[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437962":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":45,"centralContacts":50,"locations":57,"responsibleParty":144,"collaborators":148,"id":168,"slug":169,"hasResults":170,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":170,"sex":175,"minAge":176,"maxAge":55,"enrollmentInfo":177,"targetDuration":55,"studyType":180,"phases":181,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":60,"whyStopped":55,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"Umeå University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","ADT+ARPI to all patients and local RT +\u002F- pelvic fields to de novo patients",[13,14],"Combination Product: androgen deprivation therapy","Radiation: Radiotherapy",{"label":16,"type":17,"description":18,"interventionNames":19},"SBRT+Standard of Care","EXPERIMENTAL","SBRT to all PSMA+ lesions in addition to SoC and salvage RT to the prostate bed +\u002F- pelvic fields if recurrent post prostatectomy and PSMA-PET+ in the pelvis",[20,13,14],"Radiation: stereotactic body radiotherapy",[22,30,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","stereotactic body radiotherapy","30 Gy in 3 fractions alternatively 40 Gy in 5 fractions delivered with stereotactic radiotherapy-principles",[16],[28,29],"stereotactic ablative radiotherapy","image guided radiotherapy",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"COMBINATION_PRODUCT","androgen deprivation therapy","Medical castration and next-generation Hormonal Agent along with radiotherapy to the prostate in de novo oligometastatic prostate cancer",[16,9],[36,37,38],"gonadotropin releasing hormone-agonist","gonadotropin releasing hormone-antagonist","androgen-receptor pathway inhibitor (ARPI)",{"type":23,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Radiotherapy","RT to the prostate for de novo patients",[16,9],[44],"external radiotherapy",[46],{"name":47,"affiliation":48,"role":49},"Karin Söderkvist","Region Västerbotten, Umeå University","PRINCIPAL_INVESTIGATOR",[51],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Karin Söderkvist, MD,PhD","CONTACT","+46 90 7853222",null,"karin.soderkvist@umu.se",[58,74,87,96,106,119,131],{"facility":59,"status":60,"city":61,"state":61,"zip":55,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Region Skåne","RECRUITING","Lund","Sweden","SE",{"type":65,"coordinates":66},"Point",[67,68],13.19321,55.70584,{"lat":68,"lon":67},[71],{"name":72,"role":53,"phone":55,"phoneExt":55,"email":73},"Adalsteinn Gunnlaugsson, Senior Consultant","adalsteinn.gunnlaugsson@skane.se",{"facility":75,"status":60,"city":76,"state":77,"zip":55,"country":62,"countryCode":63,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Capio St Göran Hospital","Stockholm","Region Stockholm",{"type":65,"coordinates":79},[80,81],18.06871,59.32938,{"lat":81,"lon":80},[84],{"name":85,"role":53,"phone":55,"phoneExt":55,"email":86},"Martina Westin, Senior Consultant","martina.westin@capiostgoran.se",{"facility":88,"status":60,"city":76,"state":77,"zip":55,"country":62,"countryCode":63,"cosmosGeoPoint":89,"geoPoint":91,"contacts":92},"Södersjukhuset",{"type":65,"coordinates":90},[80,81],{"lat":81,"lon":80},[93],{"name":94,"role":53,"phone":55,"phoneExt":55,"email":95},"Chunde Li, Senior Consultant","chunde.li@regionstockholm.se",{"facility":97,"status":60,"city":76,"state":98,"zip":55,"country":62,"countryCode":63,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Karolinska University Hospital","Stockholm County",{"type":65,"coordinates":100},[80,81],{"lat":81,"lon":80},[103],{"name":104,"role":53,"phone":55,"phoneExt":55,"email":105},"Mattias Hedman, MD","mattias.hedman@regionstockholm.se",{"facility":107,"status":60,"city":108,"state":109,"zip":110,"country":62,"countryCode":63,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Umeå University hospital","Umeå","Umea","90331",{"type":65,"coordinates":112},[113,114],20.25972,63.82842,{"lat":114,"lon":113},[117],{"name":47,"role":53,"phone":118,"phoneExt":55,"email":56},"0705282558",{"facility":120,"status":60,"city":121,"state":55,"zip":55,"country":62,"countryCode":63,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Ryhovs county hospital","Jönköping",{"type":65,"coordinates":123},[124,125],14.15618,57.78145,{"lat":125,"lon":124},[128],{"name":129,"role":53,"phone":55,"phoneExt":55,"email":130},"Kirsten Bjornlinger, M.D","Kirsten.bjornlinger@rjl.se",{"facility":132,"status":60,"city":133,"state":134,"zip":55,"country":62,"countryCode":63,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Region Örebro Län","Örebro","Örebro County",{"type":65,"coordinates":136},[137,138],15.2066,59.27412,{"lat":138,"lon":137},[141],{"name":142,"role":53,"phone":55,"phoneExt":55,"email":143},"Jenny Kahlmeter-Brandell, Senior Consultant","jenny.kahlmeter-brandell@regionorebrolan.se",{"type":145,"investigatorFullName":146,"investigatorTitle":147,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"SPONSOR_INVESTIGATOR","Karin Soderkvist","Senior Consultant, PhD",[149,151,152,154,156,158,160,162,164,166],{"name":150,"class":6},"University Hospital, Umeå",{"name":97,"class":6},{"name":153,"class":6},"Stockholm South General Hospital",{"name":155,"class":6},"Region Skane",{"name":157,"class":6},"Ryhov County Hospital",{"name":159,"class":6},"Sahlgrenska University Hospital",{"name":161,"class":6},"Trondheim University Hospital",{"name":163,"class":6},"Capio Sankt Görans Hospital",{"name":165,"class":6},"Alesund Hospital",{"name":167,"class":6},"Region Örebro County","100437962","metastasis-directed-stereotactic-body-radiotherapy-for-oligo-metastatic-hormone-sensitive-prostate-cancer-100437962",false,"NCT04983095","Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer","METRO","Inclusion Criteria:\n\n1. Histologically confirmed prostate cancer (ICD-O-3 C61)\n2. WHO\u002FECOG performance status 0-1\n3. 1-3 skeletal or extra pelvic lymph node metastases detected by PSMA-PET\u002FCT in de novo prostate cancer or PSA-relapse after definitive RT or prostatectomy\n4. Willing and able to provide informed consent-\n\nExclusion Criteria:\n\n1. Castration resistant prostate cancer (progression with castrate levels of testosterone)\n2. Any treatment known to affect PSA (including ADT) for prostate cancer within 6 months (exception: ADT started due to oligometastatic disease within 2 weeks of study entry)\n3. Patient eligible for other treatment (e.g., early docetaxel) than standard treatment described in the protocol as judged by treating physician\n4. Life expectancy \\\u003C3 years by any reason, including concomitant or previous malignancies\n5. Previous radiotherapy or surgery that may interfere with the planned treatment (including intra-prostatic recurrence if previous RT to the prostate)\n6. \\> 3 PSMA-PET\u002FCT positive target lesions (excluding the prostate and regional lymph node metastasis in de novo patients or prostate bed and or regional lymph node metastasis in recurrent patients)\n7. PSMA-PET verified metastases other than skeletal or lymph nodes\n8. Metastases in base of scull and\u002For calotte\n9. Any target lesions not treatable with image guided RT (IGRT) due to overlap with previous RT fields or exceeded dose constraint to OAR(s) as specified in study protocol","MALE","18 Years",{"count":178,"type":179},118,"ESTIMATED","INTERVENTIONAL",[182],"NA","The study is an open label, multi-centre, randomized phase III study. The patients will be randomised in a 1:1 ratio to treatment consisting of\n\n* Arm A: MD-SBRT in addition to standard treatment\n* Arm B: Standard treatment\n\nStudy population: Patients with hormone sensitive prostate cancer (HSPC) with oligometastatic disease detected by PSMA-PET\u002FDT. This includes patients with de novo oligometastatic HSPC and recurrent HSPC after primary RT or prostatectomy.\n\nPrimary endpoint: Failure free survival\n\nSecondary endpoints:\n\n* Predictive value of investigated biomarkers in blood and imaging\n* Acute and late toxicity after MD-SBRT\n* PROM at 3 months, 1, 3 and 5 years\n* Castration resistant prostate cancer, CRPC\n* Overall survival\n* Differences in outcome between patients by strata\n\nStratification: To avoid imbalance between treatment arms the minimisation method will be used to achieve balance between de novo oligo-metastatic and oligo-recurrent patients, as well as treatment site.\n\nSafety evaluation: Adverse events and side effects graded according to CTCAE v5.0 will be collected every 6th month. Serious Adverse Events are to be reported within 24 hours throughout the study duration.\n\nStatistical methods: Survival endpoints will be calculated using the Kaplan-Meier method with differences compared using the stratified log-rank test. Randomization time is set as baseline time. Pre-planned subgroup analysis will occur based on pre-specified stratification variables. A Cox multivariable regression model will be used to determine factors predictive of survival. Safety analysis will be performed with Mann-Whitney U-test or Fishers exact test.\n\nCriteria for evaluation: Per protocol (patients that have started study treatment) and Intention to treat (all included patients).\n\nPlanned sample size: 118 patients\n\nAnalysis plan:\n\nThe primary end point will be analysed after pre-specified number of events have occurred. All patients randomised to SBRT will be followed minimum 60 months for toxicity. Safety analysis of acute toxicity will take place after median follow up of 6 months. Safety analysis of late toxicity will be analysed after study closure.\n\nDuration of the study:\n\nThree to five years inclusion. 72 months of follow-up after randomization of the last patient.",[185,186,187],"Prostate Cancer Metastatic","Radiation Therapy","Positron-Emission Tomography",[189,190,191],"Oligometastatic Prostate Cancer","Hormone Sensitive","Stereotactic Body Radiotherapy","2026-02-11",{"date":194,"type":195},"2026-02-17","ACTUAL",{"date":197,"type":195},"2021-10-27",{"date":199,"type":179},"2033-12",{"name":146,"class":6},7]