Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT06972875
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Androgen Deprivation Therapy
  • Prostate CA

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fezolinetant — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 18, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: fezolinetant treatment
    Adult male patients with prostate cancer experiencing hot flashes due to androgen deprivation therapy will be treated with fezolinetant. Hot flashes will be monitored to assess improvements resulting from the investigational drug

Primary Outcome Measure

Reduction in Hot Flash Score [ Time Frame: 28 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401
Steven Ades, MD, MSc
[email protected]
(802) 656-2021
Steven Ades, MD MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Burlington, VT

By research site
University of Vermont Medical Center· Burlington, VT

Related Studies