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New hope for men battling hot flashes from prostate cancer treatment

NCT ID NCT06957691

Symptom relief Sponsor: Shehzad Basaria, M.D. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times

Summary

This study tests a drug called fezolinetant to see if it can reduce hot flashes in men with prostate cancer who are on hormone therapy (androgen deprivation therapy). About 60 men will take either the drug or a placebo daily for 4 weeks. Researchers will track hot flash frequency, severity, and impact on quality of life, while also checking for liver safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male sex * 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 * Ability to sign the inform consent * Willing to use reliable methods of contraception if partner is of childbearing age * Ability to record hot flashes electronically Exclusion Criteria: * Use of abiraterone acetate * Use of docetaxel and other chemotherapeutic agents * Liver cirrhosis * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of normal * Total bilirubin above the upper limit of normal * Glomerular filtration rate \< 30 mL/min * Use of selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, sedatives, or hypnotics if prescribed for the treatment of hot flashes * Use of over-the-counter hormonal agents or herbal compounds * Current use of CYP1A2 inhibitors * Ingestion of alcohol within 2 weeks prior to the baseline visit * Inability to abstain from alcohol use during the study period.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma hormone-resistant prostate carcinoma Hot Flashes metastatic prostate carcinoma multiple endocrine neoplasia type 1 prostate adenocarcinoma prostate cancer prostate carcinoma prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Androgen ablative therapy of advanced hormone-dependent prostate carcinoma Androgen deprivation therapy Hot flashes Hot flushes Hot flushes and/or sweats Prostate adenocarcinoma Prostate cancer Prostate cancer (adenocarcinoma) Prostate cancer metastatic disease Prostate cancer recurrent Prostate cancer with bone metastasis Prostate carcinoma Prostate neoplasm Vasomotor disturbance Vasomotor symptoms Vasomotor symptoms (VMS) Vasomotor symptoms as A sex hormone-dependent disorder in women and men Vasomotor symptoms; hot flashes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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