[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582648":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":24,"centralContacts":25,"locations":34,"responsibleParty":51,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":24,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":24,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"single arm","EXPERIMENTAL","All patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance will undergo:\n\n* PSMA-PET\u002FMRI → Evaluation of intraprostatic PSMA expression (SUVmax, PRIMARY-likert score).\n* Whole Exome Sequencing (WES) → Genomic analysis of diagnostic biopsies. Multiplex Immunohistochemistry (IHC) → Study of biomarkers on diagnostic biopsies.\n\nConfirmation biopsy one year after diagnosis, according to international guidelines.",[13],"Procedure: mpMRI-targeted confirmatory biopsy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","mpMRI-targeted confirmatory biopsy","mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines",[9],[21,22,23],"18F-PSMA PET\u002FMRI","WES and spatial transcriptomics on the diagnostic biopsy specimens","Multiplex immunohistochemistry on the diagnostic biopsy specimens",null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Giorgio Gandaglia","CONTACT","+39 0226438068","gandaglia.giorgio@hsr.it",{"name":32,"role":28,"phone":24,"phoneExt":24,"email":33},"Lucia Dambrosio","dambrosio.lucia@hsr.it",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":39,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"IRCCS Ospedale San Raffaele","RECRUITING","Milan","Italy","20132","IT",{"type":43,"coordinates":44},"Point",[45,46],9.18951,45.46427,{"lat":46,"lon":45},[49,50],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},{"name":32,"role":28,"phone":24,"phoneExt":24,"email":33},{"type":52,"investigatorFullName":27,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Medical Doctor","100582648","biological-markers-and-advanced-imaging-for-prostate-cancer-progression-in-active-surveillance-100582648",false,"NCT06866041","Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance","Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance","PSMA-AS","Inclusion Criteria:\n\n* Histologically proven low-risk PCa (PSA ≤10 ng\u002Fml; clinical stage ≤T2a, and biopsy ISUP GG 1)\n* Non-metastatic status at study inclusion (patient enrollment).\n* No prior or concomitant androgen deprivation therapy\n* Ability to understand a written informed consent and willingness to sign it.\n\nExclusion Criteria:\n\n* Unable to tolerate a PSMA-PET scan\n* Unwillingness to be managed with AS\n* Receipt of neoadjuvant or curative-intent therapies\n* Pacemaker\n* Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy","MALE","45 Years","80 Years",{"count":66,"type":67},74,"ESTIMATED","INTERVENTIONAL",[70],"NA","This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:\n\n* PSMA PET with calculation of SUVmax and PRIMARY-Likert score\n* Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies\n* Immunohistochemistry on diagnostic prostate biopsies\n* Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.",[73],"Low-Risk Prostate Cancer","2025-05-13",{"date":76,"type":77},"2025-05-16","ACTUAL",{"date":79,"type":77},"2025-05-07",{"date":81,"type":67},"2030-03",{"name":5,"class":6},1]