[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100253108":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":13,"interventions":13,"overallOfficials":13,"centralContacts":19,"locations":26,"responsibleParty":150,"collaborators":13,"id":154,"slug":13,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":13,"eligibilityCriteria":158,"healthyVolunteers":155,"sex":159,"minAge":160,"maxAge":13,"enrollmentInfo":161,"targetDuration":13,"studyType":164,"phases":13,"briefSummary":165,"conditions":166,"keywords":13,"overallStatus":29,"whyStopped":13,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Number of patients with biochemical failure showing coexistence of PTEN and TMPRSS2-ERG gene fusion.","Biopsy samples of patients treated for high risk prostate cancer with radical radiation and hormonal therapy (LHRH) who have either clinical progression or 3-year hormonal refractory free survival will be tested to evaluate the predictive value of the coexistence of TMPRSS2-ERG gene fusion and the PTEN deletion. The results between the two groups will be compared to see if either DNA changes are an indicator of LHRH refractoriness","recruitment over 4 years",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"CASE_ONLY","PROSPECTIVE","The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.\n\nPatients in this study will be treated with standard hormonal treatment. Patients will remain on treatment regardless of rising PSA. PSA, other systemic therapy maybe added and the patients with oligometastasis could be treated with radiation therapy; this would be at the discretion of the treating oncologist.\n\nThe primary endpoint of this study is to determine the predictive value of TMPRSS2-ERG gene fusion and PTEN in hormonal refractory free survival and clinical progression rate in three years. The secondary endpoints are to evaluate the relation between Gleason score and TMPRSS2-ERG gene fusion and PTEN independently and together, the relation between T stage and TMPRSS2-ERG gene fusion and PTEN independently and together, and to determine the association of these markers with overall survival.","The original slides of 208 patients with informed consent will be reviewed. Patients with and without markers under the investigation will be accrued into this study. The investigators at the treating institutions will submit paraffin-embedded tissue blocks from the original pre-treatment diagnostic prostatic biopsy, which will be reviewed to confirm the Gleason score and to record other histopathologic features, such as the extent of tumor in the biopsies, the number of positive biopsies, and mitotic index.",[20],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},"Ashley Feng, M.Sc.","CONTACT","514-340-8222","26510","yanqi.feng.ccomtl@ssss.gouv.qc.ca",[27,44,58,72,86,96,107,121,136],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"CIUSSS du Saguenay-Lac-St-Jean\u002FCSSS de Chicoutimi","RECRUITING","Chicoutimi","Quebec","G7H 5H6","Canada","CA",{"type":36,"coordinates":37},"Point",[38,39],-71.06369,48.41963,{"lat":39,"lon":38},[42],{"name":43,"role":22,"phone":13,"phoneExt":13,"email":13},"Hugo Villeneuve, MD",{"facility":45,"status":29,"city":46,"state":31,"zip":47,"country":33,"countryCode":34,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"CISSS de la Montérégie-Centre - Hôpital Charles-LeMoyne","Greenfield Park","J4V 2H1",{"type":36,"coordinates":49},[50,51],-73.46223,45.48649,{"lat":51,"lon":50},[54,56],{"name":55,"role":22,"phone":13,"phoneExt":13,"email":13},"Genevieve Bujold",{"name":57,"role":22,"phone":13,"phoneExt":13,"email":13},"Marjorie Jolicoeur, MD",{"facility":59,"status":29,"city":60,"state":31,"zip":61,"country":33,"countryCode":34,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"CISSS de Laval - Hôpital de la Cité-de-la-santé de Laval","Laval","H7M 3L9",{"type":36,"coordinates":63},[64,65],-73.692,45.56995,{"lat":65,"lon":64},[68,70],{"name":69,"role":22,"phone":13,"phoneExt":13,"email":13},"Solange Tremblay",{"name":71,"role":22,"phone":13,"phoneExt":13,"email":13},"Levon Igidbashian, MD",{"facility":73,"status":29,"city":74,"state":31,"zip":75,"country":33,"countryCode":34,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"CIUSSS de l'Est-de-l'Île-de-Montréal - Hôpital Maisonneuve-Rosemont","Montreal","H1T 2M4",{"type":36,"coordinates":77},[78,79],-73.58781,45.50884,{"lat":79,"lon":78},[82,84],{"name":83,"role":22,"phone":13,"phoneExt":13,"email":13},"Josée Abi-Saad",{"name":85,"role":22,"phone":13,"phoneExt":13,"email":13},"Peter Vavassis, MD",{"facility":87,"status":29,"city":74,"state":31,"zip":88,"country":33,"countryCode":34,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Jewish General Hospital, McGill University","H3T 1E2",{"type":36,"coordinates":90},[78,79],{"lat":79,"lon":78},[93,94],{"name":21,"role":22,"phone":23,"phoneExt":24,"email":25},{"name":95,"role":22,"phone":13,"phoneExt":13,"email":13},"Tamim Niazi, MD",{"facility":97,"status":29,"city":74,"state":31,"zip":98,"country":33,"countryCode":34,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"MUHC - Cedars Cancer Center","H4A 3J1",{"type":36,"coordinates":100},[78,79],{"lat":79,"lon":78},[103,105],{"name":104,"role":22,"phone":13,"phoneExt":13,"email":13},"Marianna Perna",{"name":106,"role":22,"phone":13,"phoneExt":13,"email":13},"Luis Souhami, MD",{"facility":108,"status":29,"city":109,"state":31,"zip":110,"country":33,"countryCode":34,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"CHU - L'Hôtel-Dieu de Québec","Québec","G1R 2J6",{"type":36,"coordinates":112},[113,114],-71.21454,46.81228,{"lat":114,"lon":113},[117,119],{"name":118,"role":22,"phone":13,"phoneExt":13,"email":13},"Josée Allard",{"name":120,"role":22,"phone":13,"phoneExt":13,"email":13},"André-Guy Martin, MD",{"facility":122,"status":123,"city":124,"state":31,"zip":125,"country":33,"countryCode":34,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"CIUSSS de l'Estrie - Hôpital Fleurimont","NOT_YET_RECRUITING","Sherbrooke","J1H 5N4",{"type":36,"coordinates":127},[128,129],-71.89908,45.40008,{"lat":129,"lon":128},[132,134],{"name":133,"role":22,"phone":13,"phoneExt":13,"email":13},"Sophie Couture",{"name":135,"role":22,"phone":13,"phoneExt":13,"email":13},"Abdenour Nabid, MD",{"facility":137,"status":29,"city":138,"state":31,"zip":139,"country":33,"countryCode":34,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"CIUSSS de la Mauricie-et-du-centre-du Quebec - Centre hospitalier régional de Trois-Rivières","Trois-Rivières","G8Z 3R9",{"type":36,"coordinates":141},[142,143],-72.5477,46.34515,{"lat":143,"lon":142},[146,148],{"name":147,"role":22,"phone":13,"phoneExt":13,"email":13},"Marie-Eve Caron",{"name":149,"role":22,"phone":13,"phoneExt":13,"email":13},"Linda-Suzanne Vincent, MD",{"type":151,"investigatorFullName":152,"investigatorTitle":153,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Dr. Tamim Niazi","Principal investigator","100253108",false,"NCT02573636","The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients with Biochemical Failure Status Post Salvage or Radical Radiation Therapy","Inclusion Criteria:\n\n* T3a +\n* PSA \\> 20\n* Gleason 8 or higher\n* Karnofsky performance status ≥ 70.\n* Signed study-specific informed consent\n\nExclusion Criteria:\n\n\\-","MALE","18 Years",{"count":162,"type":163},208,"ESTIMATED","OBSERVATIONAL","The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.",[167],"Prostate Cancer","2024-12-02",{"date":170,"type":171},"2024-12-04","ACTUAL",{"date":173,"type":171},"2016-03",{"date":175,"type":163},"2027-03",{"name":5,"class":6},9]