[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"low-risk-prostate-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:low-risk-prostate-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,84],{"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":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100525078","the-precision-study-3-fractions-of-prostate-sbrt-and-raypilot-hypocath-image-guidance-100525078",false,"NCT06117059","The PRECISION Study: 3 Fractions of Prostate SBRT and RayPilot HypoCath Image Guidance","The PRECISION Study: A Phase II Study of 3 Fractions of Prostate SBRT With RayPilot System and HypoCath Image Guidance for Men With NCCN Low or Intermediate Risk Prostate Cancer","PRECISION","Inclusion Criteria:\n\n* low and favorable intermediate NCCN Criteria patients\n* Prostate volume under 80cc\n* IPSS under 20\n* Q-max above 10cc per second and urinary residual less than 150mls\n* No TURP\n* No hip replacements\n* No previous radiotherapy to the pelvis\n* No active second malignancy except skin SCC or BCC for the last 2 years\n* No history of inflammatory bowel disease\n* No co-morbid illness that would make compliance to treatment difficult\n* Able to give informed consent\n\nExclusion Criteria:\n\n* T3a or above\n* Gleason 4+3=7\n* PSA\\>20ng\u002Fml","MALE",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","The investigators want to investigate whether it is possible to reduce the number of curative radiotherapy doses from 5 to only 3 for men with localized early prostate cancer. The aim of the study is to ensure that the side effects of the 3-dose treatment are the same or potentially lower than those already published when using the 5-dose treatment as used in the UK PACE-B trial (NCT01584258). The name of this type of radiotherapy is Stereotactic Body Radiotherapy (SBRT) or participants may see it referred to as Stereotactic Ablative Radiotherapy (SABR). The study is a two-stage single arm Phase II study open to those Centres that use the RayPilot HypoCath tumour tracking system (Micropos Medical). This commercially available system was not available at the time of the original PACE-B study. The system acts like a Global Positioning Device (GPS) to continuously track the prostate position during radiotherapy. If the prostate moves more than 2mm (about 0.08 in) from its intended position during the treatment, then the radiotherapy team are alerted, and the treatment halted until the prostate moves back into the correct position. The ability to understand exactly where the prostate is throughout the treatment ensures the intended dose hits the cancer and does not accidentally increase the dose to the nearby bladder and rectum. The system is a modification of a standard urinary catheter which sits within the bladder with the GPS placed within the wall of the catheter as it passes through the prostate. The investigators are not testing the system as it is commercially available but using it to improve the accuracy of radiotherapy delivery, reducing the number of days of treatment, minimizing side effects and helping ease the burden on busy radiotherapy Departments.",[26,27,28],"Localized Prostate Cancer","Low Risk Prostate Cancer","Intermediate Risk Prostate Cancer",[30,31,32,33,34,35,36],"SBRT","SABR","PROSTATE CANCER","RayPilot","HypoCath","Continuous tracking","3 fractions","RECRUITING","2026-01-08",{"date":40,"type":41},"2026-01-12","ACTUAL",{"date":43,"type":41},"2024-11-01",{"date":45,"type":20},"2027-11-01",{"name":47,"class":48},"NHS Lothian","OTHER_GOV",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":61,"studyType":62,"phases":4,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100605906","study-of-psma-petct-imaging-to-help-select-men-with-low-risk-prostate-cancer-for-active-surveillance-100605906","NCT07168616","Study of PSMA PET\u002FCT Imaging to Help Select Men With Low-Risk Prostate Cancer for Active Surveillance","Prospective Evaluation of Istanbul PSMA PET\u002FCT Criteria for Selecting Candidates for Active Surveillance in Low-Risk Prostate Cancer","I-SELECT","Inclusion Criteria:\n\n* mpMRI performed within 3 months prior to enrollment\n* Systematic or MRI-targeted prostate biopsy performed\n* Biopsy-confirmed ISUP Grade 1 low-risk PCa\n* Prostate biopsy report specifying tumor localization and number of positive cores\n* Meets AS criteria: ISUP 1, PSA ≤10 ng\u002FmL, PSAd \\>0.15 ng\u002FmL², clinical stage cT1c-T2a, ≤3 positive cores\n* Life expectancy ≥10 years\n* No prior PSMA PET imaging\n* No evidence of extra-prostatic disease on mpMRI\n* Signed informed consent for study procedures\n\nExclusion Criteria:\n\n* High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1\u002F2 mutations if available)\n* Prior prostate cancer treatment or prostate surgery\n* MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis\n* History of pelvic radiotherapy\n* Life expectancy \\\u003C10 years\n* Severe renal impairment\n* Inability to comply with follow-up schedule","18 Years",{"count":60,"type":20},201,"2 Years","OBSERVATIONAL","This is a multicenter, prospective diagnostic accuracy study evaluating the Istanbul PSMA PET\u002FCT Criteria (IPPC) for selecting patients with biopsy-confirmed low-risk prostate cancer (ISUP Grade 1) for active surveillance (AS). The study integrates delayed Ga-68 PSMA PET\u002FCT imaging into the diagnostic pathway to refine patient stratification, minimize overtreatment and potentially reduce unnecessary biopsies and MRI, or exposing high-risk individuals to the danger of cancer progression if left untreated scans.",[27,65],"Clinically Significant Prostate Cancer",[67,68,69,70,71,72],"PSMA PET\u002FCT","Low risk prostate cancer","active surveillance","prostate cancer","clinically significant prostate cancer","Diagnosis of prostate cancer","2025-09-11",{"date":75,"type":41},"2025-09-15",{"date":77,"type":41},"2025-09-01",{"date":79,"type":20},"2028-06-01",{"name":81,"class":82},"Istanbul University - Cerrahpasa","OTHER",10,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":49},"100582648","biological-markers-and-advanced-imaging-for-prostate-cancer-progression-in-active-surveillance-100582648","NCT06866041","Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance","Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance","PSMA-AS","Inclusion Criteria:\n\n* Histologically proven low-risk PCa (PSA ≤10 ng\u002Fml; clinical stage ≤T2a, and biopsy ISUP GG 1)\n* Non-metastatic status at study inclusion (patient enrollment).\n* No prior or concomitant androgen deprivation therapy\n* Ability to understand a written informed consent and willingness to sign it.\n\nExclusion Criteria:\n\n* Unable to tolerate a PSMA-PET scan\n* Unwillingness to be managed with AS\n* Receipt of neoadjuvant or curative-intent therapies\n* Pacemaker\n* Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy","45 Years","80 Years",{"count":95,"type":20},74,[23],"This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:\n\n* PSMA PET with calculation of SUVmax and PRIMARY-Likert score\n* Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies\n* Immunohistochemistry on diagnostic prostate biopsies\n* Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.",[99],"Low-Risk Prostate Cancer","2025-05-13",{"date":102,"type":41},"2025-05-16",{"date":104,"type":41},"2025-05-07",{"date":106,"type":20},"2030-03",{"name":108,"class":82},"Università Vita-Salute San Raffaele"]