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Tests treatment safety and results for Prostate Cancer
Official title 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
ClinicalTrials.gov ID: NCT06957691
What this study is testing
What is fezolinetant - reference formulation?
fezolinetant - reference formulation is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.