[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636663":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":48,"overallOfficials":32,"centralContacts":61,"locations":67,"responsibleParty":85,"collaborators":32,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":32,"enrollmentInfo":97,"targetDuration":32,"studyType":100,"phases":101,"briefSummary":102,"conditions":103,"keywords":32,"overallStatus":70,"whyStopped":32,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"German Oncology Center, Cyprus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":32},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Sensitivity","Sensitivity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true positives to the total number of segments with the disease (true positives + false negatives).","24 months",{"measure":14,"description":15,"timeFrame":12},"Absolute GTV volumes","Conventional mpMRI, MRI-RSI and PSMA-PET derived absolute GTV volumes in ml",{"measure":17,"description":18,"timeFrame":12},"Specificity","Specificity for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities will be calculated on a prostate segment (n=6) level. The prostate cancer distribution in targeted biopsy cores will serve as the ground truth, calculated with the ratio of true negatives to the total number of segments without the disease (true negatives + false positives).",{"measure":20,"description":21,"timeFrame":12},"ROC-AUC","ROC-AUC for PSMA PET, conventional mpMRI, MRI-RSI and combined modalities on a segment level in comparison with prostate cancer distribution in targeted biopsy cores on a 6 segment level (ground truth). It will be calculated by integrating the area under the TPR (Sensitivity) vs FPR (1-Specificity) curve",[23,26,29],{"measure":24,"description":25,"timeFrame":12},"Dice Sorensen Coefficient (DSC)","The DSC is defined as followed: twice the size of the intersection of two sets, divided by the sum of the sizes of the two sets. The DSC will be used to compare different GTVs and likewise analyse the geometric overlap and the interobserver variance.",{"measure":27,"description":28,"timeFrame":12},"Dose volume histogram parameters in volume (ml) in relation to Gray","Comparison of planning parameters and DVH metrics after PSMA PET and\u002For MRI-RSI based radiotherapy for target volumes and organs at risk.",{"measure":30,"description":31,"timeFrame":12},"Correlation coefficient (Spearman or Pearson)","Quantitative imaging parameters from PSMA-PET, MRI-RSI and mpMRI images will be extracted and cross correlated with the ArteraAI MMAI test score (if available), Prolaris, the Ki-67 staining, the ISUP grade, serum PSA levels and the cTstage",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40],{"label":41,"type":42,"description":43,"interventionNames":44},"Prospective comparison of PSMA PET\u002FCT and MRI-RSI for patients with primary prostate cancer","EXPERIMENTAL","MRI-RSI imaging of the prostate (non-invasive)",[45,46,47],"Diagnostic Test: MRI","Diagnostic Test: 18F-PSMA1007 PET-CT","Diagnostic Test: MR-guided TRUS Prostate biopsy",[49,53,57],{"type":50,"name":51,"description":43,"armGroupLabels":52,"otherNames":32},"DIAGNOSTIC_TEST","MRI",[41],{"type":50,"name":54,"description":55,"armGroupLabels":56,"otherNames":32},"18F-PSMA1007 PET-CT","PET scan according to standard protocol",[41],{"type":50,"name":58,"description":59,"armGroupLabels":60,"otherNames":32},"MR-guided TRUS Prostate biopsy","Biopsy according to standard protocol",[41],[62],{"name":63,"role":64,"phone":65,"phoneExt":32,"email":66},"CONSTANTINOS ZAMBOGLOU, DR","CONTACT","+35725208000","kristis.vevis@goc.com.cy",[68],{"facility":69,"status":70,"city":71,"state":32,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"German Oncology Center","RECRUITING","Limassol","4108","Cyprus","CY",{"type":76,"coordinates":77},"Point",[78,79],33.03794,34.68406,{"lat":79,"lon":78},[82],{"name":83,"role":64,"phone":65,"phoneExt":32,"email":84},"CONSTANTINA CLOCONI","constantina.cloconi@goc.com.cy",{"type":86,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100636663","comparing-psma-petct-and-mri-rsi-for-finding-and-outlining-tumors-inside-the-prostate-in-men-with-newly-diagnosed-prostate-cancer-100636663",false,"NCT07568613","Comparing PSMA PET\u002FCT and MRI-RSI for Finding and Outlining Tumors Inside the Prostate in Men With Newly Diagnosed Prostate Cancer","Prospective Comparison of PSMA PET\u002FCT and MRI-RSI (Restriction Spectrum Imaging) for Intraprostatic Tumor Detection and Delineation in Primary Prostate Cancer Patients","PRIDE2-PC","Inclusion Criteria:\n\n* Newly diagnosed and histologically confirmed primary prostate cancer\n* NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk\n* Males, age ≥ 18 years\n* ECOG performance status 0-2\n* Estimated life expectancy ≥ 5 years\n* PSMA-PET\u002FCT-hybrid imaging performed \\\u003C3 months\n* MRI-targeted biopsy on PIRADs v2.1 lesion ≥3 performed \\\u003C6 months\n\nExclusion Criteria:\n\n* Contraindications for MRI imaging\n* No visible tumor on PSMA PET and mpMRI (defined by PIRADs v2.1 ≤2 lesion)\n* TUR-P of the prostate \\\u003C1 year ago\n* Initial PSA \\>100 ng\u002Fml\n* History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease)\n* Previous radiation therapy to the pelvis\n* ADT or ADT + other systemic therapy before inclusion","MALE","18 Years",{"count":98,"type":99},50,"ESTIMATED","INTERVENTIONAL",[34],"The detection and delineation of the intraprostatic tumor burden plays a crucial role in the personalized treatment of primary prostate cancer. The current gold standard multiparametric magnetic resonance imaging (mpMRI) is used to guide targeted prostate biopsies for initial diagnostic work up and for definitive focal dose-escalated radiotherapy in intermediate and high-risk prostate cancer patients.\n\nHowever, mpMRI might underestimate the tumor volume and manual gross tumor volume delineation based on mpMRI underlies significant interobserver variability. Thus, novel imaging modalities are warranted to increase the detection rate and\u002For decrease the interobserver variability during tumor delineation.\n\nThis study will prospectively compare two promising advanced medical imaging methods: MRI-RSI and PSMA PET with the current gold-standard mpMRI for tumor detection and delineation in primary prostate cancer patients.",[104],"Prostate Cancer","2026-04-28",{"date":107,"type":108},"2026-05-06","ACTUAL",{"date":110,"type":108},"2025-08-18",{"date":112,"type":99},"2027-07-31",{"name":5,"class":6},1]