[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636634":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":47,"studyPopulation":37,"armGroups":48,"interventions":61,"overallOfficials":69,"centralContacts":73,"locations":79,"responsibleParty":96,"collaborators":37,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":37,"eligibilityCriteria":105,"healthyVolunteers":101,"sex":106,"minAge":107,"maxAge":37,"enrollmentInfo":108,"targetDuration":37,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":37,"overallStatus":82,"whyStopped":37,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":37},[9,13],{"measure":10,"description":11,"timeFrame":12},"Hot flush severity","Participants will document daily VMS episodes categorised as mild, moderate, severe, or very severe.","Baseline, week 3, week 7 and week 11",{"measure":14,"description":15,"timeFrame":12},"Daily hot flush score","Calculatedusing the formula: (1 × mild) + (2 × moderate) + (3 × severe) + (4 × very severe) divided by the number of diary days completed in that week.",[17,21,24,27,30,33],{"measure":18,"description":19,"timeFrame":20},"Patient reported quality of life by QLQ-C30","Quality of life measured by QLQ-C30, score 0-100, the higher the score the better in quality of life","Baseline, week 4, week 8 and week 12",{"measure":22,"description":23,"timeFrame":20},"Sleep Quality","By Pittsburgh Sleep Quality Index (PSQI). PSQI is scored by summing seven component scores (0-3 each) to produce a global score ranging from 0 to 21. A total score greater than 5 indicates poor sleep quality.",{"measure":25,"description":26,"timeFrame":20},"Mood status","By Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item screening tool used to measure depression severity, with a total score ranging from 0 to 27. Scores are interpreted as: 0-4 (none-minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe).",{"measure":28,"description":29,"timeFrame":20},"Lower urinary tract symptoms (LUTS)","Urinary symptoms measured by IPSS score, score ranging from 0-35 (the higher the worse)",{"measure":31,"description":32,"timeFrame":20},"Patient reported quality of life by Hot Flash-Related Daily Interference Scale (HFRDIS)","HFRDIS) is a 10-item, self-report tool measuring how vasomotor symptoms (hot flashes) impact daily life over the past week. Scores are summed across 10 items on a 0-10 scale (total 0-100), with higher scores indicating greater interference. Validated cut-points for severity are mild (0-3.9), moderate (4-6.9), and severe (7-10)",{"measure":34,"description":35,"timeFrame":36},"Adverse Events","CTCAE rectal toxicity, Grade 1-5 for any rectal toxicity, the higher the score the more severe the toxicity","Baseline, Week 4, Week 8 and Week 12",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":44},"DOUBLE",[45,46],"PARTICIPANT","INVESTIGATOR","Participants will be randomized in a 1:1 manner to receive fezolinetant 45 mg or placebo orally once daily for 12 weeks in total, with the primary and secondary outcomes being assessed at week 4, 8 and 12 with standardized questionnaires, symptom diaries, blood taking, and clinical history taking in the clinic setting.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Treatment Arm","EXPERIMENTAL","Fezolinetant 45 mg orally once daily for 12 weeks.",[54],"Drug: Fezolinetant",{"label":56,"type":57,"description":58,"interventionNames":59},"Placebo Arm","PLACEBO_COMPARATOR","Placebo orally once daily for 12 weeks.",[60],"Drug: Placebo",[62,66],{"type":63,"name":64,"description":52,"armGroupLabels":65,"otherNames":37},"DRUG","Fezolinetant",[50],{"type":63,"name":67,"description":58,"armGroupLabels":68,"otherNames":37},"Placebo",[56],[70],{"name":71,"affiliation":5,"role":72},"Chi Fai NG, MD","PRINCIPAL_INVESTIGATOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":37,"email":78},"Alex LIU, RCSEd, MBBS","CONTACT","35052625","alexliu@surgery.cuhk.edu.hk",[80],{"facility":81,"status":82,"city":83,"state":37,"zip":37,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Prince of Wales Hospital","RECRUITING","Shatin","Hong Kong","HK",{"type":87,"coordinates":88},"Point",[89,90],114.18333,22.38333,{"lat":90,"lon":89},[93],{"name":71,"role":76,"phone":94,"phoneExt":37,"email":95},"3505 2625","ngcf@surgery.cuhk.edu.hk",{"type":72,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"NG Chi Fai","Professor","100636634","phase-2-a-trial-on-fezolinetant-for-vasomotor-symptoms-in-men-receiving-androgen-deprivation-therapy-adt-100636634",false,"NCT07568236","A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)","A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)","Inclusion Criteria:\n\n1. Patients aged at least 18 years old on the index date\n2. Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease\n3. Karnofsky index score of 70% or more\n4. Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline\n5. Baseline daily hot flush score ≥4\n\nExclusion Criteria:\n\n1. Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine\n2. Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.\n3. Active liver disease including:\n\n   \\- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT \u002F AST - abnormal INR\n4. Severe (eGFR 15 to less than 30 mL\u002Fmin\u002F1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL\u002Fmin\u002F1.73 m2)","MALE","18 Years",{"count":109,"type":110},54,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.",[116,117],"Vasomotor Symptoms","Prostate Cancer","2026-10-04",{"date":120,"type":121},"2026-10-07","ACTUAL",{"date":123,"type":121},"2026-10-05",{"date":125,"type":110},"2028-03-31",{"name":5,"class":6},1]