Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT)

August 13, 2026 updated by: Shehzad Basaria, M.D.

Proof-of-Concept Trial to Assess the Efficacy and Safety of Fezolinetant in Improving Vasomotor Symptoms in Men With Prostate Cancer Undergoing Androgen Deprivation Therapy (Fezo-ADT Trial)

The goal of this clinical trial is to learn if fezolinetant can treat hot flashes (vasomotor symptoms) in men with prostate cancer undergoing androgen deprivation therapy.

The main questions it aims to answer are:

  • Does fezolinetant improve the frequency and severity of hot flashes?
  • Does fezolinetant cause any harm to the liver?
  • Does fezolinetant improve quality of life, sleep quality, fatigue, mood, sexual function, and metabolic parameters?

Researchers will compare how people respond to fezolinetant versus a placebo, which does not contain any active medicine.

Participants will:

  • Take fezolinetant or a placebo every day for 4 weeks
  • Visit the clinic once every 2 weeks for checkups and tests
  • Keep a diary of the number of times and intensity that they experience hot flashes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate cancer is the most common type of cancer in men. At the time of initial diagnosis, most men have disease that is confined to the prostate and are typically managed through surveillance or local treatments, such as prostatectomy or radiation therapy. Since the prostate relies on androgens (male hormones), androgen deprivation therapy is the primary treatment for patients with locally advanced, recurrent, or metastatic prostate cancer.

Androgen deprivation therapy involves suppressing the production of androgens in men, which can be achieved through orchiectomy (removal of the testes) or medications like gonadotropin-releasing hormone agonists or antagonists that lower serum testosterone levels to a castrate range (less than 20 ng/dL). In men, 95% of serum estrogen comes from the aromatization of testosterone. Consequently, androgen deprivation not only leads to androgen deficiency but also results in near-absolute estrogen deficiency. The absence of sex hormones in these patients can cause numerous adverse effects, including sexual dysfunction, and loss of muscle and bone. Among these side effects, vasomotor symptoms (such as hot flashes) are particularly debilitating. These symptoms are characterized by sudden feelings of intense heat that spread throughout the body, prompting the activation of heat-dissipation mechanisms to lower body temperature.

Hot flashes are reported by 70-80% of men undergoing androgen deprivation therapy, typically beginning a few weeks after treatment starts, with most men experiencing more than five episodes daily. These vasomotor symptoms significantly affect the patient's quality of life, sleep quality, concentration, and overall productivity. Despite the burden they impose, effective treatments for hot flashes in men undergoing androgen deprivation therapy are still lacking.

The introduction of neurokinin 3 (NK3) receptor antagonists has brought hope to this area. Fezolinetant is a selective NK3 receptor antagonist that has recently been approved for treating moderate to severe vasomotor symptoms in menopausal women. Given that the underlying cause of vasomotor symptoms in both menopausal women and men on androgen deprivation therapy stems from estrogen deficiency, fezolinetant offers an opportunity to assess its efficacy and safety for male patients.

No previous studies have evaluated the effectiveness of NK3 receptor antagonists on vasomotor symptoms in men undergoing androgen deprivation therapy for prostate cancer. Since prostate cancer is the most prevalent solid tumor in men and vasomotor symptoms are common, distressing, and highly burdensome, a trial demonstrating the safety and efficacy of fezolinetant could provide clinicians and patients with a novel, effective, safe, and easy-to-administer treatment that has the potential to transform care for these patients.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Shehzad Basaria, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fezolinetant
Daily oral administration at a dose of 45 mg
Drug: fezolinetant - reference formulation
Daily oral administration of fezolinetant at a dose of 45 mg
Other Names:
  • Veozah
Placebo Comparator: Placebo
Daily oral administration
Drug: Placebo
Daily oral administration of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Frequency of Vasomotor Symptoms Through Daily Hot Flash Diary from Baseline to 4 Weeks
Time Frame: From baseline to the end of treatment at 4 weeks.
Participants achieved a response if they had a significant decrease in scores in the hot flash diary.
From baseline to the end of treatment at 4 weeks.
Hepatic safety, as assessed by measuring liver function tests
Time Frame: From baseline to the end of treatment at 4 weeks.
Fezolinetant was considered safe if liver function tests did not change significantly.
From baseline to the end of treatment at 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality-of-life symptoms related to hot flashes, as assessed using the Hot Flash-Related Daily Interference Scale
Time Frame: From baseline to the end of treatment at 4 weeks.
The Hot Flash-Related Daily Interference Scale scores range from 0 to 10, with higher scores meaning a worse outcome. Participants improved if they had a significant decrease in their Hot Flash-Related Daily Interference Scale scores.
From baseline to the end of treatment at 4 weeks.
Change in overall quality of life, as assessed using the Short Form-36 questionnaire
Time Frame: From baseline to the end of treatment at 4 weeks.
The Short Form-36 scores range from 0 to 100, with higher scores meaning a better outcome. Participants improved if they had a significant increase in their Short Form-36 scores.
From baseline to the end of treatment at 4 weeks.
Change in sleep quality, as assessed using the Patient-Reported Outcomes Measurement Information System Sleep Disturbance questionnaire
Time Frame: From baseline to the end of treatment at 4 weeks.
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance scores range from about 30 to 80, with lower scores meaning better outcome. Patients improved if they had a significant decrease in Patient-Reported Outcomes Measurement Information System Sleep Disturbance scores.
From baseline to the end of treatment at 4 weeks.
Change in mood, as assessed using the Positive and Negative Affect Schedule questionnaire
Time Frame: From baseline to the end of treatment at 4 weeks.
The Positive and Negative Affect Schedule questionnaire measures two dimensions of mood, Positive Affect and Negative Affect. The scores in each dimension range from 10 to 50. A higher score in the Positive Affect dimension means a better outcome, and a higher score in the Negative Affect dimension means a worse outcome. Participants improved if they had a significant increase in the Positive Affect dimension scores and a significant decrease in the Negative Affect dimension scores in the Positive and Negative Affect Schedule questionnaire.
From baseline to the end of treatment at 4 weeks.
Change in sexual function, as assessed using the Sexual Arousal, Interest and Drive questionnaire
Time Frame: From baseline to the end of treatment at 4 weeks.
The Sexual Arousal, Interest and Drive questionnaire scores range from 0 to 100, with higher scores meaning better outcome. Participants improved if they had a significant increase in Sexual Arousal, Interest and Drive scores.
From baseline to the end of treatment at 4 weeks.
Change in inflammatory status, as assessed by measuring high-sensitivity C-reactive protein (hsCRP) levels
Time Frame: From baseline to the end of treatment at 4 weeks.
Participants improved if they had a significant decrease in high-sensitivity C-reactive protein (hsCRP) levels.
From baseline to the end of treatment at 4 weeks.
Change in fatigue, as assessed using the using the Hypogonadism Energy Diary questionnaire
Time Frame: From baseline to the end of treatment at 4 weeks.
The Hypogonadism Energy Diary scores range from 0 to 100, with higher scores meaning better outcome. Participants improved if they had a significant increase in Hypogonadism Energy Diary scores.
From baseline to the end of treatment at 4 weeks.
Change in fatigue, as assessed using the using the Functional Assessment of Chronic Illness Therapy - Fatigue questionnaire
Time Frame: From baseline to the end of treatment at 4 weeks.
The Functional Assessment of Chronic Illness Therapy - Fatigue scores range from 0 to 160, with higher scores meaning better outcome. Participants improved if they had a significant increase in Functional Assessment of Chronic Illness Therapy - Fatigue scores.
From baseline to the end of treatment at 4 weeks.
Change in fasting glucose level
Time Frame: From baseline to the end of treatment at 4 weeks.
Participants improved if they had a significant decrease in fasting glucose level.
From baseline to the end of treatment at 4 weeks.
Change in glycated hemoglobin (HbA1c) level
Time Frame: From baseline to the end of treatment at 4 weeks.
Participants improved if they had a significant decrease in glycated hemoglobin (HbA1c) level.
From baseline to the end of treatment at 4 weeks.
Change in fasting lipid levels
Time Frame: From baseline to the end of treatment at 4 weeks.
Participants improved if they had a significant decrease in fasting lipid levels.
From baseline to the end of treatment at 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shehzad Basaria, M.D.

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Shehzad S Basaria, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 13, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR1000264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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