NCT06957691 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
| NCT ID | NCT06957691 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shehzad Basaria, M.D. |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-14 |
| Primary Completion | 2028-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-01-14 with a primary completion date of 2028-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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 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 * 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.
Contact & Investigator
Shehzad S Basaria, MD
PRINCIPAL INVESTIGATOR
Brigham and Women's Hospital
Frequently Asked Questions
Who can join the NCT06957691 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06957691 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06957691 currently recruiting?
Yes, NCT06957691 is actively recruiting participants. Contact the research team at eborwick@bwh.harvard.edu for enrollment information.
Where is the NCT06957691 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06957691 clinical trial?
NCT06957691 is sponsored by Shehzad Basaria, M.D.. The principal investigator is Shehzad S Basaria, MD at Brigham and Women's Hospital. The trial plans to enroll 60 participants.
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