[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464434":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":50,"locations":56,"responsibleParty":157,"collaborators":159,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":167,"sex":173,"minAge":174,"maxAge":31,"enrollmentInfo":175,"targetDuration":31,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":59,"whyStopped":31,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"CHU de Quebec-Universite Laval","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bicalutamide","EXPERIMENTAL","Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral bicalutamide for 90 days (in cohort A and cohort B)",[13],"Drug: Bicalutamide",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","ACTIVE_COMPARATOR","cohort A: Induction intravesical Bacille Calmette-Guérin treatment\n\ncohort B: Induction intravesical Bacille Calmette-Guérin treatment with 150 mg daily oral placebo for 90 days",[19],"Biological: Control Arm",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Induction intravesical BCG with bicalutamide 150 mg for 90 days",[9],[26],"Nonsteroidal antiandrogen",{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"BIOLOGICAL","Induction BCG",[15],null,[33,37,41,44,47],{"name":34,"affiliation":35,"role":36},"Paul Toren, MD,PhD,FRCSC","CHU de Québec-Université Laval","STUDY_CHAIR",{"name":38,"affiliation":39,"role":40},"Wassim Kassouf, MDCM,FRCSC","McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":40},"Melissa Huynh, MD,MPH,FRCSC","London Health Sciences Centre, Victoria Hospital",{"name":45,"affiliation":46,"role":40},"Jean-Baptiste Lattouf, MD,FRCSC","Centre Hospitalier Universitaire de Montréal (CHUM)",{"name":48,"affiliation":49,"role":40},"Girish Kulkarni, BSc, MD, PhD, FRCSC","The Princess Margaret Cancer Foundation",[51],{"name":34,"role":52,"phone":53,"phoneExt":54,"email":55},"CONTACT","418-525-4444","17064","paul.toren@crchudequebec.ulaval.ca",[57,76,88,103,115,126,143],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"London Health Sciences Centre","RECRUITING","London","Ontario","N6A 5W9","Canada","CA",{"type":66,"coordinates":67},"Point",[68,69],-81.23304,42.98339,{"lat":69,"lon":68},[72],{"name":73,"role":52,"phone":74,"phoneExt":31,"email":75},"Melissa Huynh, MD","519-685-8451","Melissa.Huynh@LHSC.on.ca",{"facility":77,"status":59,"city":78,"state":61,"zip":79,"country":63,"countryCode":64,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"University Health Network, Princess Margaret Cancer Centre","Toronto","M5G 2C1",{"type":66,"coordinates":81},[82,83],-79.39864,43.70643,{"lat":83,"lon":82},[86],{"name":48,"role":52,"phone":31,"phoneExt":31,"email":87},"Girish.kulkarni@uhn.ca",{"facility":89,"status":59,"city":90,"state":91,"zip":92,"country":63,"countryCode":64,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Centre intégré de santé et services sociaux de Chaudière Appalaches","Lévis","Quebec","G6V3Z1",{"type":66,"coordinates":94},[95,96],-71.17793,46.80326,{"lat":96,"lon":95},[99],{"name":100,"role":52,"phone":101,"phoneExt":31,"email":102},"Matthieu Gratton, MD","(418) 835-7121","matthieu.gratton.med@sss.gouv.qc.ca",{"facility":104,"status":59,"city":105,"state":91,"zip":106,"country":63,"countryCode":64,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Centre Hospitalier de l'Université De Montréal_CHUM","Montreal","H2X 3E4",{"type":66,"coordinates":108},[109,110],-73.58781,45.50884,{"lat":110,"lon":109},[113],{"name":114,"role":52,"phone":31,"phoneExt":31,"email":31},"Jean-Baptiste Lattouf, MD",{"facility":116,"status":59,"city":105,"state":91,"zip":117,"country":63,"countryCode":64,"cosmosGeoPoint":118,"geoPoint":120,"contacts":121},"McGill University Health Centre_CUSM","H4A 3J1",{"type":66,"coordinates":119},[109,110],{"lat":110,"lon":109},[122],{"name":123,"role":52,"phone":124,"phoneExt":31,"email":125},"Wassim Kassouf, MDCM","(514) 934-8246","wassim.kassouf.med@ssss.gouv.qc.ca",{"facility":35,"status":59,"city":127,"state":91,"zip":128,"country":63,"countryCode":64,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Québec","G1G 5X1",{"type":66,"coordinates":130},[131,132],-71.21454,46.81228,{"lat":132,"lon":131},[135,138],{"name":136,"role":52,"phone":53,"phoneExt":54,"email":137},"Paul Toren, MD","Paul.toren@crchudequebec.ulaval.ca",{"name":139,"role":52,"phone":140,"phoneExt":141,"email":142},"Typhaine Gris, PhD","418 525-4444","20417","typhaine.gris@crchudequebec.ulaval.ca",{"facility":144,"status":59,"city":145,"state":91,"zip":146,"country":63,"countryCode":64,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"CIUSSS de l'Estrie - CHUS","Sherbrooke","J1H 5H3",{"type":66,"coordinates":148},[149,150],-71.89908,45.40008,{"lat":150,"lon":149},[153],{"name":154,"role":52,"phone":155,"phoneExt":31,"email":156},"Patrick Richard, MD","819-346-1110","Patrick.Richard@usherbrooke.ca",{"type":158,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[160,163],{"name":161,"class":162},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":164,"class":6},"Cancer Research Society","100464434","phase-2-a-phase-ii-trial-of-bicalutamide-in-patients-receiving-intravesical-bcg-for-non-muscle-invasive-bladder-cancer-100464434",false,"NCT05327647","A Phase II Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer","A Phase II Randomized Trial of Bicalutamide in Patients Receiving Intravesical BCG for Non-muscle Invasive Bladder Cancer","BicaBCa","Inclusion Criteria:\n\n1. Males, age 18 or greater.\n2. Patients with histologically confirmed non-muscle invasive urothelial carcinoma.\n3. Patients have been recommended for a course of intravesical BCG induction treatment by their urologist\n4. Patients who received gemcitabine, epirubicin or mitomycin C instillations immediately post-operatively will be eligible for enrollment.\n5. Patients with partners of child-bearing potential must agree to 2 acceptable forms of birth control and be continued for at least 3 months after study drug is discontinued.\n\nExclusion Criteria:\n\n1. Patients who have received induction BCG therapy within the last 5 years will be ineligible for enrolment.\n2. Patients with a history of myocardial infarction or hospital admission for heart failure within the previous 12 months or who have unstable cardiovascular status will be ineligible for enrolment.\n3. Patients who have uncontrolled hypertension (for our purposes, defined as those having a systolic blood pressure \\> 160 documented on 2 occasions despite appropriate medical therapy) will similarly be ineligible.\n4. Patients with a history of liver disease whose hepatic enzymes, alkaline phosphatase or bilirubin are greater than twice the upper limit of normal will be ineligible.\n5. Patients with clinical hypogonadism, those on androgen replacement therapy, or those with prostate cancer or other diseases treated with systemic hormonal therapy will be ineligible for study enrolment. Patients receiving 5ARIs will not be excluded.\n6. Patients who have cancer treatment ongoing or planned in the near future which can be anticipated to decrease their 2-year survival or BCa treatment plan will be ineligible.\n7. Patients taking an investigational drug within 2 weeks of enrolment into this study will be ineligible.\n8. Patients receiving or planning to receive coumadin therapy will be ineligible.","MALE","18 Years",{"count":176,"type":177},160,"ESTIMATED","INTERVENTIONAL",[180],"PHASE2","This is a phase II randomized controlled clinical trial comparing standard induction BCG versus bicalutamide and standard induction BCG among patients with non-muscle invasive bladder cancer.",[183],"Non-Muscle Invasive Bladder Cancer",[9,185,186],"BCG instillation","Placebo","2025-12-17",{"date":189,"type":190},"2025-12-18","ACTUAL",{"date":192,"type":190},"2022-06-23",{"date":194,"type":177},"2026-12-31",{"name":5,"class":6},7]