[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555910":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":58,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"UMC Utrecht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ultrahypofractionated MRgRT in 2 fractions","EXPERIMENTAL","MRgRT to the prostate in 2 fractions of 12 Gy, with a focal boost of 13.5 Gy to the gross tumor volume (GTV), administered over the course of 8 days.",[13],"Radiation: Ultrahypofractionated MRgRT in 2 fractions",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care: MRgRT in 5 fractions","ACTIVE_COMPARATOR","MRgRT to the prostate in 5 fractions of 7.25 Gy to the prostate without focal boost, administered over the course of 16-18 days.",[19],"Radiation: Standard of care: MRgRT in 5 fractions",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","2x12 Gy with boost to GTV up to 13.5 Gy",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"5x7.25 Gy",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Tariq A. Lalmahomed, MD","CONTACT","+31 (0)887574536","t.a.lalmahomed-2@umcutrecht.nl",[36],{"facility":37,"status":38,"city":39,"state":25,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University Medical Center Utrecht","RECRUITING","Utrecht","3584 CX","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],5.12222,52.09083,{"lat":47,"lon":46},[50,52,55],{"name":51,"role":32,"phone":33,"phoneExt":25,"email":34},"Tariq A Lalmahomed, MD",{"name":53,"role":32,"phone":25,"phoneExt":25,"email":54},"Jochem R.N. Van der Voort van Zyp, MD PhD","j.r.n.vandervoortvanzyp@umcutrecht.nl",{"name":56,"role":57,"phone":25,"phoneExt":25,"email":25},"Jochem RN Van der Voort van Zyp, MD PhD","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"J.R.N. van der Voort van Zyp","Principal Investigator","100555910","two-fraction-ultrahypofractionated-radiotherapy-with-focal-boost-for-intermediate-risk-localized-prostate-cancer-100555910",false,"NCT06518226","Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer","Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial","TURBO","Inclusion Criteria:\n\n* Age ≥18 years\n* Histopathological confirmation of prostate adenocarcinoma requiring radical treatment\n* European Association of Urology (EAU) intermediate risk prostate cancer, defined as Prostate Specific Antigen (PSA) level of \\\u003C 20 ng\u002Fml, Gleason score ≤ 7, cT1c-cT2b\u002FiT3a (non-bulky, \\\u003C 20mm)\n* Written informed consent\n* Ability and willingness to comply with Patient Reported Outcome Measure (PROM) questionnaires schedule throughout the study\n* Inclusion in the Multi-OutcoMe EvaluatioN of radiation Therapy Using the MR-Linac Study (MOMENTUM)\n\nExclusion Criteria:\n\n* Contraindications to MRI\n* International Prostate Symptom Score (IPSS) of 15 or higher\n* Prostate volume \\> 80 cc\n* Comorbidities which predispose to significant toxicity (e.g., inflammatory bowel disease)\n* Metal pelvic implants which cause artefact on MR-imaging sequences\n* Previous radical prostatectomy\n* Previous pelvic radiotherapy\n* Previous invasive malignancy within the last 5 years, excluding basal cell carcinoma of the skin","MALE","18 Years",{"count":72,"type":73},160,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are:\n\n\\- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects?\n\nParticipants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.",[79,80,81],"Prostate Cancer","Prostate Adenocarcinoma","Localized Prostate Carcinoma",[83,84,85,86,87],"MR-guided adaptive radiotherapy","MRgRT","Quality of life","Patient-reported outcomes","Ultrahypofractionation","2024-07-18",{"date":90,"type":91},"2024-07-24","ACTUAL",{"date":93,"type":91},"2024-03-28",{"date":95,"type":73},"2031-02-01",{"name":5,"class":6},1]