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

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
• Prostate Neoplasm
• Prostate Adenocarcinoma
• Prostate Cancer With Bone Metastasis
• Vasomotor Disturbance
• Vasomotor Symptoms
• Vasomotor Symptoms (VMS)
• Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
• Vasomotor Symptoms; Hot Flashes
• Androgen Deprivation Therapy
• Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
• Androgen-deprivation Therapy
• Hot Flashes
• Hot Flushes
• Hot Flushes and/or Sweats

Interventions

DRUG

fezolinetant - reference formulation

Daily oral administration of fezolinetant at a dose of 45 mg

DRUG

Placebo

Daily oral administration of placebo

Sponsors & Collaborators

• Astellas Pharma US, Inc.

  collaborator INDUSTRY

• Shehzad Basaria, M.D.

  lead OTHER

Principal Investigators

• Shehzad S Basaria, MD · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-14

Primary Completion

2028-08-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations