[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416259":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":23,"studyPopulation":16,"armGroups":24,"interventions":35,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":71,"collaborators":16,"id":74,"slug":16,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":16,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":16,"enrollmentInfo":82,"targetDuration":16,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":16,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Hoag Memorial Hospital Presbyterian","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Detection of unsuspected metastases in high risk prostate cancer","Determine the rate of detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or radiation therapy.","up to 4 weeks",{"measure":14,"description":15,"timeFrame":12},"Detection of unsuspected metastases in biochemically recurrent prostate cancer","Determine the rate of detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, yet no evidence of disease on CT\u002Fbone scan.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"NON_RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":22,"maskingDescription":16,"whoMasked":16},"NONE","This will be a phase II clinical trial to assess the clinical value of PyL for detection of disease in pateints with:\n\n1. High risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and\n2. Biochemically recurrent prostate cancer (arm 2) but without evidence of disease of standard of care imaging (CT of the chest\u002Fabdomen\u002Fpelvis and bone scan).\n\nIn both cohorts, PyL PET\u002FCT will be obtained and evaluated by a nuclear radiologist trained in novel PET radiotracers, including PyL. Lesions suspicious for disease of PyL that were unsuspected on standard of care imaging will be selected for biopsy for pathologic confirmation if feasible . Pathology will be used as the reference standard for confirming malignancy.",[25,31],{"label":26,"type":27,"description":28,"interventionNames":29},"High risk prostate cancer","EXPERIMENTAL","DCFPyL PET\u002FCT will be compared to CT\u002Fbone scan for detection of unsuspected metastases in patients with high risk prostate cancer and planned prostatectomy or or radiation therapy",[30],"Drug: DCFPyL PET\u002FCT",{"label":32,"type":27,"description":33,"interventionNames":34},"Biochemically recurrent prostate cancer","DCFPyL PET\u002FCT will be utilized for detection of unsuspected metastases in patients with biochemically recurrent prostate cancer, but with no evidence of disease on CT\u002Fbone scan.",[30],[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":16},"DRUG","DCFPyL PET\u002FCT","Prostate Membrane Specific Antigen-specific imaging",[32,26],[42],{"name":43,"affiliation":5,"role":44},"Deborah Fridman, PsyD, RN","STUDY_DIRECTOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":16,"email":50},"Beth Thomsen","CONTACT","949-764-4577","clinicalresearch@hoag.org",[52],{"facility":5,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"RECRUITING","Irvine","California","92618","United States","US",{"type":60,"coordinates":61},"Point",[62,63],-117.82311,33.66946,{"lat":63,"lon":62},[66,68],{"name":47,"role":48,"phone":16,"phoneExt":16,"email":67},"beth.thomsen@hoag.org",{"name":69,"role":70,"phone":16,"phoneExt":16,"email":16},"Gary Ulaner, MD","PRINCIPAL_INVESTIGATOR",{"type":70,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Gary Ulaner","Director Molecular Imaging and Therapy","100416259",false,"NCT04700332","PyL in Patients With High Risk and Biochemically Recurrent Prostate Cancer","2-(3-{1-carboxy-5-[(6-18F-fluoro-pyridine-3-carbonyl)-Amino]-Pentyl}-Ureido)-Pentanedioic Acid (PyL) in Patients With High Risk and Biochemically Recurrent Prostate Cancer","Inclusion Criteria:\n\n1. Male ≥ 18 years of age.\n2. Histologically confirmed adenocarcinoma of the prostate\n3. Patients meet one of the follow criteria:\n\nCohort 1: High risk prostate cancer (PSA \\>10, Gleason 8-10, or clinical stage \\>T2c) and planned prostatectomy or radiation therapy or Cohort 2: Biochemical prostate cancer relapse (Prostate Specific Antigen (PSA) \\> 0.2 ng\u002Fml in patients following prostatectomy or ≥ 2 ng\u002Fml more than the PSA nadir in patient following radiotherapy, as defined by the ASTRO-Phoenix criteria \\[18\\] and no evidence of malignancy on standard of care imaging for metastases (CT of the chest\u002Fabdomen\u002Fpelvis and bone scan) within 3 months.\n\nExclusion Criteria:\n\n1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n2. Patients who cannot undergo PET\u002FCT scanning because of weight limits. PET\u002FCT scanners may not be able to function with patients over 450 pounds.\n3. Change in therapy since standard of care imaging","MALE","18 Years",{"count":83,"type":84},184,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","The standard of care imaging of prostate cancer metastases recommended by the National Comprehensive Cancer Network (NCCN), CT of the chest\u002Fabdomen\u002Fpelvis and bone scan, may be suboptimal. PyL is a novel PET tracer designed to detect prostate specific membrane antigen (PSMA) expressed on prostate cancer cells. PyL PET\u002FCT may provide improved evaluation of clinically significant metastases in patients with prostate cancer.",[90],"Prostate Cancer",[90,38,92,93],"Staging","Biochemical relapse","2021-07-26",{"date":96,"type":97},"2021-07-27","ACTUAL",{"date":99,"type":97},"2021-02-01",{"date":101,"type":84},"2022-12-15",{"name":5,"class":6},1]