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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called fezolinetant to help men with prostate cancer who experience hot flashes. These hot flashes often result from treatments that lower testosterone, causing discomfort and potentially affecting treatment adherence. Fezolinetant is already used to manage hot flashes in menopausal women, and researchers aim to determine if it works similarly for men. Men experiencing bothersome hot flashes for at least a week, particularly those having four or more hot flashes a day while on hormone treatments for prostate cancer, might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for the trial?

You can continue taking your current hormonal therapies and certain other medications, but you must stop using any drugs not approved by the FDA, those with specific interactions with fezolinetant, and any hormones or alternative medicines for hot flashes before joining the trial.

Is there any evidence suggesting that fezolinetant is likely to be safe for humans?

Research has shown that fezolinetant is already approved for treating hot flashes in menopausal women, indicating a certain level of safety. One study found fezolinetant safe when liver tests did not show major changes, suggesting no serious liver problems occurred during that period.

Fezolinetant is now undergoing a Phase 2 trial for men with prostate cancer. Earlier tests have demonstrated sufficient safety to warrant testing on a larger group. Phase 2 trials typically aim to determine the appropriate dose and further assess safety. This indicates that while researchers continue to gather information, there is some confidence in the drug's safety for this new application. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Fezolinetant is unique because it works differently from traditional treatments for hot flashes in prostate cancer patients. While most current options involve hormone replacement or adjusting androgen deprivation therapy, fezolinetant is a neurokinin-3 receptor antagonist. This means it targets the brain's temperature regulation pathways directly, potentially reducing hot flashes without altering hormone levels. Researchers are excited because this could offer a new way to manage hot flashes with potentially fewer side effects related to hormone manipulation.

What evidence suggests that fezolinetant might be an effective treatment for hot flashes in prostate cancer?

Research shows that fezolinetant is already approved for reducing hot flashes in menopausal women, providing a strong basis for its potential to help men with prostate cancer who experience similar symptoms. The drug blocks a specific part of the brain that helps control body temperature. In this trial, adult male patients with prostate cancer experiencing hot flashes due to androgen deprivation therapy will receive fezolinetant. Although researchers are still studying its use in men, its success in women suggests it could reduce hot flashes without affecting hormone levels. This is crucial for men with prostate cancer, as maintaining stable hormone levels is a key part of their treatment. Early results are promising, but more research is needed to confirm these benefits in men. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06972875

Fezolinetant for Treating Hot Flashes in Men With Prostate ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11157406/

Could menopause drug fezolinetant show promise for ... Whilst fezolinetant is currently only approved for menopause, its potential utility in prostate cancer and male hypogonadism is promising. Appropriate trials ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/604797

Proof-of-Concept Trial to Assess the Efficacy and Safety of ... The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen ...

4. academic.oup.com academic.oup.com/jcem/article/110/9/2509/8140119?rss=1

Review of Hot Flash Management in Patients With Prostate ... Hormonal therapies appear most effective for ameliorating VMS in men with prostate cancer experiencing bothersome hot flashes. Transdermal estradiol has been ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06957691?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Astellas%20Pharma%20US,%20Inc.%22)&viewType=Table&rank=1

Study Details | NCT06957691 | Proof-of-Concept Trial to ... The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen ...