[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503244":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":48,"collaborators":28,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":28,"enrollmentInfo":60,"targetDuration":28,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":28,"overallStatus":32,"whyStopped":28,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Fondazione del Piemonte per l'Oncologia","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Patients with unilateral prostate cancer","EXPERIMENTAL",[12],"Procedure: Robotic hemi-prostatectomy with urethral preservation",[14],{"type":15,"name":16,"description":16,"armGroupLabels":17,"otherNames":18},"PROCEDURE","Robotic hemi-prostatectomy with urethral preservation",[9],[19],"Partial prostatectomy",[21],{"name":22,"affiliation":5,"role":23},"Francesco Porpiglia","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":28,"email":29},"CONTACT","+39 011 9933921",null,"francesco.porpiglia@unito.it",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Candiolo","TO","10060","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],7.59812,44.95858,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":27,"phoneExt":28,"email":47},"Enrico Checcucci","checcu.e@hotmail.it",{"type":23,"investigatorFullName":22,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Prof.","100503244","robotic-hemi-prostatectomy-with-urethral-preservation-in-low-and-intermediate-risk-monolateral-prostate-cancer-100503244",false,"NCT05832736","Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer","Robotic Hemi-Prostatectomy With Urethral Preservation in Low and Intermediate Risk Monolateral Prostate Cancer: a Prospective Idea, Development, Exploration, Assessment and Long-term Follow-up (I.D.E.A.L.) Trial","RETURN","Inclusion Criteria:\n\n* Signature of the informed consent and consent to the use of personal data\n* Prostate Specific Antigen (PSA) \\\u003C 20 ng\u002FmL\n* Unilateral organ-confined disease on MRI (performed according to ESUR recommendations and reported according to PiRads V.2) or PET-PSMA (performed according to the recommendations of the EANM and reported according to \"EANM standardized reporting guidelines v1.0 for PSMA-PET\")\n* Histological diagnosis of acinar-type prostate cancer unilateral on target biopsy and\u002For standard biopsy with ISUP \\\u003C 3 and ipsilateral on imaging investigations\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n* Life expectancy ≥ 5 years\n* Availability of the patient's pre-operative clinical data\n* Patients must be available to carry out the follow-up visits defined by the protocol\n* Absence of retroperitoneal, lymph nodal, bone or visceral metastatic lesions\n* Patients eligible for robot-assisted radical prostatectomy\n\nExclusion Criteria:\n\n* Special histotypes of prostate cancer\n* Patients with PSA \\> 20 ng\u002Fml at diagnosis\n* Impossibility to perform MRI (with pacemakers, claustrophobia…) or PET-PSMA\n* Previous prostate surgery (TURP, adenomectomy)\n* Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies\n* Serious underlying disease or uncontrolled medical condition including active and uncontrolled infections\n* Patients with dementia or psychiatric illness that limit compliance with study requirements or that could prevent understanding and\u002For signing the informed consent.","MALE","40 Years",{"count":61,"type":62},36,"ESTIMATED","INTERVENTIONAL",[65],"NA","On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy\u002Fhemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients.\n\nThe hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (PSM) and biochemical recurrence of the disease (BCR), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).",[68],"Prostate Cancer","2023-09-22",{"date":71,"type":72},"2023-09-26","ACTUAL",{"date":74,"type":72},"2023-04-12",{"date":76,"type":62},"2028-10",{"name":5,"class":6},1]