Can a menopause drug cool hot flashes in prostate cancer patients?

NCT ID NCT07783282

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This study looks at whether a drug called fezolinetant, used for hot flashes, is processed differently in men with prostate cancer who are taking hormone therapy. It compares blood levels of fezolinetant in men on different hormone drugs (enzalutamide, apalutamide, or bicalutamide) versus healthy men. The goal is to understand how these hormone therapies might affect fezolinetant, which could help manage hot flashes—a common side effect of prostate cancer treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fezolinetant
What this could lead to
If fezolinetant works well with hormone therapy, it could offer a new way to ease hot flashes in men undergoing prostate cancer treatment.
What could go wrong
This is an early-phase study focused on drug levels, not yet on effectiveness. Results may not lead to a proven treatment, and side effects are still being assessed.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 56 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

50 to 75 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Participant is born male, inclusive of all gender ideologies. * Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 30 days after final fezolinetant administration. * Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 30 days after final study intervention administration. * Male participant must not donate sperm during the treatment period and for 30 days after final study intervention administration. * Participant agrees not to participate in another interventional study while participating in the present study. * Participant has a body mass index (BMI) range of 18.5 to 30.0 kg/m\^2 inclusive and weighs at least 50 kg at screening. Inclusion Criteria for Participants with Prostate Cancer: * Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate. * Participant must be receiving concurrent gonadotropin-releasing hormone (GnRH) agonist or antagonist therapy for a minimum of 3 months prior to study intervention on day 1 and be planning to continue on the therapy for the duration of the study. * Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening. * Participant is receiving concurrent and stable enzalutamide, apalutamide or bicalutamide for at least 3 months prior to study intervention on day 1, which must be continued throughout the study. * Participant has at least 6-month life expectancy. Inclusion Criteria for Healthy Participants: * Participant is healthy and has no clinically significant medical conditions based on the physical examination, electrocardiograms (ECGs) and protocol-defined clinical laboratory tests at screening or on day -1. Exclusion Criteria: * Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 2 days) after the last dose of study drug administration or end-of-study visit (ESV), whichever is longer. * Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1. * Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual (American Psychiatric Association), Fifth Edition (DSM-5) criteria within 2 years before screening. * Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome. * Participant has a gastrointestinal disorder affecting absorption. * Participant has present exposure or history of participation in a study of the study intervention (fezolinetant) or previous exposure to fezolinetant within 28 days prior to day -1. * Participant has received any investigational therapy within 90 days or 5 half-lives, whichever is longer, prior to screening * Participant tests positive for alcohol at screening or on day -1. * Participant has a positive serology test for hepatitis A virus (HAV) antibodies (immunoglobulin M (IgM)), hepatitis B (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening. * Participant tests positive for drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids) at screening or on day -1. * Participant has a positive result for Severe Acute Respiratory Syndrome Coronavirus-2 (novel coronavirus causing COVID-19 disease) (SARS-CoV-2) test at screening or on day -1. * Participant has creatinine \> 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2 using the Modification of Diet in Renal Disease formula at the screening visit. * Participant has active liver disease, jaundice, or elevated liver aminotransferase (ATs) (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total bilirubin (TBL) or direct bilirubin (DBL), or elevated alkaline phosphatase (ALP) at screening. A participant with mildly elevated ALT or AST up to \< 1.5 x ULN can be enrolled if TBL and DBL are normal. Participant with mildly elevated ALP (up to \< 1.5 x ULN) can be enrolled if cholestatic liver disease is excluded and no cause other than fatty liver is diagnosed. Participant with Gilbert's syndrome with elevated TBL may be enrolled as long as DBL, hemoglobin and reticulocytes are normal. * Participant has any condition which makes the participant unsuitable for study participation. * Participant regularly consumes \> 200 mg of caffeine per day. * Participant has smoked, used tobacco-containing products or nicotine or nicotine-containing products (e.g., electronic vapes) within 6 months prior to screening or the participant tests positive for cotinine at screening or day -1. * Participant has had significant blood loss, donated \>/=1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days. * Participant has a history of consuming \> 10 units of alcoholic beverages per week within 3 months prior to screening (note: 1 unit = 350 mL of beer, 150 mL of wine, 45 mL of spirits/hard liquor). * Participant has used any drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine, opiates and cannabinoids) within 3 months prior to day -1. Exclusion Criteria for Participants with Prostate Cancer: * Participant has a history of malignancy within 2 years before screening except for prostate cancer. Exception: squamous and basal cell carcinoma of the skin, or other malignancy that is considered cured with minimal risk of recurrence are allowed, upon agreement by the sponsor's medical monitor. * Participant has had surgery or chemotherapy treatment, immunotherapy or other targeted therapy for prostate cancer within the last 3 months prior to signing informed consent. Radiotherapy is allowed. * Participant plans to initiate treatment with chemotherapy during the study. * Participant has a medical condition or chronic disease (including history of neurological \[including cognitive\], hepatic, renal, cardiovascular, gastrointestinal, pulmonary \[e.g., moderate asthma\]) or malignancy that could confound interpretation of the study outcome. * Participant has known metastases in the liver or any hepatic disorder that could affect drug metabolism deemed clinically significant. * Participant uses a prohibited therapy or is not willing to wash out such drugs. * Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) within 28 days prior to day -1. * Participant uses any concomitant medication that is an inhibitor of CYP1A2, CYP2C9 or CYP2C19 within 7 days prior to day -1. Exclusion Criteria for Healthy Participants: * Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy. * Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 28 days prior to study intervention administration (i.e., 45 mg fezolinetant) on day 1, except for occasional use of acetaminophen or paracetamol (up to 2 g/day) and topical dermatological products (including corticosteroid products). * Participant has a mean pulse \< 40 or \> 90 bpm; mean systolic blood pressure (SBP) \> 160 mmHg; mean diastolic blood pressure (DBP) \> 100 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken. * Participant has a mean corrected QT interval by Fridericia's correction formula (QTcF) of \> 450 msec on day -1. * Participant is an employee of Astellas, the study-related contract research organization (CROs) or the clinical unit.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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