[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590857":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":48,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Vermont","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"fezolinetant treatment","EXPERIMENTAL","Adult male patients with prostate cancer experiencing hot flashes due to androgen deprivation therapy will be treated with fezolinetant. Hot flashes will be monitored to assess improvements resulting from the investigational drug",[13],"Drug: Fezolinetant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Fezolinetant","Participants will receive fezolinetant for 28 days at FDA approved dosing and schedule of 45 mg po (per os\u002Fby mouth) once daily for treatment of hot flashes in menopausal women.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Steven Ades, MD, MSc","CONTACT","802-656-2021","steven.ades@med.uvm.edu",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"University of Vermont Medical Center","RECRUITING","Burlington","Vermont","05401","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-73.21207,44.47588,{"lat":40,"lon":39},[43,45],{"name":23,"role":24,"phone":44,"phoneExt":20,"email":26},"(802) 656-2021",{"name":46,"role":47,"phone":20,"phoneExt":20,"email":20},"Steven Ades, MD MSc","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":29,"oldNameTitle":20,"oldOrganization":20},"Steven Ades","Medical Oncologist, Professor of Medicine, Medical Director","100590857","phase-2-fezolinetant-for-treating-hot-flashes-in-men-with-prostate-cancer-100590857",false,"NCT06972875","Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer","Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study","FLASH","Inclusion Criteria:\n\nAge ≥ 18 years Men who are currently receiving Androgen Deprivation Therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). Men receiving Androgen Receptor Pathway Inhibitors (ARPI) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible.\n\nPatients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Additional ARPI agents (e.g. abiraterone or enzalutamide) are allowed to be added during the Extension Phase of the trial, but not during the Treatment Phase.\n\nPatients receiving radiation therapy during the study period are eligible. An eligible patient must have bothersome hot flashes for ≥ 7 days prior to consent, resulting in an average of four or more hot flashes per day of sufficient severity to cause the patient to seek therapeutic intervention.\n\nLife Expectancy of 6 months or greater. Language: In order to complete the mandatory participant-completed measures, participants must be able to speak and read English.\n\nExclusion Criteria:\n\nCurrent or future planned use of any of the following agents during the study period: drugs that are not FDA approved for use in humans, any drug with category X interactions with fezolinetant; androgens, estrogens, progesterone analogs, or complementary\u002Falternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration. Stable dosing (≥ 1 month) of gabapentin, cholinergic agonists, cholinesterase inhibitors for other indications is permitted.\n\nHistory of cirrhosis Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 X ULN or total bilirubin \\> ULN eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 based on reported MDRD estimate. Current use of CYP1A2 inhibitors (fezolinetant is a substrate of CYP1A2).","MALE","18 Years",{"count":62,"type":63},32,"ESTIMATED","INTERVENTIONAL",[66],"PHASE2","This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.",[69,70],"Prostate CA","Androgen Deprivation Therapy",[72,73,74,75],"prostate cancer","androgen deprivation therapy","hot flash","fezolinetant","2026-02-02",{"date":78,"type":79},"2026-02-05","ACTUAL",{"date":81,"type":79},"2025-12-18",{"date":83,"type":63},"2027-02",{"name":5,"class":6},1]