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
Recruiting
Phase 2
Interventional Study
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
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 40 and older
- Sex
- Male
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Shehzad Basaria, M.D. · Other
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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, fati…
Trial Locations
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Eligibility Criteria
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 m…
Contacts