[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100457129":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":25,"responsibleParty":39,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":25,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":25},{"fullName":5,"class":6},"General University Hospital, Prague","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A- early salvage radiotherapy (eSRT)","EXPERIMENTAL","Early salvage radiotherapy (eSRT) will be administered immediately after the confirmation of the biochemical relapse (prostate-specific antigen PSA level increase to ≈ 0,2 ng\u002Fml) after radical prostatectomy with defined risk factors and no clinical recurrence signs on prostate specific membrane antigen positron emission tomography and computed tomography (PSMA PET\u002FCT).",[13],"Radiation: Early salvage radiotherapy (eSRT)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B- delayed salvage radiotherapy (dSRT)","The patient is by the biochemical relapse analysis (PSA level 0,2 ng\u002Fml) referred for further follow-up of PSA values. dSRT is initiated, if PSA further increase to values of ≥ 0.4 ng\u002Fml is confirmed and the presence of a potential clinical relapse is excluded with repeated PSMA-PET-CT in line with standard procedures",[18],"Radiation: Delayed Salvage radiotherapy (dSRT)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Early salvage radiotherapy (eSRT)","eSRT administered immediately after the confirmation of the biochemical relapse (PSA ≈ 0.2ng\u002Fml).\n\n66-70Gy will be delivered to the bed of prostate. Radiotherapy will be optionally accompanied by androgen deprivation therapy.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Delayed Salvage radiotherapy (dSRT)","dSRT administered if PSA levels increase to ≥ 0.4 ng\u002Fml.\n\n66-70Gy will be delivered to the bed of prostate. Radiotherapy will be optionally accompanied by androgen deprivation therapy.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Sona Argalacsova, MD, PhD","CONTACT","+420224962219","sona.argalacsova@vfn.cz",{"name":37,"role":33,"phone":34,"phoneExt":25,"email":38},"Otakar Capoun, MD, PhD","otakar.capoun@vfn.cz",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Sona Argalacsova","Principal Investigator, Radiation oncology head","100457129","phase-3-early-salvage-therapy-for-patients-with-advanced-features-for-biochemical-relapse-after-radical-prostatectomy-for-localized-prostate-carcinoma-in-correlation-with-supposed-molecular-genetic-parameters-of-higher-aggressiveness-100457129",false,"NCT05232578","Early Salvage Therapy for Patients With Advanced Features for Biochemical Relapse After Radical Prostatectomy for Localized Prostate Carcinoma In Correlation With Supposed Molecular-genetic Parameters of Higher Aggressiveness","ESTABLISH","Inclusion Criteria:\n\n* \\> 18 years of age\n* Pathologically confirmed invasive prostate carcinoma with minimal 1 risk factor (RF) after radical prostatectomy (RP)\n* Patient refuses the adjuvant therapy after normalization of urinary function within 6 month after RP\n* Signed informed consent to participate in the study and (where necessary) consent to participate in the translational part of the research (not a requirement)\n* ECOG 0 - 1\n* pT2 and minimal 1 risk factor (RF):\n\n  * R1 (PSM), and\u002For\n  * Gleason score (4+3=7) 8-10 and\u002For ISUP grade group 3-5\n* pT3a \u002FpT3b with or without one RF\n* No evidence of suspicious pelvic lymph nodes by initial diagnostic: cN0 and\u002For pN0\n* No evidence of suspicious distant metastases by initial diagnostic: M0\n* Patient with decline of PSA level to undetectable PSA levels (\\\u003C 0,1 ng\u002Fml) or around 0,2ng\u002Fml and with another decreasing trends so that the PSA level decline within 12-24 weeks after RP to undetectable levels (\\\u003C 0,1 ng\u002Fml) and with renewed increase of PSA \\>0,2 ng\u002Fml (BCR= biochemical relapse) without any clinical relapse on PSMA PET\u002FCT\n* No hormonal therapy prior and \u002For after the radical prostatectomy\n* Patient suitable and fit for subsequent radiotherapy with high likelihood of good compliance to the follow-up\n\nExclusion Criteria:\n\n* Life expectancy (based on Charlson comorbidity index) \\\u003C 10 years\n* Patient not fit for the therapy\n* History of other cancer (other than a radically removed non-melanoma skin carcinoma)\n* Previous pelvic irradiation\n* Active immunosuppressive medication\n* History of hormone therapy prior to randomization\n* cN1 and\u002For pN1 and M1\n* PSA-persistence after RP (PSA 12-weeks after RP \\> 0.1 ng\u002Fml or no decreasing trend described in Inclusion criteria)","MALE","18 Years",{"count":53,"type":54},380,"ESTIMATED","INTERVENTIONAL",[57],"PHASE3","The primary objective of the trial is to compare the impact and safety of delayed salvage therapy (dSRT, i.e., SRT initiated at PSA values of 0.4-0.5 ng\u002Fml) to those of early salvage therapy (eSRT, i.e., at PSA levels of 0.2 ng\u002Fml) in patients with biochemical relapse after radical prostatectomy.\n\nThe secondary objective of the trial is to perform analysis of the subgroups of patients to determine which patients are most likely to benefit from dSRT\n\nExploratory objective of the trial is to determine whether selected molecular genetic parameters (172 candidate genes and molecular alterations) and known clinical parameters can be used to identify potential predictors of worse prognosis in patients with known risk factors for relapse after radical prostatectomy, thereby augmenting and refining patient stratification, optimizing their therapy, and clarifying the proper timing of multimodal therapy",[60],"Prostate Cancer",[62,63,64],"prostate carcinoma","salvage therapy","biochemical relapse","NOT_YET_RECRUITING","2022-08-02",{"date":68,"type":69},"2022-08-03","ACTUAL",{"date":71,"type":54},"2022-09",{"date":73,"type":54},"2032-12",{"name":5,"class":6}]