[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494232":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":53,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"The Greater Poland Cancer Centre","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Experimental: All recruited participants will be treated with salvage partial (focal) prostate brachytherapy for the lesion of recurrent prostate cancer with appropriate margin.",[13],"Radiation: brachytherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","brachytherapy","Radiation: focal low dose rate or high dose rate brachytherapy for the lesion with appropriate margin, defined in magnetic resonance or positron emission tomography All recruited participants will be treated with interstitial brachytherapy for local recurrence of prostate cancer. The low dose rate of brachytherapy is used with a total dose of 145 Gy in the clinical target volume for participants after hypofractionated radiotherapy, a high dose rate brachytherapy as monotherapy or boost with external beam radiotherapy The high dose rate brachytherapy with two fractions of 13 Gy in the clinical target volume with a 3 to 14 days break is used after primary low dose rate brachytherapy or external beam radiotherapy alone.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Wojciech Burchardt, PhD, MD","Greater Poland Cancer Centre \u002F Brachytherapy Department","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+48505149659","wojciech.burchardt@wco.pl",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Ewa Tańska, PhD, MSc.","+618850767","ewa.tanska@wco.pl",[36],{"facility":24,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Poznan","Greater Poland Voivodeship","61-866","Poland","PL",{"type":44,"coordinates":45},"Point",[46,47],16.92993,52.40692,{"lat":47,"lon":46},[50,52],{"name":51,"role":28,"phone":29,"phoneExt":20,"email":30},"Wojciech Burchardt, Phd, MD",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"type":54,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100494232","focal-salvage-brachytherapy-study-focasabra-100494232",false,"NCT05715502","Focal Salvage Brachytherapy Study (FocaSaBra)","Assessment of the Toxicity of Focal Salvage Brachytherapy of Recurrent Prostate Cancer After Prior Radiotherapy - the Prospective Focal Salvage Brachytherapy Study (FocaSaBra)","FocaSaBra","Inclusion Criteria:\n\n* Histopathologically confirmed by biopsy (fusion mapping biopsy preferred) recurrence of prostate cancer after prior radical radiotherapy (brachytherapy, external beam radiotherapy alone or with brachytherapy boost, stereotaxic radiotherapy)\n* Localized tumor lesion assessed by MRI or in the case of MR contraindications with TRUS and CT\n* Exclusion of distant metastases using CT, MR, or PET imaging\n* PSA doubling time over six months\n* PSA value \\\u003C10 ng \u002F ml\n* No anti-androgen treatment in the year prior\n* Dysuria on the IPSS (International Prostate Symptom Score) ≤ 20 points\n* General condition according to the WHO scale ≤ 2\n* Signing informed consent to participate in the study\n\nExclusion Criteria:\n\n* PSA value\\> 10ng \u002F ml\n* General condition according to the WHO scale\\> 2\n* Dysuria on the IPSS scale\\> 20 points\n* PSA doubling time \\\u003C6 months\n* Inability to discontinue anticoagulants.\n* An active urinary tract infection.\n* Contraindications to general anesthesia\n* Active inflammatory bowel diseases.\n* Second active cancer or treatment with completion less than 3 years earlier, except for low-stage skin cancer\n* Estimated Survival \\\u003C5 years","MALE","18 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"NA","The aim of this prospective phase II study is to evaluate the toxicity of salvage partial (focal) prostate brachytherapy in patients after prior radiotherapy (standard teleradiotherapy with \u002F without brachytherapy, hypofractionated, self-reactive HDR \u002F LDR brachytherapy) with local recurrence on the part of the prostate gland.",[73],"Prostate Cancer",[75,76,17,77,78,79],"recurrence","prostate cancer","focal treatment","salvage treatment","radiotherapy","2025-04-28",{"date":82,"type":83},"2025-04-30","ACTUAL",{"date":85,"type":83},"2022-05-01",{"date":87,"type":67},"2028-12-31",{"name":5,"class":6},1]