[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-recurrent-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-recurrent-prostate-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100531626","alpha-radiation-emitters-device-dart-for-the-treatment-of-non-metastatic-locally-recurrent-prostate-cancer-100531626",false,"NCT06202248","Alpha Radiation Emitters Device (DaRT) for the Treatment of Non-Metastatic Locally Recurrent Prostate Cancer.","A Feasibility and Safety Study of Focal Interstitial Radiotherapy Using Diffusing Alpha Emitters Radiation Therapy (DaRT) Seeds in Men With Non-metastatic Locally Recurrent Prostate Cancer.","Inclusion Criteria:\n\n* Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting\n* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1\n* Patient being considered for focal salvage brachytherapy\n* Lesion size ≤ 3 cm in the longest diameter\n* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds\n* Pre-salvage PSA level (rPSA) below \\\u003C10 ng\u002Fml\n* Age ≥ 18 years old\n* ECOG Performance Status Scale ≤ 2\n* Subjects' life expectancy is more than 6 months\n* Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate\u002Fwhole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0\n* Platelet count ≥100,000\u002Fmm3\n* Subjects are willing and able to sign an informed consent form.\n\nExclusion Criteria:\n\n* N1 or M1 disease\n* Prior TURP or prostate surgery\n* Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI)\n* Inability to undergo general or spinal anesthesia\n* Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit 0.\n* Previous diagnosis of other malignancy \\\u003C 3 years of enrollment (excluding non-melanomatous skin cancer)\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT\n* High probability of protocol non-compliance (in opinion of investigator)\n* Subjects not willing to sign an informed consent\n* Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)","MALE","18 Years","120 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a multi-center clinical study enrolling up to 10 participants. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. Secondary objectives are to 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds.\n\nFeasibility will be determined according to the rate of successful placement of DaRT seeds via imaging \\[Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.",[27,28],"Non-metastatic Prostate Cancer","Locally Recurrent Prostate Cancer",[30,31,32,33],"recurrent prostate cancer.","Alpha emitting radiation","Alpha DaRT","Prostate cancer","RECRUITING","2026-06-15",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":38},"2024-03-12",{"date":42,"type":21},"2027-06",{"name":44,"class":45},"Alpha Tau Medical LTD.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100615314","alpha-radiation-emitters-device-dart-for-the-treatment-of-locally-recurrent-prostate-cancer-100615314","NCT07290998","Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Recurrent Prostate Cancer","A Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Locally Recurrent Prostate Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven prostate adenocarcinoma\n* Biochemical recurrence by the Phoenix definition (PSA nadir + 2 ng\u002FmL) and confirmed by a pre-treatment biopsy.\n* Patients eligible for focal salvage brachytherapy\n* Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum\n* Pre-salvage PSA level (rPSA) \\\u003C 10 ng\u002Fml\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 OR by multiparametric MRI according RECIST v1.1 (Patients who were classified as stage II according to MRI)\n* Lesion size ≤ 5 cm in the longest diameter\n* ECOG Performance Status Scale 0 - 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥ 40 years old\n* Subjects are willing and able to sign an informed consent form\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) for 3 months after DaRT insertion\n\nExclusion Criteria:\n\n* Concomitant immunotherapy within the past 4 weeks.\n* Patients with lymph node or metastatic disease\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Patients with prior surgery or low-dose-rate (LDR) brachytherapy as the primary treatment of their prostate cancer.\n* \\[For Stage 1 of the study only\\] Patients with prior high-dose-rate (HDR) brachytherapy or stereotactic body radiation therapy (SBRT) as the primary treatment of their prostate cancer.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation, and for 3 months after DaRT insertion\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).","40 Years",{"count":56,"type":21},12,[24],"This is a multi-center clinical study enrolling up to 12 participants . The primary objective of the study is to evaluate the safety of Alpha DaRT for the treatment of locally recurrent prostate cancer . The secondary objectives of the study is to evaluate the efficacy of the Alpha DaRT sources in locally recurrent prostate cancer patients assessed by biochemical and clinical evaluation of disease progression as well as overall survival",[60,61,28],"Prostate Cancer","Recurrent Prostate Cancer",[63,60,61],"Alpha radiation","NOT_YET_RECRUITING","2026-03-31",{"date":67,"type":38},"2026-04-06",{"date":69,"type":21},"2026-05",{"date":71,"type":21},"2029-05",{"name":44,"class":45},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":46},"100291400","focal-radiotherapy-for-previously-treated-prostate-cancer-patients-100291400","NCT03073278","Focal Radiotherapy for Previously Treated Prostate Cancer Patients","Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate","Inclusion Criteria:\n\n* Men \\> 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men \\> 5yrs from EBRT if neo-adjuvant and\u002For adjuvant androgen deprivation therapy (ADT) also used\n* Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)\n* Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.\n* Life expectancy at least 10yrs from time of SBRT\n* PSA \\\u003C 10\n\nExclusion Criteria:\n\n* Recurrence in immediate proximity to rectum (unless able to have hydrogel)\n* Grade 3 or more toxicity from previous EBRT\n* Contra-indicated for fiducial insertion\n* GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)",{"count":81,"type":21},36,[24],"To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.",[28],"2026-02-04",{"date":87,"type":38},"2026-02-06",{"date":89,"type":38},"2017-04-24",{"date":91,"type":21},"2027-03-31",{"name":93,"class":94},"Royal North Shore Hospital","OTHER"]