[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486486":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":43,"collaborators":26,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":26,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":26,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":26},{"fullName":5,"class":6},"University of Leeds","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High dose-rate brachytherapy","ACTIVE_COMPARATOR","Two HDR-BT treatment schedules, either a single fraction 19Gy treatment or 27Gy in 2 fractions approximately 2 weeks apart will be used to be decided by treating centre.",[13],"Radiation: Brachytherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Ultra-hypofractionated external beam radiotherapy","EXPERIMENTAL","Patients will receive 5 fractions of 7.25Gy per fraction which will be delivered alternate days over no more than 2 weeks to provide a total dose of 36.25Gy.",[19],"Radiation: Sterotactic Body Radiotherapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Brachytherapy","High Dose-Rate Brachytherapy",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sterotactic Body Radiotherapy","Hypofractionated External Beam Radiotherapy",[15],[32],{"name":33,"affiliation":5,"role":34},"Ann Henry","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","0113 2067630","a.henry@leeds.ac.uk",{"name":41,"role":37,"phone":38,"phoneExt":26,"email":42},"Jim Zhong","j.zhong@leeds.ac.uk",{"type":34,"investigatorFullName":33,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Associate Professor in Clinical Oncology","100486486","prostate-reirradiation-toxicity-outcomes-feasibility-study-100486486",false,"NCT05614700","Prostate Reirradiation Toxicity Outcomes Feasibility Study","Reirradiation Options for Previously Irradiated Prostate Cancer (RO-PIP): Feasibility Randomised Clinical Trial Investigating Toxicity Outcomes Following Reirradiation With Ultra-hypofractionated External Beam Radiotherapy vs. High Dose Rate Brachytherapy","RO-PIP","Inclusion Criteria:\n\n* Male individuals aged over 18 years\n* Histologically confirmed locally recurrent prostate cancer (following previous radiotherapy no less than 2 years ago)\n* No metastatic disease\n* Able and willing to provide an informed consent to participate\n* World Health Organisation (WHO) performance status 0-2\n* Reasonable urinary function (IPSS \\\u003C 20 and Qmax \\> 10 ml\u002Fsecond on flow tests)\n* Greater than 10 year life expectancy\n\nExclusion Criteria:\n\n* Patients who are unfit for a general anaesthetic due to other comorbidities\n* Clinical or radiological evidence of metastatic prostate disease\n* Any patient with a medical or psychiatric condition that impairs their ability to give informed consent\n* Contraindication or intolerance of magnetic resonance scanning\n* Prior prostatectomy\n* History of inflammatory bowel disease.","MALE","18 Years",{"count":56,"type":57},60,"ESTIMATED","INTERVENTIONAL",[60],"NA","The RO-PIP trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage ultra-hypofractionated external beam radiotherapy or high dose rate brachytherapy and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.",[63,64],"Prostate Cancer","Radiotherapy Side Effect","NOT_YET_RECRUITING","2022-11-14",{"date":68,"type":69},"2022-11-15","ACTUAL",{"date":68,"type":57},{"date":72,"type":57},"2026-11-15",{"name":5,"class":6}]