[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654992":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":45,"studyPopulation":45,"armGroups":48,"interventions":61,"overallOfficials":45,"centralContacts":70,"locations":45,"responsibleParty":76,"collaborators":45,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":45,"enrollmentInfo":90,"targetDuration":45,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":106,"whyStopped":45,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":45},{"fullName":5,"class":6},"University of British Columbia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Pathologic metastatic yield","The ratio of metastatic (histopathologically confirmed) lymph nodes to the total number of lymph nodes removed during salvage lymph node dissection.","2-4 weeks post-op",[14,17,21,25],{"measure":15,"description":16,"timeFrame":12},"PSMA PET\u002FCT and pathologic node concordance","Concordance between pre-operative PSMA-PET\u002FCT-identified nodal lesions and histopathological confirmation of metastatic lymph nodes, evaluated at the nodal region level and, where feasible, at the individual node level.",{"measure":18,"description":19,"timeFrame":20},"Biochemical response at Week 6","* Biochemical control considered as PSA level \\\u003C0.2 after primary prostatectomy\n* Biochemical control considered as PSA level \\\u003C2 above nadir after primary radiotherapy\n* Proportion of participants achieving PSA decline \\>50%\n* Proportion of participants achieving PSA decline \\>90%","Surgery to 6 week post-op",{"measure":22,"description":23,"timeFrame":24},"Patient-reported quality-of-life outcomes","Patient-reported health-related quality of life will be assessed using the Expanded Prostate Cancer Index Composite 26-item short form (EPIC-26). The EPIC-26 produces five domain scores: urinary incontinence, urinary irritative\u002Fobstructive, bowel, sexual, and hormonal. Each domain score ranges from 0 to 100, with higher scores indicating better function and health-related quality of life (fewer symptoms or less bother).\n\nOutcomes will include:\n\n1. Change from baseline in each EPIC-26 domain score at each follow-up timepoint.\n2. Between-group differences in EPIC-26 domain scores over time.\n3. Proportion of participants experiencing clinically meaningful deterioration in each domain, defined as a decrease from baseline meeting a prespecified, validated minimally important difference (6-9 points for urinary incontinence, 5-7 for urinary irritative\u002Fobstructive, 4-6 for bowel, 10-12 for sexual, and 4-6 for hormonal scores)","Date of surgery until 2 years post-operative",{"measure":26,"description":27,"timeFrame":28},"Long-term biochemical and clinical outcomes at 2 years post-lymph node dissection","* Time to PSA failure (biochemical failure), defined as time from sLND to first occurrence of PSA failure (confirmed rise above nadir\u002Fthreshold)\n* Time to recurrence-directed imaging prompted by biochemical and\u002For clinical suspicion\n* Time to initiation of salvage treatment, defined as time from sLND to start of first salvage therapy for recurrent\u002Fprogressive disease, such as salvage radiotherapy and\u002For systemic therapy (ADT ± ARPI\u002Fother systemic agents)\n* Metastasis-free survival (MFS), defined as time from sLND to first evidence of distant metastasis on imaging following standard-of-care principles or death from any cause, whichever occurs first","Surgery to 2 years post-operative",[30,34,37],{"measure":31,"description":32,"timeFrame":33},"Pattern of recurrence on PSMA-PET\u002FCT at first biochemical recurrence\u002Fpersistence","* Proportion of participants with in-field nodal recurrence, defined as PSMA-avid lymph nodes within the prior surgical dissection template\n* Proportion of participants with out-of-field regional recurrence, defined as PSMA-avid pelvic or paraaortic nodes outside the prior dissection template\n* Proportion of participants with distant recurrence, defined as extra-pelvic nodal, osseous, or visceral PSMA-avid lesions","Surgery until 2 years post-operative",{"measure":35,"description":36,"timeFrame":33},"Disease burden at biochemical persistence:","-Number of PSMA-avid lesions per participant on PSMA-PET\u002FCT, compared descriptively between treatment arms",{"measure":38,"description":39,"timeFrame":33},"PSMA-PET\u002FCT detection rate at biochemical persistence:","-Proportion of participants with at least one PSMA-avid lesion identified on PSMA-PET\u002FCT",{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":45,"timePerspective":45,"maskingInfo":46},"RANDOMIZED","PARALLEL","Prospective, randomized, open-label, two-arm, parallel-group Phase II clinical trial.","TREATMENT",null,{"masking":47,"maskingDescription":45,"whoMasked":45},"NONE",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Salvage pelvic lymph node dissection","ACTIVE_COMPARATOR","Salvage radioguided pelvic lymph node dissection",[54],"Other: Salvage pelvic lymph node dissection",{"label":56,"type":57,"description":58,"interventionNames":59},"PSMA technetium assisted radioguided salvage lymph node dissection","EXPERIMENTAL","Participants will be administered PSMA technetium pre-operatively to assess effect of radioguided lymph node dissection on oncologic, quality of life and functional outcomes",[60],"Procedure: PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection",[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":45},"PROCEDURE","PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection","Participants in the intervention arm will receive PSMA 99mTc-MIP-1404 radioguided salvage lymph node dissection.",[56],{"type":6,"name":50,"description":68,"armGroupLabels":69,"otherNames":45},"Salvage standard lymph node dissection",[50],[71],{"name":72,"role":73,"phone":74,"phoneExt":45,"email":75},"Miles P Mannas, MD, MSc, FRCSC","CONTACT","604-875-5003","miles.mannas@ubc.ca",{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Miles Mannas","Principal Investigator","100654992","phase-2-radioguided-salvage-pelvic-node-dissection-in-oligometastatic-prostate-cancer---salvage-100654992",false,"NCT07807293","Radioguided Salvage Pelvic Node Dissection in Oligometastatic Prostate Cancer - SALVAGE","Radioguided SALVAGE Lymph Node Dissection In Oligometastatic Prostate Cancer: A Prospective Randomized controLled Trial Comparing 99mTc-PSMA-radioguided Salvage Lymph Node Dissection With PSMA-PET Based Lymph Node Dissection (The SALVAGE Study)","SALVAGE","Inclusion Criteria:\n\n* Adult\n* Males\n* Oligorecurrent prostate cancer following definitive treatment who demonstrate a maximum of four positive lymph nodes within no more than three nodal basins on 68Ga-PSMA-PET\u002FCT Considered suitable candidates for salvage surgery.\n\nExclusion Criteria:\n\n* Not meeting inclusion criteria","MALE","18 Years",{"count":91,"type":92},62,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","The goal of this clinical trial is to learn whether radioguided surgery can help surgeons find and remove lymph nodes containing prostate cancer in men whose cancer has returned in a small number of lymph nodes after previous prostate cancer treatment. It will also learn about the safety of this approach, changes in prostate-specific antigen (PSA), quality of life, and longer-term cancer outcomes.\n\nThe main questions the study aims to answer are:\n\nDoes radioguided surgery increase the proportion of removed lymph nodes that are found to contain prostate cancer compared with standard surgery? How well do the lymph nodes identified on imaging scans match the cancer found when the removed lymph nodes are examined in the laboratory? Does radioguided surgery lead to a greater decrease in PSA after surgery? What side effects or surgical complications occur? How does each type of surgery affect quality of life, the need for additional cancer treatment, and the risk of the cancer spreading? Researchers will compare radioguided salvage lymph node surgery with standard salvage lymph node surgery. Salvage lymph node surgery is an operation to remove lymph nodes after prostate cancer has returned.\n\nParticipants will:\n\nBe randomly assigned to one of two treatment groups. Have surgery to remove lymph nodes suspected of containing prostate cancer. If assigned to the radioguided group, receive a radioactive PSMA-targeting tracer called 99mTc-MIP-1404, undergo a SPECT\u002FCT scan, and have surgery the following day. During surgery, the surgeon will use a handheld detector to locate lymph nodes that have taken up the tracer.\n\nIf assigned to the standard-surgery group, have surgery planned using a standard PSMA-PET\u002FCT scan, without the handheld radioguidance procedure.\n\nHave PSA blood tests, assessments for complications, and quality-of-life questionnaires after surgery.\n\nBe followed for cancer outcomes for up to two years.",[98,99],"Prostate Cancer","Oligometastatic",[101,102,103,104,105],"prostate cancer","PSMA","radioguided surgery","olgiometastasis","Recurrent","NOT_YET_RECRUITING","2026-09-02",{"date":109,"type":110},"2026-09-08","ACTUAL",{"date":112,"type":92},"2026-11",{"date":114,"type":92},"2031-12",{"name":5,"class":6}]