Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy
Phase 2
60
about 3 years
40+
Male only
1 site in MA
What this study is about
This trial is testing a treatment called fezolinetant to see if it can help men with prostate cancer who are getting androgen deprivation therapy experience fewer hot flashes (vasomotor symptoms). The main questions being answered are whether fezolinetant improves the frequency and severity of hot flashes, whether it causes liver damage, and whether it improves quality of life. Participants will take either fezolinetant or a placebo daily for 4 weeks while visiting the clinic every two weeks for checkups and tests.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Placebo
- 2.Take fezolinetant - reference formulation
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
GENITO URINARY SYSTEM AND SEX HORMONES
oral (Oral Tablet)
Primary: Change in the Frequency of Vasomotor Symptoms Through Daily Hot Flash Diary from Baseline to 4 Weeks
Secondary: Change in fatigue, as assessed using the using the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire, Change in fatigue, as assessed using the using the Hypogonadism Energy Diary questionnaire, Change in glycated hemoglobin (HbA1c) level, Change in inflammatory status, as assessed by measuring high-sensitivity C-reactive protein (hsCRP) levels, Change in overall quality of life, as assessed using the Short Form-36 questionnaire, Change in quality-of-life symptoms related to hot flashes, as assessed using the Hot Flash-Related Daily Interference Scale, Change in sleep quality, as assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance questionnaire
Oncology