[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"localised-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:localised-prostate-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100603342","bespoke-decision-support-for-patients-with-newly-diagnosed-localised-prostate-cancer-100603342",false,"NCT07135271","BeSpoke Decision Support for Patients With Newly Diagnosed Localised Prostate Cancer","Building and Evaluating a Stratified Prostate Cancer Pathway (BeSpoke): the Impact of BeSpoke Decision Support in Patients With Newly Diagnosed Localised Prostate Cancer - a Single-blind Randomised Controlled Trial With Mixed Method Analysis","BeSpoke","Inclusion Criteria for Patient-Participants:\n\n1. Newly diagnosed localised prostate cancer\n2. Clinically suitable for at least two of the following treatment options:\n\n   1. active surveillance\n   2. focal therapy\n   3. radical prostatectomy\n   4. external beam radiotherapy\n3. Willing and able to provide informed consent\n\nExclusion Criteria for Patient Participants:\n\n1. Unsuitable for active treatment due to very low risk prostate cancer or significant health issues.\n2. Suspicion of metastatic prostate cancer based on clinical or imaging evidence including:\n\n   1. Imaging identified suspicious lesion on bone scan, CT, whole-body MRI or PSMA-PET\u002FCT;\n   2. PSA ≥50 ng\u002FmL.\n3. Not able to provide informed consent.\n4. Insufficient English proficiency for adequate use of BeSpoke Decision Support. (Patients with support from a family member, friend or partner, to overcome lack of English proficiency will be included.)\n5. Enrolled in other localised prostate cancer studies where treatment is assigned rather than chosen by participants, e.g. PART Trial (Partial prostate Ablation vs Radical prostaTectomy)\n\nInclusion criteria for Health Care Professionals:\n\n1. Have seen BeSpoke Decision Support and spoken to patients in the intervention arm.\n2. Willing and able to provide written or electronic informed consent\n\nExclusion criteria for Health Care Professionals\n\n1\\. No experience of BeSpoke Decision Support.","ALL",{"count":19,"type":20},346,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this randomised clinical trial is to assess whether personalised treatment counselling can improve the decision-making experience in patients with a new diagnosis of localised prostate cancer. The main question it aims to answer is:\n\n• Does the Bespoke Decision Support tool reduce decisional conflict in those choosing between treatment options for localised prostate cancer?\n\nResearchers will compare the addition of the Bespoke Decision Support tool to standard treatment counselling versus standard counselling alone.\n\nPatient participants will:\n\n* Receive standard counselling with or without access to the Bespoke Decision Support tool (based on arm of randomisation), prior to making a treatment decision.\n* Answer to questionnaires regarding urinary, sexual and bowel function and decision-making outcomes before and after making a treatment decision and at 3, 6, and 12 months after initiating treatment.\n* Take part in a qualitative interview to discuss their decision-making experience\n\nHealth Care Professional participants will:\n\n• Take part in a qualitative interview to discuss their experience in providing decision support in the trial using the Bespoke Decision Support tool.",[26],"Localised Prostate Cancer",[26,28,29,30],"Patient Decision Aid","Shared Decision Making","Randomised Clinical Trial","NOT_YET_RECRUITING","2026-06-09",{"date":34,"type":35},"2026-06-10","ACTUAL",{"date":37,"type":20},"2026-06",{"date":39,"type":20},"2028-12",{"name":41,"class":42},"University College, London","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100624641","microwave-intervention-under-local-anesthesia-100624641","NCT07412275","Microwave Intervention Under Local Anesthesia","Prospective Study Evaluating the Feasibility of Focal Microwave Ablation Under Local Anesthesia in Patients With Localized Prostate Cancer","MILA","Inclusion Criteria:\n\n* Age\\>18 years old\n* Patient undergoing Koelis TMA® intervention\n* Patient is suitable for general, local anesthesia as well as sedation\n* No psychiatric illness that would prevent informed consent or optimal treatment and follow-up\n* Free, informed and written consent, dated and signed by the patient and the investigator, no later than the day of inclusion and before any examination required by the study.\n* Patient affiliated to a social security scheme or beneficiary of such a scheme in accordance with the regulations in force.\n\nExclusion Criteria:\n\n* Severe illness within the last 6 months before the screening visit, including any of the following: uncontrolled congestive heart failure, uncontrolled angina pectoris, myocardial infarction, stroke.\n* Ineligibility for a Koelis TMA® intervention\n* Contraindication to general anesthesia and deep sedation.\n* Uncontrolled coagulopathies or bleeding disorder\n* A person already participating in an interventional clinical study.\n* A person placed under judicial protection, guardianship, or legal supervision and incapable of freely giving informed consent.\n* Patient detained in an institution by medical or judicial decision.","MALE","18 Years",{"count":54,"type":20},20,[23],"This study aims to evaluate the feasibility of performing a focal Targeted Microwave Ablation (TMA) procedure using Koelis TMA® under local anesthesia in patient with localized prostate cancer.\n\nEligible patients will undergo the procedure under local anesthesia instead of general anesthesia or deep sedation as part of their routine clinical care.\n\nThe primary objective is to assess the feasibility of completing the procedure under local anesthesia, defined by the proportion of patients in whom the procedure is successfully completed under local anesthesia. Secondary objectives include the assessment of safety, ease of performance, patient satisfaction, and the use of analgesic medication.\n\nThis study is designed as a feasibility clinical investigation conducted in a routine clinical practice setting.",[26],[59,60,61,62],"Localised prostate cancer","TMA","Local anesthesia","Koelis","2026-05-15",{"date":65,"type":35},"2026-05-19",{"date":67,"type":20},"2026-06-15",{"date":69,"type":20},"2027-06-15",{"name":62,"class":71},"INDUSTRY"]