Fezolinetant for Hot Flashes in Prostate Cancer

(FLASH Trial)

Overseen By Steven Ades, MD, MSc

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Vermont

Must be taking: Androgen deprivation therapy

Must not be taking: Androgens, estrogens, progesterone

Disqualifiers: Cirrhosis, elevated liver enzymes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

32 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for men with prostate cancer who are having hot flashes due to testosterone-lowering treatments. Participants should be experiencing a certain number of hot flashes per week and must not have conditions that could interfere with the study or pose risks.

Inclusion Criteria

Life Expectancy of 6 months or greater. Language: In order to complete the mandatory participant-completed measures, participants must be able to speak and read English.

I experience severe hot flashes, averaging four or more per day, for at least a week.

I am a man currently on hormone therapy for prostate cancer.

Exclusion Criteria

I have a history of cirrhosis.

My kidney function is severely reduced.

My liver enzymes are higher than normal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fezolinetant to assess its effect on hot flashes over a 4-week period

4 weeks

Weekly phone calls and end-of-treatment visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fezolinetant

Trial Overview The study is testing fezolinetant, a non-hormonal drug approved for managing hot flashes in menopausal women, to see if it can help reduce hot flashes in men undergoing treatment for prostate cancer.

Participant Groups

Group I: fezolinetant treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+