[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541818":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":21,"overallOfficials":37,"centralContacts":44,"locations":54,"responsibleParty":86,"collaborators":21,"id":88,"slug":21,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":21,"enrollmentInfo":97,"targetDuration":21,"studyType":100,"phases":21,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":56,"whyStopped":21,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Fondazione del Piemonte per l'Oncologia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number, type and frequency of DDR and MMR germline\u002Fsomatic alterations","Evaluation of the frequency, number and type of DDR and MMR germline\u002Fsomatic alterations in the study population","24 months",{"measure":14,"description":15,"timeFrame":16},"Changes in PSA levels in the 3 cohorts","Evaluation of PSA levels (baseline versus follow-up) in the 3 cohorts compared with radiological assessment","36 months",[18],{"measure":19,"description":20,"timeFrame":16},"Number of patient-derived preclinical models","Number of patient-derived preclinical models (primary 2D cell lines, organoids or PDXs)",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","In this study 150 patients will be enrolled in cohort A, 100 patients in cohort B and 100-150 patients in Cohort C.\n\nConsidering the known frequency of DDR and MMR germline\u002Fsomatic alterations, it is expected to see:\n\n* 15-23 patients with germline\u002Fsomatic DDR defects and 5-7 MMR alterations in cohort A;\n* 20-25 patients with germline\u002Fsomatic DDR defects and 5-7 MMR alterations in cohort B;\n* 25-35 patients with germline\u002Fsomatic DDR defects and 7-10 MMR alterations in cohort C.\n\nPatients within Cohort A will be followed up with PSA every 3 months for 3 years and early scans. They will also receive a blood sample for ctDNA\u002FCTC before (when feasible) and after radical treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression;\n\nPatients within Cohort B will be followed up with PSA and scans every 3 months. They will also receive a blood sample before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression.\n\nPatients within Cohort C will be followed up with PSA monthly and scans every 3 month. They will also receive a blood sample for ctDNA\u002FCTC before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression.","Cohort A: patients with high risk localized prostate cancer (PC) defined as \\>cT3 or PSA \\> 20 ng\u002FmL or presence of ECE or SVI at mpMRI; Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC); Cohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment.",[28,31,34],{"label":29,"type":21,"description":30,"interventionNames":21},"Cohort A:patients with high risk localized prostate cancer","Cohort A:150 patients with high risk localized prostate cancer (defined as \\>cT3 or PSA \\> 20 ng\u002FmL or presence of ECE or SVIat mpMRI), with tissue available from diagnostic biopsy\u002Fprostatectomy undergoing or who underwent curative treatment (prostatectomy\u002Fradical radiotherapy) but have not started a FU pathway.\n\nPatients within Cohort A will be followed up with PSA every 3 months for 3 years and early scans. They will also receive a blood sample for ctDNA\u002FCTC before (when feasible) and after radical treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression",{"label":32,"type":21,"description":33,"interventionNames":21},"Cohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC)","Cohort B: 100 patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) with tissue available from diagnostic biopsy of the primary and when possiblepossible, from a metastatic site. Patients must either have not started a standard treatment or have started for not longer than 3 months;Patients within Cohort B will be followed up with PSA and scans every 3 months. They will also receive a blood sample before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression",{"label":35,"type":21,"description":36,"interventionNames":21},"Cohort C:Patients with metastatic castration resistant prostate cancer (mCRPC) progressing","Cohort C:100-150 patients with metastatic castration resistant prostate cancer tissue (mCRPC) progressing on a standard treatment with available from biopsy of a metastatic site, and when possiblepossible, from the primary.Patients within Cohort C will be followed up with PSA monthly and scans every 3 month. They will also receive a blood sample for ctDNA\u002FCTC before (when feasible) or after the start of systemic treatment, 6 months and 12 months (if not progressed), at time of PSA or radiological progression.",[38,42],{"name":39,"affiliation":40,"role":41},"Pasquale Rescigno, MD","Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo","PRINCIPAL_INVESTIGATOR",{"name":43,"affiliation":40,"role":41},"Sabrina Arena, PhD",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":21,"email":49},"ilaria Buondonno, PhD","CONTACT","+390119933393","ilaria.buondonno@ircc.it",{"name":51,"role":47,"phone":52,"phoneExt":21,"email":53},"Marco Asioli","+390119933463","ufficio.trials@ircc.it",[55,75],{"facility":40,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Candiolo","Turin","10060","Italy","IT",{"type":63,"coordinates":64},"Point",[65,66],7.59812,44.95858,{"lat":66,"lon":65},[69,71,73,74],{"name":39,"role":47,"phone":21,"phoneExt":21,"email":70},"pasquale.rescigno@ircc.it",{"name":72,"role":47,"phone":48,"phoneExt":21,"email":49},"Ilaria Buondonno, PhD",{"name":39,"role":41,"phone":21,"phoneExt":21,"email":21},{"name":43,"role":41,"phone":21,"phoneExt":21,"email":21},{"facility":76,"status":56,"city":77,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"AOU San Luigi Gonzaga","Orbassano",{"type":63,"coordinates":79},[80,81],7.53813,45.00547,{"lat":81,"lon":80},[84],{"name":85,"role":47,"phone":21,"phoneExt":21,"email":21},"Francesco Porpiglia, MD",{"type":87,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100541818",false,"NCT06334809","INSIDE: Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations","Identification of Genomic Screening Pathways in Cancer Patients With DNA Repair Alterations","INSIDE","Inclusion Criteria:\n\n* Age \\> 18 years\n* Diagnosis of prostate cancer as indicated below:\n\nCohort A: patients with high risk localized prostate cancer (defined as \\>cT3 or PSA \\> 20 ng\u002FmL or presence of ECE or SVIat mpMRI), with tissue available from diagnostic biopsy\u002F prostatectomy undergoing or who underwent curative treatment (prostatectomy\u002F radical radiotherapy) but have not started a FU pathway.\n\nCohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC) with tissue available from diagnostic biopsy of the primary and when possiblepossible, from a metastatic site. Patients must either have not started a standard treatment or have started for not longer than 3 months.\n\nCohort C: patients with metastatic castration resistant prostate cancer tissue (mCRPC) progressing on a standard treatment with available from biopsy of a metastatic site, and when possiblepossible, from the primary.\n\n* Ability to understand and consent to informed consent;\n* Patient must be compliant with receiving a biopsy of the metastatic site (cohort C) and with FU assessments schedule\n\nExclusion Criteria:\n\n• Patients not willing to comply with study's procedures or fulfilling the inclusion criteria.","MALE","18 Years",{"count":98,"type":99},400,"ESTIMATED","OBSERVATIONAL","400 patients will be enrolled and divided into 3 cohorts: Cohort A: patients with high risk localized prostate cancer (PC) defined as \\>cT3 or PSA \\> 20 ng\u002FmL or presence of ECE or SVI at mpMRI;\n\nCohort B: patients with de novo metastatic hormone sensitive prostate cancer (mHSPC);\n\nCohort C: patients with metastatic castration resistant prostate cancer (mCRPC) progressing on a standard treatment.",[103],"Prostate Cancer",[105,106,107,108,109],"prostate cancer","mHSPC","castration-resistant","PARP inhibitory","mCRPC","2025-06-10",{"date":112,"type":113},"2025-06-12","ACTUAL",{"date":115,"type":113},"2023-03-09",{"date":117,"type":99},"2027-12-31",{"name":5,"class":6},2]