[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504723":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":92,"centralContacts":96,"locations":107,"responsibleParty":126,"collaborators":129,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":101,"eligibilityCriteria":139,"healthyVolunteers":140,"sex":141,"minAge":142,"maxAge":101,"enrollmentInfo":143,"targetDuration":101,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":101,"overallStatus":109,"whyStopped":101,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Northwestern University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (rhPSMA, PET-MRI, mpMRI)","EXPERIMENTAL","Patients receive rhPSMA-7.3 IV then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.",[13,14,15,16,17,18,19],"Procedure: Biopsy of Prostate","Genetic: Decipher Prostate Cancer Test","Other: Flotufolastat F-18 Gallium","Procedure: Magnetic Resonance Imaging","Procedure: Multiparametric Magnetic Resonance Imaging","Procedure: Positron Emission Tomography","Procedure: Radical Prostatectomy",[21,29,38,51,66,75,86],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Biopsy of Prostate","Undergo MRI\u002FPET prostate biopsy",[9],[27,28],"Prostate Biopsy","Prostatic Biopsy",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"GENETIC","Decipher Prostate Cancer Test","Undergo decipher",[9],[35,36,37],"Decipher","Decipher Metastasis Test","Decipher Test",{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Flotufolastat F-18 Gallium","Given IV",[9],[43,44,45,46,47,48,49,50],"(18F)-rhPSMA-7.3","18F-rhPSMA-7.3","18FrhPSMA-7.3","F-18-rhPSMA-7.3","Fluorine F 18 radiohybrid PSMA-7.3","Fluorine F 18 rhPSMA-7.3","Fluorine-18 rhPSMA-7.3","rhPSMA-7.3 (18F)",{"type":22,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"Magnetic Resonance Imaging","Undergo PET-MRI",[9],[56,57,58,59,60,61,62,63,64,65],"Magnetic Resonance","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging",{"type":22,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Multiparametric Magnetic Resonance Imaging","Undergo mpMRI",[9],[71,72,73,74],"MP-MRI","mpMRI","Multi-parametric MRI","Multiparametric MRI",{"type":22,"name":76,"description":53,"armGroupLabels":77,"otherNames":78},"Positron Emission Tomography",[9],[79,80,81,82,83,84,85],"Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron Emission Tomography Scan","Positron-Emission Tomography","proton magnetic resonance spectroscopic imaging","PT",{"type":22,"name":87,"description":88,"armGroupLabels":89,"otherNames":90},"Radical Prostatectomy","Undergo radical prostatectomy",[9],[91],"Prostatovesiculectomy",[93],{"name":94,"affiliation":5,"role":95},"Ashley E Ross","PRINCIPAL_INVESTIGATOR",[97,103],{"name":98,"role":99,"phone":100,"phoneExt":101,"email":102},"Sophia Kallas","CONTACT","312-694-9001",null,"sophia.kallas@northwestern.edu",{"name":104,"role":99,"phone":105,"phoneExt":101,"email":106},"Nikki Hubbard","3126-694-9001","nikki.hubbard@northwestern.edu",[108],{"facility":5,"status":109,"city":110,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":120,"contacts":121},"RECRUITING","Chicago","Illinois","60611","United States","US",{"type":116,"coordinates":117},"Point",[118,119],-87.65005,41.85003,{"lat":119,"lon":118},[122,125],{"name":123,"role":99,"phone":100,"phoneExt":101,"email":124},"Ashley E. Ross","Ashley.ross@nm.org",{"name":123,"role":95,"phone":101,"phoneExt":101,"email":101},{"type":95,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":101,"oldOrganization":101},"Ashley Ross MD, PhD","Associate Professor, Department of Urology",[130],{"name":131,"class":132},"National Cancer Institute (NCI)","NIH","100504723","early-phase-1-rhpsma-73-pet-mri-imaging-for-the-detection-of-prostate-cancer-among-men-who-are-otherwise-candidates-for-active-surveillance-100504723",false,"NCT05852041","rhPSMA-73 PET-MRI Imaging for the Detection of Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance","A Pilot Study of rhPSMA-PET MRI Imaging for the Detection of Clinically Actionable Prostate Cancer Among Men Who Are Otherwise Candidates for Active Surveillance","Inclusion Criteria:\n\n* Healthy men (Eastern Cooperative Oncology Group \\[ECOG\\] 0-1), \\>= 18 years old with at least 10 year life expectancy\n* Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate\n* Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \\>= 10 core biopsy and informed by prior mpMRI\n* Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen \\[PSA\\] \\\u003C 10ng\u002Fml, Gleason Grade Group 1 \\[Gleason 3+3=6\\] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng\u002Fml, Gleason Grade Group 2 \\[Gleason score 3+4=7\\])\n* Decipher genomic classifier score from prior biopsy \\>= 0.45\n* Institutional Review Board (IRB)-\u002FIndependent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures\n* Concurrent diseases and malignancies are permitted\n* Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study\n* Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging\n\nExclusion Criteria:\n\n* Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer\n* NCCN very low risk category (T1c and Gleason Grade Group 1 \\[Gleason score 3+3=6\\], PSA \\\u003C 10 ng\u002FmL, fewer than 3 prostate biopsy cores positive, =\\\u003C 50% cancer in any core, PSA density \\\u003C 0.15 ng\u002FmL\u002Fg)\n* Decipher score \\\u003C 0.45\n* Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate \\[HoLEP\\], transurethral resection of the prostate \\[TURP\\], Urolift, Rezum)\n* Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening\n* Contra-indication or relative contra-indication to MRI (i.e., pacemaker)\n* History of hip replacement\n* Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening",true,"MALE","18 Years",{"count":144,"type":145},40,"ESTIMATED","INTERVENTIONAL",[148],"EARLY_PHASE1","This clinical trial evaluates whether positron emission tomography-magnetic resonance imaging (PET-MRI) using the radioactive drug radiohybrid prostate-specific membrane antigen (rhPSMA)-7.3 may help in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer who are candidates for active surveillance. A PET scan is a test that uses a radioactive drug and a computer to create images of how organs and tissues in the body are functioning. The radioactive drug used in this study, rhPSMA-7.3, attaches to the abnormal cells in the body at a different rate than normal cells which allows the scanner to create a detailed picture of how the body is working. An MRI scan uses strong magnets and computers to create detailed images of the soft tissue in your body. A multiparametric (mp)MRI is a type of MRI scan that creates a more detailed picture of the prostate gland. Using rhPSMA-73 with PET-MRI and mpMRI may be more effective in detecting higher grade or stage disease in men with low and favorable intermediate risk prostate cancer.",[151,152,153,154],"Prostate Adenocarcinoma","Stage I Prostate Cancer AJCC v8","Stage IIA Prostate Cancer AJCC v8","Stage IIB Prostate Cancer AJCC v8","2026-06-30",{"date":157,"type":158},"2026-07-02","ACTUAL",{"date":160,"type":158},"2023-06-07",{"date":162,"type":145},"2035-06-07",{"name":5,"class":6},1]