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

The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy. The main questions it aims to answer are: * Does fezolinetant improve the frequency and severity of hot flashes? * Does fezolinetant cause any harm to the liver? * Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters? Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine. Participants will: *

Trial Details

NCT ID
NCT06957691
Phase
PHASE2
Sponsor
Shehzad Basaria, M.D.
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • fezolinetant - reference formulation
  • Placebo
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Age 40 years and older
  • Diagnosis of prostate cancer
  • Androgen deprivation therapy
  • Presence of 5 or more moderate-to-severe hot flashes per day or 35 or more moderate-to-severe hot flashes per week

For full eligibility, visit ClinicalTrials.gov.

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