes) impact daily life over the past week. Scores are summed across 10 items on a 0-10 scale (total 0-100), with higher scores indicating greater interference. Validated cut-points for severity are mild (0-3.9), moderate (4-6.9), and severe (7-10)

  6. Adverse Events

    Time frame: Baseline, Week 4, Week 8 and Week 12

    CTCAE rectal toxicity, Grade 1-5 for any rectal toxicity, the higher the score the more severe the toxicity

Study contacts

Contact information is provided by the study sponsor or research team.

Alex LIU, RCSEd, MBBS

CONTACT

[email protected]

35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 5, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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