[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540570":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":67,"collaborators":69,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Fondazione del Piemonte per l'Oncologia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"3D group","EXPERIMENTAL","in Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle.\n\nA first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed",[13],"Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"no3D group","ACTIVE_COMPARATOR","For the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication.\n\nAt the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images.\n\nReconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy","The operation is performed using the \"Da Vinci HD\" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted.\n\nThen a radical prostatectomy is performed.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Enrico Checcucci, MD","Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+390119933632","enrico.checcucci@ircc.it",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Marco Asioli","+390119933463","marco.asioli@ircc.it",[41,56],{"facility":29,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Candiolo","Turin","10060","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],7.59812,44.95858,{"lat":52,"lon":51},[55],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},{"facility":57,"status":42,"city":58,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"AOU san Luigi Gonzaga","Orbassano",{"type":49,"coordinates":60},[61,62],7.53813,45.00547,{"lat":62,"lon":61},[65],{"name":66,"role":33,"phone":25,"phoneExt":25,"email":25},"Francesco Porpiglia, MD",{"type":68,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[70],{"name":71,"class":6},"San Luigi Gonzaga Hospital","100540570","artificial-intelligence-3d-augmented-reality-robot-assisted-radical--prostatectomy-vs-no3d-intervention-100540570",false,"NCT06318559","Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention","RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial","RIDERS","Inclusion Criteria:\n\n1. Signature of the written informed consent and consent to the use of personal data\n2. Age \\> 40 years and male sex\n3. Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2\n4. Disease with evidence of bulging or radiological T3 on pre-operative MRI\n5. Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI\n6. Absence of bulky (\\>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions\n7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy\n8. ECOG PS 0-1\n9. Life expectancy ≥ 5 years\n10. Patients motivated to preserve erection and with pre-operative sexual activity with IIEF \\>17\n11. Availability of the patient's pre-operative clinical data\n12. Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection\n\nExclusion Criteria:\n\n1. Special histotypes of prostate cancer\n2. Patients with PSA \\> 100 ng\u002Fml at diagnosis\n3. Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction\n4. Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies\n5. Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections\n6. Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and\u002For signing informed consent.","MALE","40 Years","99 Years",{"count":84,"type":85},120,"ESTIMATED","INTERVENTIONAL",[88],"NA","This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.",[91],"Cancer of Prostate",[93,91,94,95,96,97,98,99],"3D AI-AR-RARP","prostate surgery","Hyper-Accuracy 3D reconstruction (HA3DTM)","Riders","computer vision","Robot-assisted","laparoscopic radical prostatectomy","2024-03-15",{"date":102,"type":103},"2024-03-19","ACTUAL",{"date":105,"type":103},"2022-06-29",{"date":107,"type":85},"2027-12-31",{"name":5,"class":6},2]