Recruiting
Phase 2

Fezolinetant

Sponsor:

Shehzad Basaria, M.D.

Code:

NCT06957691

Conditions

Prostate Cancer

Prostate Cancer (Adenocarcinoma)

Prostate Cancer Metastatic Disease

Prostate Cancer Recurrent

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

fezolinetant - reference formulation

Placebo

Study Details

Brief summary:

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

Conditions

Prostate Cancer

Prostate Cancer (Adenocarcinoma)

Prostate Cancer Metastatic Disease

Prostate Cancer Recurrent

Prostate Carcinoma

Study ID

NCT06957691

Start date

Jan 14, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fezolinetant

Daily oral administration at a dose of 45 mg

placebo comparator: Placebo

Daily oral administration

Interventions

fezolinetant - reference formulation

Daily oral administration of fezolinetant at a dose of 45 mg

Placebo

Daily oral administration of placebo

Primary outcome measure

  • 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. ]
  • Hepatic safety, as assessed by measuring liver function tests [ Time Frame: From baseline to the end of treatment at 4 weeks. ]

Central Contacts and Locations

Central contacts

Caroline Veteri

617-525-8407cveteri@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Caroline Veteri

617-525-8407cveteri@bwh.harvard.edu

Principal Investigator:

Shehzad Basaria, MD

More Information

Sponsor

Shehzad Basaria, M.D.

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Androgen Deprivation Therapy
  • Hot Flashes
  • Hot Flushes
  • Prostate Cancer
  • Vasomotor Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shehzad Basaria, M.D. on 2026-08-17.