Health Trials

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

ConditionsProstate CancerProstate Cancer (Adenocarcinoma)Prostate Cancer Metastatic DiseaseProstate Cancer RecurrentProstate CarcinomaProstate NeoplasmProstate AdenocarcinomaProstate Cancer With Bone MetastasisVasomotor DisturbanceVasomotor SymptomsVasomotor Symptoms (VMS)Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and MenVasomotor Symptoms; Hot FlashesAndrogen Deprivation TherapyAndrogen Ablative Therapy of Advanced Hormone-dependent Prostate CarcinomaAndrogen-deprivation TherapyHot FlashesHot FlushesHot Flushes and/or Sweats
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age40+
SponsorShehzad Basaria, M.D.

About this 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

Eligibility criteria

Qualifiers

Male sex

Age 40 years and older

Diagnosis of prostate cancer

Androgen deprivation therapy

Disqualifiers

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

Trial design

Treatments tested in this trial

  • fezolinetant - reference formulation
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1
Brigham and Women's Hospital02115, BostonMassachusetts, United States

Sponsors and collaborators

Shehzad Basaria, M.D.

Lead sponsor

Brigham and Women's Hospital

Sponsor institution

Astellas Pharma US, Inc.

Collaborator

Source ClinicalTrials.gov