[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534429":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":60,"collaborators":64,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":26,"eligibilityCriteria":82,"healthyVolunteers":79,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-port extraperitoneal RARP","EXPERIMENTAL","Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques",[13],"Procedure: Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques",{"label":15,"type":16,"description":17,"interventionNames":18},"Multi-port transperitoneal RARP","ACTIVE_COMPARATOR","Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques",[19],"Procedure: Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques","Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy（VIP） techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques","Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Shancheng Ren, MD\u002FPhD","CONTACT","139 1779 3885","renshancheng@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Yi fan Chang","13661652533","13661652533@163.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Changzheng hospital","RECRUITING","Shanghai","Shanghai Municipality","201109","China","CN",{"type":51,"coordinates":52},"Point",[53,54],121.45806,31.22222,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":36},"Shancheng Ren, PhD","13917793885",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ren Shancheng","Professor，Chief of Urology",[65,67,69,71,73,75],{"name":66,"class":6},"Shanghai Zhongshan Hospital",{"name":68,"class":6},"ShuGuang Hospital",{"name":70,"class":6},"Eastern Hepatobiliary Surgery Hospital",{"name":72,"class":6},"The First Affiliated Hospital of Guangzhou Medical University",{"name":74,"class":6},"Sir Run Run Shaw Hospital",{"name":76,"class":6},"Sichuan Provincial People's Hospital","100534429","extraperitoneal-single-port-robotic-assisted-radical-prostatectomy-rarp-versus-transperitoneal-multi-port-rarp-in-the-treatment-of-prostate-cancer-sino-top-100534429",false,"NCT06238713","Extraperitoneal SINgle-port rObotic-assisted Radical Prostatectomy (RARP) Versus Transperitoneal Multi-port RARP in the Treatment Of Prostate Cancer (SINO-TOP)","Inclusion Criteria:\n\n1. Men aged 18 years ≤ age ≤ 75 years;\n2. Prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of T1c to T2b,N0M0;.\n3. Gleason Score\\\u003C8.\n4. PSA\\\u003C20ng\u002Fml.\n5. Pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma;\n6. The patient has healthy sexual function before surgery and intention for sexual activities after surgery;\n7. Physiological condition acceptable for laparoscopic surgery;\n8. Willing to cooperate and complete the study follow-up and related examinations;\n9. The subject or his agent voluntarily participates in this trial and signs the written informed consent;\n10. The questionnaire can be completed in Chinese.\n11. The patient has been informed of the trial;\n\nExclusion Criteria:\n\n1. High-risk and non-organ localized prostate cancer (clinical stage ≥ T2c, GS ≥ 8, PSA \\> 20ng\u002Fml);\n2. Special type of prostate cancer， such as neuroendocrine etc.;\n3. History of previous abdominal surgery and radiotherapy which may affect abdominal incision and Port placement;\n4. Recent surgery of rectum, perianal abscess or around fistula and perineal area;\n5. Patients who have undergone previous electro-prostatectomy\u002Fenucleation of the prostate;\n6. Non-recurrent patients with less than 12 months of follow-up;\n7. ECOG\\>1.\n8. Combination of other systemic tumors;\n9. had received any type of preoperative antitumor therapy;\n10. Suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function;\n11. Participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months;\n12. Other conditions that the researchers believe may affect the experimental results or are unethical;","MALE","18 Years","75 Years",{"count":87,"type":88},480,"ESTIMATED","INTERVENTIONAL",[91],"NA","This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.",[94,95],"Prostate Adenocarcinoma","Localized Prostate Carcinoma",[97,98,99,100,101,102,103],"Prostate Cancer","Robotic-assisted Radical Prostatectomy","da Vinci surgical robot","Potency","Non-inferiority","RCT","Continence","2024-08-02",{"date":106,"type":107},"2024-08-05","ACTUAL",{"date":109,"type":107},"2024-01-08",{"date":111,"type":88},"2025-12",{"name":5,"class":6},1]