[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Massimo Valerio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100658115","tractography-guided-nerve-sparing-in-prostate-cancer-100658115",false,"NCT07847385","Tractography-Guided Nerve-Sparing in Prostate Cancer","PRO-TRACT: Prostate Tractography for Optimized Nerve-Sparing - A Pilot Study","PRO-TRACT","Inclusion Criteria:\n\n* Histological confirmed diagnosis of prostate cancer (PCa) based on prostate biopsy\n* Multidisciplinary indication for radical prostatectomy, validated by the Urology Tumor Board\n* No prior treatment of prostate cancer\n* Capacity to provide informed consent\n\nExclusion Criteria:\n\n* Unwillingness to participate.\n* Pre-existing impaired sexual function before surgery (IIEF5 Score of ≤21)\n* Diagnosis of neuropathy\n* Inability to comply with study procedure (e.g. due to language barriers, psychological disorders, dementia, anxiety\u002Fclaustrophobia during pelvic MRI etc.) or medical contraindications to MRI","MALE","18 Years",{"count":20,"type":21},23,"ESTIMATED","INTERVENTIONAL",[24],"NA","Radical prostatectomy (RP) is an effective treatment leading to a high rate of oncological control. However, despite advances in robot-assisted RP, the genito-urinary function, especially erectile function and urinary continence, may be significantly impaired after surgery.\n\nOur study aims to characterize and map the nerve fibers surrounding the prostate before and after surgery using diffusion tensor magnetic resonance imaging (DTI), a non-invasive magnetic resonance imaging (MRI) technique. This relatively new technology, combined with the 3D tractography software, will allow us to create a personalized 3D model of the periprostatic nerves. This virtual model will help us to assess the nerve bundles and how the surgery impacts their integrity. DTI and 3D reconstruction will be performed before and 6 months after surgery.\n\nThe pre-surgery 3D virtual model will be overlaid and mapped onto the intraoperative surgical view, providing the surgeon with a visual guide of the nerve fiber organization. At the post-surgery level, the 3D virtual model of the nerve bundles will be compared to the pre-surgery model. Post-treatment changes at 6 months may help assess nerve preservation and their relationship with erectile (dys)function.\n\nThe main questions the clinical study aims to answer are:\n\n1. Post-treatment DTI-Tractography parameter changes at 6 months may help assess nerve recovery and their relationship with erectile (dys)function (PROMs - IIEF-5 score)\n2. Post-treatment DTI-Tractography parameter changes at 6 months may help assess their relationship with urinary function\n3. At the post-surgery level, the 3D virtual model of the nerve bundles will be compared to the pre-surgery 3D model.\n4. The pre-surgery 3D virtual model will be overlaid and mapped onto the intraoperative surgical view, providing the surgeon with a visual guide of the nerve fiber organization (mean surgery time, surgeon feedback assessment, etc., will be evaluated.) Tumor location based on the 3D model will also be explored.",[27,28,29],"Prostate Cancer","Erectile Dysfunction Following Radical Prostatectomy","Urinary Incontinence Following Surgical Procedure",[31,32,33,34,35,36,37,38,39,40],"Prostate cancer","Robot-assisted Prostatectomy","Erectile dysfunction","Nerve-sparing","Diffusion tensor imaging","Tractography","Augmented reality","3D virtual model of nerve fibers for surgical guidance","Low-risk prostate cancer","Intermediate-risk prostate cancer","RECRUITING","2026-09-25",{"date":44,"type":45},"2026-09-29","ACTUAL",{"date":47,"type":45},"2026-09-01",{"date":49,"type":21},"2028-04-01",{"name":51,"class":52},"Massimo Valerio","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":53},"100656477","spectra-intraoperative-hyperspectral-imaging-for-prostate-cancer-100656477","NCT07826858","SPECTRA: Intraoperative Hyperspectral Imaging for Prostate Cancer","SPECTRA","Inclusion Criteria:\n\n* Histological diagnosis (biopsy) of Pca\n* Prostate volume \\\u003C 100 cm3 (measured on preoperative MRI) for a smooth acquisition with the hyperspectral device\n* Capable of forming his own views\n\nExclusion Criteria:\n\n* Unwilling to participate.\n* Inability to follow study procedures, for example due to language problems, psychological disorders, dementia, etc.",{"count":62,"type":21},26,[24],"Radical prostatectomy (RP) is currently one of the gold standard of care in managing localized prostate cancer (Pca). However, despite advances in Robot-Assisted RP (RARP), cancer cells may still be found (up to 42%) at the edge of the removed prostate specimen, commonly referred as Positive Surgical Margins (PSM). PSM are well-known risk factors of adverse oncological outcomes (biochemical recurrence).\n\nIt is therefore essential to characterize intraoperatively the tumor extent. In RARP, the leading intraoperative margin assessment (IMA) technique, NeuroSAFE is based on Intra-operative frozen section (IFS) of both prostate lateral sides sampled at 3-5 mm intervals. However, despite proven oncological benefit, adoption is still limited to expert centers due to a prolonged operative time, loss of integrity of the surgical specimen for definitive histopathological analysis, omission of regions (apex, base), and logistical complexity (trained uropathologist, cryostat…).\n\nWith this prospective single-center project, we wish to explore the use of non-invasive optical imaging technology, HyperSpectral Imaging (HSI), as a reliable alternative for examination of the ex-vivo prostate specimen to\n\n1. Distinguish normal versus tumor tissue at the surgical margin in fresh specimen.\n2. Quantify whether HSI can be integrated into the intraoperative workflow (feasibility), thus, image acquisition time and inference time should then be evaluated.",[66,67,68],"Localized Prostate Cancer","Positive Surgical Margin","Hyperspectral Imaging",[70,71,72,73,74,75],"Radical prostatectomy","Localized prostate cancer","Positive Surgical Margins","HyperSpectral Imaging (HSI)","Hyperspectral Reflectance Imaging","Resection margins","2026-09-14",{"date":78,"type":45},"2026-09-17",{"date":80,"type":45},"2026-08-01",{"date":82,"type":21},"2027-12-31",{"name":51,"class":52},""]