Prostate Cancer, Vasomotor Symptoms
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGFezolinetant
Fezolinetant 45 mg orally once daily for 12 weeks.
DRUGPlacebo
Placebo orally once daily for 12 weeks.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot flush severity | Baseline, week 3, week 7 and week 11 | Participants will document daily VMS episodes categorised as mild, moderate, severe, or very severe. |
| Daily hot flush score | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient reported quality of life by QLQ-C30 | 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 |
| Sleep Quality | 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. |
| Mood status | 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). |
| Lower urinary tract symptoms (LUTS) | Baseline, week 4, week 8 and week 12 | Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse) |
| Patient reported quality of life by Hot Flash-Related Daily Interference Scale (HFRDIS) | 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) |
| Adverse Events | 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 |
Countries
Hong Kong
Contacts
CONTACTAlex LIU, RCSEd, MBBS
PRINCIPAL_INVESTIGATORChi Fai NG, MD
Chinese University of Hong Kong
Outcome results
None listed