[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659227":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":44,"armGroups":39,"interventions":39,"overallOfficials":45,"centralContacts":53,"locations":61,"responsibleParty":223,"collaborators":39,"id":225,"slug":226,"hasResults":227,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":227,"sex":233,"minAge":234,"maxAge":39,"enrollmentInfo":235,"targetDuration":238,"studyType":239,"phases":39,"briefSummary":240,"conditions":241,"keywords":247,"overallStatus":64,"whyStopped":39,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},{"fullName":5,"class":6},"Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Biochemical relapse-free survival","Time from salvage brachytherapy to biochemical recurrence of prostate cancer, defined according to the Phoenix definition as a rise in prostate-specific antigen (PSA) of ≥2 ng\u002FmL above the post-treatment PSA nadir. Patients without biochemical recurrence will be censored at the date of their last available PSA assessment or at the end of the study follow-up. PSA measurements will be obtained at 1 month after treatment and subsequently every 6 months through 48 months.","From the date of salvage brachytherapy to 48 months after treatment",[14,18,22,25,29,33,36],{"measure":15,"description":16,"timeFrame":17},"Baseline Characteristics","Initial disease characteristics: Initial PSA, Gleason\u002FGrade Group, Stage Biopsy characteristics, Initial imaging, Initial treatment.\n\nDisease characteristics at recurrence: PSA at recurrence, prostate-specific antigen doubling time (PSADT), Location of recurrence, Recurrence biopsy, Urinary symptoms, Imaging findings","Baseline, Day 0",{"measure":19,"description":20,"timeFrame":21},"Incidence of Late and Chronic Treatment-Related Toxicity","Incidence and severity of late and chronic treatment-related toxicity following salvage brachytherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Toxicities will include genitourinary and gastrointestinal toxicities and other treatment-related adverse events identified during follow-up.","From 1 month after salvage brachytherapy to 48 months after treatment",{"measure":23,"description":24,"timeFrame":12},"Local Relapse-Free Survival","Time from salvage brachytherapy to radiologically confirmed local recurrence of prostate cancer. Local recurrence will be assessed using imaging techniques, including prostate MRI, choline PET, and\u002For PSMA PET, according to routine clinical practice. Patients without radiologically confirmed local recurrence will be censored at the date of their last available imaging assessment or at the end of the study follow-up.",{"measure":26,"description":27,"timeFrame":28},"Incidence of Acute Treatment-Related Toxicity","Incidence and severity of acute treatment-related toxicity following salvage brachytherapy, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Acute toxicity will include genitourinary and gastrointestinal toxicities and other treatment-related adverse events occurring during the acute post-treatment period.","From the date of salvage brachytherapy to 1 month after treatment",{"measure":30,"description":31,"timeFrame":32},"Change in International Prostate Symptom Score (IPSS) From Baseline","Change in urinary symptoms assessed using the International Prostate Symptom Score (IPSS). The IPSS will be assessed before salvage brachytherapy and during follow-up every 6 months. The change from baseline will be evaluated over the study follow-up period.","Baseline and every 6 months after salvage brachytherapy through 48 months",{"measure":34,"description":35,"timeFrame":32},"Change in Prostate Cancer-Specific Quality of Life (FACT-P) From Baseline","Change in health-related quality of life assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. The FACT-P is a 39-item questionnaire assessing health-related quality of life in patients with prostate cancer. The total score ranges from 0 to 156, with higher scores indicating better health-related quality of life. The questionnaire will be administered before salvage brachytherapy and during follow-up every 6 months. Changes from baseline in the FACT-P total score will be evaluated throughout the study follow-up period.",{"measure":37,"description":38,"timeFrame":32},"Change in Prostate Cancer-Specific Quality of Life (EORTC QLQ-PR25) From Baseline","Change in prostate cancer-specific health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module (EORTC QLQ-PR25). The EORTC QLQ-PR25 consists of 25 items scored on a 0 to 100 scale after linear transformation. Higher scores indicate greater symptom burden for symptom scales and higher levels of functioning or activity for the sexual activity\u002Ffunction scales. The questionnaire will be administered before salvage brachytherapy and during follow-up every 6 months. Changes from baseline in the EORTC QLQ-PR25 scores will be evaluated throughout the study follow-up period..",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","The objectives of this prospective, multicenter study are:\n\n* Primary:\n\n  1\\. Biochemical relapse-free survival, defined as the time to biochemical relapse (nadir plus 2 ng\u002FmL - Phoenix criteria).\n* Secondary:\n\n  1. Local relapse-free survival, defined as the time from treatment to local relapse confirmed by imaging (choline PET\u002FMRI).\n  2. Analysis of acute and chronic toxicity (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 5).\n  3. Assessment of patient quality of life before and after treatment to analyze the impact of local re-irradiation on daily life using the following questionnaires: International Prostate Symptom Score (IPSS), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Prostate Module (EORTC QLQ-PR25).\n\nPrimary outcome measure: Biochemical relapse-free survival, and analysis of toxicity and quality of life in patients treated with salvage brachytherapy following radical treatment.\n\nStudy population, total number of subjects, and duration: Patients who received radical-intent radiotherapy as their initial treatment (brachytherapy alone, external beam radiotherapy, or external beam radiotherapy plus a brachytherapy boost) and were diagnosed with local recurrence via next-generation imaging techniques (choline PET\u002FPSMA PET) and prior biopsy; these patients are scheduled to undergo salvage brachytherapy as part of routine clinical practice. A calculated sample size of 63 patients will be reached over a 2-year recruitment period. Follow-up will be conducted according to standard clinical practice every 6 months for the 4-year duration of the study.","Patients treated with radical-intent radiotherapy as their primary treatment (brachytherapy alone, external beam radiotherapy, or external beam radiotherapy plus a brachytherapy boost) who have been diagnosed with local recurrence via next-generation imaging techniques (Choline PET or PSMA PET) and prior biopsy, and who are to undergo salvage brachytherapy as part of routine clinical practice.",[46,50],{"name":47,"affiliation":48,"role":49},"Patricia Willisch Santamaría, MD PhD","Galicia Sur Health Research Institute","STUDY_DIRECTOR",{"name":51,"affiliation":5,"role":52},"Pablo Raña Díez","STUDY_CHAIR",[54,58],{"name":47,"role":55,"phone":56,"phoneExt":39,"email":57},"CONTACT","986 811 714","patricia.willisch.santamaria@sergas.es",{"name":51,"role":55,"phone":59,"phoneExt":39,"email":60},"914009600","investigacion@seor.es",[62,83,99,115,130,147,162,178,192,207],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Hospital HCB Benidorm","RECRUITING","Benidorm","Alicante","03501","Spain","ES",{"type":71,"coordinates":72},"Point",[73,74],-0.13098,38.53816,{"lat":74,"lon":73},[77,81],{"name":78,"role":55,"phone":79,"phoneExt":39,"email":80},"Silvia Rodríguez Villalba, MD","965 85 38 50","srodriguez@clinicabenidorm.com",{"name":78,"role":82,"phone":39,"phoneExt":39,"email":39},"PRINCIPAL_INVESTIGATOR",{"facility":84,"status":64,"city":85,"state":86,"zip":87,"country":68,"countryCode":69,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Instituto Catalán de Oncología L'Hospitalet","L'Hospitalet de Llobregat","Barcelona","08908",{"type":71,"coordinates":89},[90,91],2.10028,41.35967,{"lat":91,"lon":90},[94,98],{"name":95,"role":55,"phone":96,"phoneExt":39,"email":97},"Andrea Slocker Escarpa, MD","932607733","andrea.slocker@iconcologia.net",{"name":95,"role":82,"phone":39,"phoneExt":39,"email":39},{"facility":100,"status":64,"city":101,"state":102,"zip":103,"country":68,"countryCode":69,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Hospital Universitario Marqués de Valdecilla","Santander","Cantabria","39008",{"type":71,"coordinates":105},[106,107],-3.80493,43.46589,{"lat":107,"lon":106},[110,114],{"name":111,"role":55,"phone":112,"phoneExt":39,"email":113},"Ana Soledad García Blanco, MD","942 20 25 20","anasoledad.garcia@scsalud.es",{"name":111,"role":82,"phone":39,"phoneExt":39,"email":39},{"facility":116,"status":64,"city":117,"state":117,"zip":118,"country":68,"countryCode":69,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Hospital Universitario Reina Sofía","Córdoba","14004",{"type":71,"coordinates":120},[121,122],-4.77275,37.89155,{"lat":122,"lon":121},[125,129],{"name":126,"role":55,"phone":127,"phoneExt":39,"email":128},"Sonia García Cabezas, MD","957 010 000","sonia.garcia.cabezas.sspa@juntadeandalucia.es",{"name":126,"role":82,"phone":39,"phoneExt":39,"email":39},{"facility":131,"status":132,"city":133,"state":134,"zip":135,"country":68,"countryCode":69,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Instituto Oncológico de San Sebastián (Onkologikoa)","NOT_YET_RECRUITING","San Sebastián","Guipuzcoa","20014",{"type":71,"coordinates":137},[138,139],-5.9,43.56667,{"lat":139,"lon":138},[142,146],{"name":143,"role":55,"phone":144,"phoneExt":39,"email":145},"Alai Goñi Ramírez, MD","943 32 80 00","agoni@onkologikoa.org",{"name":143,"role":82,"phone":39,"phoneExt":39,"email":39},{"facility":148,"status":64,"city":149,"state":149,"zip":150,"country":68,"countryCode":69,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Hospital Universitario Ramón y Cajal","Madrid","28034",{"type":71,"coordinates":152},[153,154],-3.70256,40.4165,{"lat":154,"lon":153},[157,161],{"name":158,"role":55,"phone":159,"phoneExt":39,"email":160},"María Teresa Muñoz Migueláñez, MD","91 336 84 34","mmmiguelanez@salud.madrid.org",{"name":158,"role":82,"phone":39,"phoneExt":39,"email":39},{"facility":163,"status":64,"city":164,"state":165,"zip":166,"country":68,"countryCode":69,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Hospital Universitario de Navarra","Pamplona","Navarre","31008",{"type":71,"coordinates":168},[169,170],-1.64323,42.81687,{"lat":170,"lon":169},[173,177],{"name":174,"role":55,"phone":175,"phoneExt":39,"email":176},"Ignacio Visus Fernández de Manzano, MD","848 42 21 60","ignacio.visus.fdezdemanzano@navarra.es",{"name":174,"role":82,"phone":39,"phoneExt":39,"email":39},{"facility":179,"status":64,"city":180,"state":181,"zip":182,"country":68,"countryCode":69,"cosmosGeoPoint":183,"geoPoint":187,"contacts":188},"Hospital Meixoeiro","Vigo","Pontevedra","36312",{"type":71,"coordinates":184},[185,186],-8.72264,42.23282,{"lat":186,"lon":185},[189,190],{"name":47,"role":55,"phone":56,"phoneExt":39,"email":57},{"name":191,"role":82,"phone":39,"phoneExt":39,"email":39},"Patricia Willisch Santamaría, MD",{"facility":193,"status":64,"city":194,"state":194,"zip":195,"country":68,"countryCode":69,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"Hospital Universitario y Politécnico La Fe","Valencia","46026",{"type":71,"coordinates":197},[198,199],-0.37966,39.47391,{"lat":199,"lon":198},[202,206],{"name":203,"role":55,"phone":204,"phoneExt":39,"email":205},"Francisco Javier Celada Álvarez, MD","961 24 40 00","celada_fra@gva.es",{"name":203,"role":82,"phone":39,"phoneExt":39,"email":39},{"facility":208,"status":132,"city":209,"state":210,"zip":211,"country":68,"countryCode":69,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Hospital Universitario de Cruces","Barakaldo","Vizcaya","48903",{"type":71,"coordinates":213},[214,215],-2.98813,43.29639,{"lat":215,"lon":214},[218,222],{"name":219,"role":55,"phone":220,"phoneExt":39,"email":221},"David Büchser García, MD","946 006 591","david.buechsergarcia@osakidetza.eus",{"name":219,"role":82,"phone":39,"phoneExt":39,"email":39},{"type":224,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100659227","multicenter-prospective-observational-study-on-prostate-salvage-using-high-dose-rate-brachytherapy-100659227",false,"NCT07860528","Study on Prostate Salvage Using High-dose-rate Brachytherapy","Multicenter Prospective Observational Study on Prostate Salvage Using High-dose-rate Brachytherapy","PROSCATE","Inclusion Criteria:\n\n* Age over 18 years.\n* Patients diagnosed with local recurrence confirmed by next-generation imaging and a positive biopsy.\n* Hormone-sensitive patient.\n* Patients whose initial treatment consisted of brachytherapy alone, external beam radiotherapy, or external beam radiotherapy with a prostate brachytherapy boost.\n\nExclusion Criteria:\n\n* Metastatic disease.\n* Castration-resistant prostate cancer, defined according to EAU (European Association of Urology) guidelines: A patient who progresses despite maintaining testosterone levels within the castration range (testosterone \\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL) and presents with at least one of the following factors: Three consecutive rises in PSA (Prostate-Specific Antigen) levels, measured one week apart, representing two increases of 50% above the nadir, with a PSA level \\>2; PSA progression despite successive hormonal manipulations; Progression of bone lesions: progression or appearance of two or more bone lesions, or soft-tissue progression according to Response Evaluation Criteria in Solid Tumors (RECIST criteria).","ALL","18 Years",{"count":236,"type":237},63,"ESTIMATED","4 Years","OBSERVATIONAL","A prospective, observational, multicenter study analyzing salvage treatment for prostate cancer-diagnosed via next-generation imaging (choline positron emission tomography (PET)\u002Fprostate-specific membrane antigen (PSMA) PET and magnetic resonance imaging (MRI)) and positive biopsy-using two fractions of high-dose-rate (HDR) brachytherapy.",[242,243,244,245,246],"Prostate Cancer","Locally Recurrent Cancer","Biochemically Recurrent Prostate Carcinoma","Toxicity Radiation","Quality of Life",[248,249,250,251,10,252,253,254,255,256,257,258,259,260,261],"Prostate cancer","Salvage brachytherapy","Local recurrence","Reirradiation","Local recurrence-free survival","Biochemical recurrence","Acute and chronic toxicity","Quality of life","Choline PET; PSMA PET","MRI","Prostate biopsy","External beam radiotherapy","Brachytherapy boost","Salvage treatment","2026-10-06",{"date":264,"type":265},"2026-10-09","ACTUAL",{"date":267,"type":265},"2026-03-11",{"date":269,"type":237},"2032-04-30",{"name":5,"class":6},10]