A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Fezolinetant
DrugFezolinetant 45 mg orally once daily for 12 weeks.
Placebo
DrugPlacebo orally once daily for 12 weeks.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Treatment ArmExperimental treatment 1 intervention
Group B: Placebo ArmPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hot flush severity
Participants will document daily VMS episodes categorised as mild, moderate, severe, or very severe.
Time frame
Baseline, week 3, week 7 and week 112
Daily hot flush score
Calculatedusing the formula: (1 × mild) + (2 × moderate) + (3 × severe) + (4 × very severe) divided by the number of diary days completed in that week.
Time frame
Baseline, week 3, week 7 and week 11Secondary outcomes
1
Patient reported quality of life by QLQ-C30
Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life
Time frame
Baseline, week 4, week 8 and week 122
Sleep Quality
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.
Time frame
Baseline, week 4, week 8 and week 123
Mood status
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).
Time frame
Baseline, week 4, week 8 and week 124
Lower urinary tract symptoms (LUTS)
Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)
Time frame
Baseline, week 4, week 8 and week 12Sponsors and contacts
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Source ClinicalTrials.gov