[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659245":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":25,"interventions":41,"overallOfficials":17,"centralContacts":51,"locations":17,"responsibleParty":59,"collaborators":17,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":17,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":17,"enrollmentInfo":70,"targetDuration":17,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":116,"whyStopped":17,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":17},{"fullName":5,"class":6},"RayzeBio, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of AEs, SAEs, and Adverse Events of Special Interest (AESIs)","Incidence of AEs, SAEs, and AESIs including changes in vital signs, clinical laboratory evaluations, 12-lead ECG, and other safety findings","From informed consent up to 3 months post-RYZ711 PET\u002FCT",{"measure":14,"description":15,"timeFrame":16},"Concordance Rate of RYZ711 PET\u002FCT Compared with PSMA PET\u002FCT","The concordance rate is defined as the proportion of subjects with per-region correspondence of at least 1 lesion identified on RYZ711 PET\u002FCT and PSMA PET\u002FCT","Up to 3 months post-RYZ711 PET\u002FCT",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"NON_RANDOMIZED","PARALLEL","This study aims to determine the safety, tolerability, and diagnostic performance of RYZ711 PET\u002FCT in men with histologically confirmed adenocarcinoma of the prostate across 3 cohorts: subjects with newly diagnosed unfavorable intermediate-, high-, or very high-risk prostate cancer planned for Radical Prostatectomy (RP) with extended Pelvic Lymph Node Dissection (PLND) (Cohort 1), subjects with suspected biochemical recurrence (BCR) of prostate cancer following definitive therapy (Cohort 2), and subjects with metastatic disease (mHSPC or mCRPC) who may be candidates for PSMA-targeted radiopharmaceutical therapy (Cohort 3).","DIAGNOSTIC",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE",[26,33,37],{"label":27,"type":28,"description":29,"interventionNames":30},"Cohort 1 - RYZ711","EXPERIMENTAL","High-risk localized prostate cancer planned for RP\u002FPLND",[31,32],"Drug: RYZ711","Diagnostic Test: PSMA PET\u002FCT",{"label":34,"type":28,"description":35,"interventionNames":36},"Cohort 2 - RYZ711","Biochemical recurrence after definitive therapy",[31,32],{"label":38,"type":28,"description":39,"interventionNames":40},"Cohort 3 - RYZ711","Metastatic disease (mHSPC or mCRPC)",[31,32],[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":17},"DRUG","RYZ711","RYZ711 PET\u002FCT; PSMA PET\u002FCT",[27,34,38],{"type":48,"name":49,"description":45,"armGroupLabels":50,"otherNames":17},"DIAGNOSTIC_TEST","PSMA PET\u002FCT",[27,34,38],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":17,"email":56},"RayzeBio Clinical Trials","CONTACT","+1 619 657 0057","clinicaltrials@rayzebio.com",{"name":58,"role":54,"phone":17,"phoneExt":17,"email":17},"Anthony A Golsorkhi, MD, Study Director, RayzeBio, Inc, MD Study Director",{"type":60,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100659245","phase-1-ryz711-diagnostic-platform-study-100659245",false,"NCT07862582","RYZ711 Diagnostic Platform Study","Phase 1 \u002F2 Multicenter, Basket, Imaging Study Investigating the Safety and Diagnostic Performance of RYZ711 in Men With Prostate Cancer.","Inclusion Criteria\n\nSubjects who meet all of the following criteria are eligible for inclusion in the study:\n\n1. Histologically confirmed adenocarcinoma of the prostate\n2. ECOG PS ≤ 2\n3. Planned or scheduled PSMA PET\u002FCT scan\n4. Cohort 1: Unfavorable intermediate-risk or higher per NCCN 2026 guidelines, with planned RP and extended PLND within 6 weeks of RYZ711 PET\u002FCT\n5. Cohort 2: Rising PSA after definitive therapy meeting standard BCR criteria (AUA 2026 or Phoenix criteria)\n6. Cohort 3: mHSPC or mCRPC with documented disease progression; candidate for PSMA-targeted radiopharmaceutical therapy\n\nExclusion Criteria\n\nSubjects who meet any of the following criteria will be excluded from the study:\n\n1. eGFR \\\u003C 60 mL\u002Fmin, QTcF \\> 470 ms, impaired hepatic function\n2. Neuroendocrine, sarcomatoid, or spindle cell prostate cancer\n3. Non-prostate metastatic malignancy\n4. Cohort 1: Any prior prostate cancer therapy\n5. Cohort 2: Ongoing or recent ADT (within 3 months prior to Day 1)\n6. Cohort 3: Prior ¹⁷⁷Lu-PSMA therapy within 6 weeks of PSMA PET\u002FCT","MALE","18 Years",{"count":71,"type":72},116,"ESTIMATED","INTERVENTIONAL",[75,76],"PHASE1","PHASE2","This is a Phase 1\u002F2 multicenter, multi-cohort imaging study to evaluate the safety, tolerability, and diagnostic performance of RYZ711 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) in men with histologically confirmed adenocarcinoma of the prostate.",[79,80,81,82,83,84],"Prostate Cancer (Adenocarcinoma)","Adenocarcinoma of the Prostate","Metastatic Castration-resistant Prostate Cancer (mCRPC)","Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)","Biochemical Recurrence (BCR)","High-Risk Localized Prostate Cancer",[86,80,87,88,89,44,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"Prostate Cancer","ACP3","Acid Phosphatase 3","PAP","PET\u002FCT","Positron Emission Tomography","Diagnostic Imaging","Radiopharmaceutical","Radiotracer","PSMA","Prostate-Specific Membrane Antigen","Biochemical Recurrence","Radical Prostatectomy","Pelvic Lymph Node Dissection","PLND","mCRPC","mHSPC","Metastatic Castration-Resistant Prostate Cancer","Metastatic Hormone-Sensitive Prostate Cancer","Targeted Imaging","Prostate-Specific Antigen","PSA","Concordance Rate","Diagnostic Performance","Phase 1","Phase 2","Basket Study","Multicenter Study","Gallium-68 \u002F ⁶⁸Ga","68Ga-PSMA-11","NOT_YET_RECRUITING","2026-10-01",{"date":119,"type":120},"2026-10-07","ACTUAL",{"date":122,"type":72},"2026-10",{"date":124,"type":72},"2027-12",{"name":5,"class":6}]