[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411782":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":47,"responsibleParty":204,"collaborators":206,"id":209,"slug":210,"hasResults":211,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":211,"sex":217,"minAge":218,"maxAge":219,"enrollmentInfo":220,"targetDuration":41,"studyType":223,"phases":224,"briefSummary":226,"conditions":227,"keywords":230,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional","ACTIVE_COMPARATOR","Conventional sEBRT",[13],"Radiation: Conventional sEBRT",{"label":15,"type":16,"description":17,"interventionNames":18},"Hypofractionation","EXPERIMENTAL","Hypofractionated sEBRT",[19],"Radiation: Hypofractionated sEBRT",[21,27],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks",[9],[26],"Conventional salvage external beam radiation therapy",{"type":22,"name":17,"description":28,"armGroupLabels":29,"otherNames":30},"A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks",[15],[31],"Hypofractionated salvage external beam radiation therapy",[33],{"name":34,"affiliation":5,"role":35},"S. Aluwini, Dr.","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"F. Staal, MD","CONTACT","0031655257985",null,"f.h.e.staal@umcg.nl",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"P. Veldhuijzen van Zanten","0031503614659","peryton@rt.umcg.nl",[48,64,75,87,99,110,123,133,145,157,168,179,191],{"facility":49,"status":50,"city":51,"state":52,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Radiotherapiegroep","RECRUITING","Arnhem","Gelderland","Netherlands","NL",{"type":56,"coordinates":57},"Point",[58,59],5.91111,51.98,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":41,"phoneExt":41,"email":41},"D. Haverkort, MD",{"facility":65,"status":50,"city":66,"state":52,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Radboud University Medical Center","Nijmegen",{"type":56,"coordinates":68},[69,70],5.85278,51.8425,{"lat":70,"lon":69},[73],{"name":74,"role":39,"phone":41,"phoneExt":41,"email":41},"R.J. Smeenk, MD, PhD",{"facility":76,"status":50,"city":77,"state":78,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Maastro Clinic","Maastricht","Limburg",{"type":56,"coordinates":80},[81,82],5.68889,50.84833,{"lat":82,"lon":81},[85],{"name":86,"role":39,"phone":41,"phoneExt":41,"email":41},"B. Vanneste, MD",{"facility":88,"status":50,"city":89,"state":90,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Catharina-Hospital","Eindhoven","North Brabant",{"type":56,"coordinates":92},[93,94],5.47778,51.44083,{"lat":94,"lon":93},[97],{"name":98,"role":39,"phone":41,"phoneExt":41,"email":41},"T.C.G. Budiharto, MD, PhD",{"facility":100,"status":50,"city":101,"state":90,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Verbeeten Institute","Tilburg",{"type":56,"coordinates":103},[104,105],5.0913,51.55551,{"lat":105,"lon":104},[108],{"name":109,"role":39,"phone":41,"phoneExt":41,"email":41},"M.A.E. van de Sande, MD",{"facility":111,"status":112,"city":113,"state":114,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Amsterdam UMC (Location VUmc)","NOT_YET_RECRUITING","Amsterdam","North Holland",{"type":56,"coordinates":116},[117,118],4.88969,52.37403,{"lat":118,"lon":117},[121],{"name":122,"role":39,"phone":41,"phoneExt":41,"email":41},"J. van Moorselaar, Professor",{"facility":49,"status":50,"city":124,"state":125,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Deventer","Overijssel",{"type":56,"coordinates":127},[128,129],6.16389,52.255,{"lat":129,"lon":128},[132],{"name":63,"role":39,"phone":41,"phoneExt":41,"email":41},{"facility":134,"status":50,"city":135,"state":136,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Radiotherapy Institute Friesland","Leeuwarden","Provincie Friesland",{"type":56,"coordinates":138},[139,140],5.80973,53.20271,{"lat":140,"lon":139},[143],{"name":144,"role":39,"phone":41,"phoneExt":41,"email":41},"M. De Jong, MD",{"facility":146,"status":112,"city":147,"state":148,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Leiden University Medical Center","Leiden","South Holland",{"type":56,"coordinates":150},[151,152],4.49306,52.15833,{"lat":152,"lon":151},[155],{"name":156,"role":39,"phone":41,"phoneExt":41,"email":41},"S. Rademakers, MD, PhD",{"facility":158,"status":112,"city":159,"state":148,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Erasmus Medical Center","Rotterdam",{"type":56,"coordinates":161},[162,163],4.47917,51.9225,{"lat":163,"lon":162},[166],{"name":167,"role":39,"phone":41,"phoneExt":41,"email":41},"L. Incocci, Professor",{"facility":169,"status":112,"city":170,"state":148,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Haga Hospital","The Hague",{"type":56,"coordinates":172},[173,174],4.29861,52.07667,{"lat":174,"lon":173},[177],{"name":178,"role":39,"phone":41,"phoneExt":41,"email":41},"B. Hollman, MD",{"facility":180,"status":50,"city":181,"state":41,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Zuidwest Radiotherapeutisch Instituut (ZRTI)","Flushing",{"type":56,"coordinates":183},[184,185],3.57361,51.4425,{"lat":185,"lon":184},[188],{"name":189,"role":39,"phone":41,"phoneExt":41,"email":190},"Inge Jacobs","i.jacobs@zrti.nl",{"facility":192,"status":50,"city":193,"state":41,"zip":194,"country":53,"countryCode":54,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"UMCG","Groningen","9713GZ",{"type":56,"coordinates":196},[197,198],6.56667,53.21917,{"lat":198,"lon":197},[201],{"name":202,"role":39,"phone":41,"phoneExt":41,"email":203},"F.H.E. Staal, MD.","PERYTON@rt.umcg.nl",{"type":205,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[207],{"name":208,"class":6},"Dutch Cancer Society","100411782","phase-3-psma-pet-guided-hypofractionated-salvage-prostate-bed-radiotherapy-100411782",false,"NCT04642027","PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy","PSMA-PET Guided Hypofractionated Salvage Prostate Bed Radiotherapy of Biochemical Failure After Radical Prostatectomy for Prostate Cancer","PERYTON","Inclusion Criteria:\n\n* Patients with prostate adenocarcinoma treated with radical prostatectomy;\n* Tumour stage pT2-4, R0-1, pN0, or cN0, cNx according to the UICC TNM 2009, only with Gleason score available;\n* No lymph node or distant metastases. A recent PSMA-PET scan (\\\u003C 60 days) without evidence of lymph node or distant metastases;\n* PSA progression after prostatectomy defined as two consecutive rises with the final PSA \\> 0.1 ng\u002FmL or 3 consecutive rises. The first value must be measured at least 6 weeks after radical prostatectomy;\n* PSA at inclusion \\\u003C 1.0 ng\u002FmL;\n* WHO performance status 0-2 at inclusion;\n* Age at inclusion between 18 and 80 years;\n* Written (signed and dated) informed consent prior to registration.\n\nExclusion Criteria:\n\n* Prior pelvic irradiation, (chemo)hormonal therapy or orchiectomy;\n* Previous or concurrent active invasive cancers other than superficial non-melanoma skin cancers;\n* Patients with positive nodes or with distant metastases based on the surgical specimen of lymphadenectomy or the following minimum diagnostic workup: PSMA-PET\u002FCT scan, 60 days prior to registration;\n* Double-sided metallic hip prosthesis;\n* Inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out QoL questionnaires.","MALE","18 Years","80 Years",{"count":221,"type":222},538,"ESTIMATED","INTERVENTIONAL",[225],"PHASE3","After radical prostatectomy approximately 15-40% of men develop a biochemical recurrence (BR) within 5 years.\n\nThe standard treatment of post-prostatectomy BR is salvage external beam radiation therapy (sEBRT). sEBRT can provide long-term disease control; with 5 year biochemical progression-free survival (bPFS) up to 60% and with most treatment failures in the first 2 years after sEBRT.\n\nThe main goal of this project is to investigate whether the oncologic outcome in patients with post-prostatectomy recurrent PCa can be improved, by increasing the biological effective radiation dose using a hypofractionated schedule of 20 x 3 = 60 Gy.\n\nThe study is designed as a prospective open phase III randomized multicenter trial. All patients with biochemical recurrence with a PSA \\\u003C 1.0 ng\u002Fml after radical prostatectomy for prostate cancer without evidence of lymph nodes or distance metastases will be included. PSA progression after prostatectomy defined as two consecutive rises with the final PSA \\> 0.1 ng\u002FmL or three consecutive rises will be included.\n\nAll eligible patients will be randomized to one of the following two treatment arms:\n\nArm 1 = Conventional sEBRT to apply a total dose of 70 Gy in 35 daily fractions of 2 Gy during 7 weeks.\n\nArm 2 = Hypofractionated sEBRT to apply a total dose of 60 Gy in 20 fractions of 3 Gy during 4 weeks.\n\nThe primary endpoint will be the 5-year progression-free survival (PFS) after treatment.",[228,229],"Prostate Cancer","Cancer Recurrence",[231,232,15,233,234],"PSMA-PET\u002FCT","Salvage","Radiotherapy","Prostatectomy","2024-02-26",{"date":237,"type":238},"2024-02-28","ACTUAL",{"date":240,"type":238},"2020-09-01",{"date":242,"type":222},"2030-09-01",{"name":5,"class":6},13]