[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511230":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":32,"locations":41,"responsibleParty":61,"collaborators":36,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":36,"enrollmentInfo":75,"targetDuration":36,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":36,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"24 Gy in one fraction, urethral sparing HDR like","EXPERIMENTAL","Patients with localized prostate cancer - negative PSMA PET CT +\u002F- standard staging exams (bone scan, CT, MRI)-enrolled in this study, will be treated to prostate\u002Fprostate seminal vesicles (according to the risk group) to a total dose of 24 Gy delivered in 1 fraction, with a urethral sparing HDR like technique. For unfavorable intermediate and high-risk pts, Androgen Deprivation Therapy (ADT) will be prescribed for 6 and 24 months, respectively. The procedure will be performed in just one day, from fiducials implantation to radiation treatment delivery.",[13],"Radiation: prostate SBRT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","prostate SBRT","Patients with prostate cancer will be treated with high-dose SBRT to prostate and seminal vesicles, delivered in one fraction, sparing the urethra and generating a dose distribution similar to HDR brachytherapy",[9],[21,22],"ultrahypofractionation","extreme hypofractionation",[24,28],{"name":25,"affiliation":26,"role":27},"Nadia Di Muzio, Prof","IRCCS San Raffaele Scientific Institute","STUDY_DIRECTOR",{"name":29,"affiliation":30,"role":31},"Andrei Fodor, MD","IRCCS San Raffaele Scientific institute","STUDY_CHAIR",[33,38],{"name":29,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+390226437634",null,"fodor.andrei@hsr.it",{"name":25,"role":34,"phone":39,"phoneExt":36,"email":40},"+390226437643","dimuzio.nadia@hsr.it",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"San Raffaele Scientific Institute","RECRUITING","Milan","MI","20132","Italy","IT",{"type":51,"coordinates":52},"Point",[53,54],9.18951,45.46427,{"lat":54,"lon":53},[57,59],{"name":58,"role":34,"phone":39,"phoneExt":36,"email":40},"Nadia G Di Muzio, Prof",{"name":60,"role":34,"phone":35,"phoneExt":36,"email":37},"Fodor Andrei, M.D.",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"PRINCIPAL_INVESTIGATOR","Nadia Di Muzio","Prof.","100511230","24-gy-in-one-fraction-urethral-sparing-hdr-like-sbrt-for-prostate-cancer-100511230",false,"NCT05936736","24 Gy in One Fraction Urethral-sparing \"HDR Like\" SBRT for Prostate Cancer","24 Gy in One Fraction Urethral-sparing \"High-Dose-Rate Like\" Stereotactic Body RadioTherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study (PRO-FAST)","PRO-FAST","Inclusion Criteria:\n\n* Histological diagnosis of prostate adenocarcinoma, International Society of Urological Pathology (ISUP) grade groups 1-5\n* Patients over 18 years of age\n* Signed informed consent\n* Negative lymph nodes confirmed by imaging (PSMA PET\u002FCT and\u002For pelvic MRI with and without contrast medium) where recommended by guidelines (intermediate and high risk patients, according to National Comprehensive Cancer Network (NCCN) guidelines) in the previous 3 months\n* Clinical M0 (PSMA PET\u002FCT and\u002For bone scan and\u002For pelvic MRI with and without contrast medium in suspected patients and unfavorable intermediate and high risk patients, according to NCCN guidelines), in the previous 3 months\n* Acceptable uroflowmetry: peak urine flow index (peak flow preferably ≥ 15 ml\u002Fs), post voiding residue (PVR) ≤50 cc. If lower, acceptable if, by carrying out 3 months of neoadjuvant hormone therapy + alpha-lytic for the reduction of prostate volume, uroflowmetry is reset to at least ≥ 12 ml\u002Fs.\n* PS (ECOG) ≤2\n* No previous pelvic radiotherapy\n* Other conditions necessary for the correct execution of the proposed treatment (ability to fill in the questionnaires for the evaluation of the Quality of Life EORTC QLQ-C30, EORTC QLQ-PR25, IPSS, IIEF-5, EPIC 26)\n\nExclusion Criteria:\n\n* Serious systemic diseases\n* Psychic or other disorders that may prevent the patient from signing the informed consent\n* Previous invasive cancer, except skin cancer (excluding melanoma) unless patient free of disease for at least 3 years (e.g. carcinoma in situ of the oral cavity or bladder)\n* Lymph node disease (N1)\n* Evidence of distant metastases (M1)\n* IPSS questionnaire data \\> 20 points\n* Uroflowmetry with maximum basal flow ≤ 11 ml\u002Fsec and\u002For PVR \\>100 ml\n* Concomitant urinary\u002Fgastrointestinal inflammatory diseases (e.g. ulcerative colitis, Crohn's disease)\n* Overactive bladder\n* Impossibility of implantation of fiducials\n* Inability or refusal to place bladder catheter for simulation CT and MR\n* Inability to perform simulation MRI\n* Contraindication for hormonal treatment for patients with unfavorable intermediate, high or very high risk disease\n* Non-compliance with dose limits established in the treatment plan","MALE","18 Years",{"count":76,"type":77},70,"ESTIMATED","INTERVENTIONAL",[80],"NA","Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams, which will include prostate specific membrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with a high-dose-rate (HDR)-like urethral sparing technique. In 70 patients, acute and late toxicity, biochemical control, overall survival, cancer specific-survival, and quality of life (through specific questionnaires) will be evaluated.",[83],"Localized Prostate Carcinoma",[85,86,87,88,89,90],"Prostate Cancer","Single fraction SBRT","Urethral sparing HDR like","PSMA PET\u002FCT","Organ movement","Radiomics","2025-06-06",{"date":93,"type":94},"2025-06-08","ACTUAL",{"date":96,"type":94},"2023-11-08",{"date":98,"type":77},"2030-05",{"name":5,"class":6},1]