Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study
University of Vermont
Summary
This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: Age ≥ 18 years Men who are currently receiving Androgen Deprivation Therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). Men receiving Androgen Receptor Pathway Inhibitors (ARPI) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible. Patients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for a…
Interventions
- DrugFezolinetant
Participants will receive fezolinetant for 28 days at FDA approved dosing and schedule of 45 mg po (per os/by mouth) once daily for treatment of hot flashes in menopausal women.
Location
- University of Vermont Medical CenterBurlington, Vermont