[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520913":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":66,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":27,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":27,"enrollmentInfo":82,"targetDuration":27,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":41,"whyStopped":27,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-fluciclovine","EXPERIMENTAL","Participants with low prostate-specific membrane antigen (PSMA) expression or neuroendocrine prostate cancer will receive:\n\n* 18F-fluciclovine PET\u002FCT within 6 weeks of standard of care exam and 68Ga-PSMA PET\u002FCT\n* 2x Blood test at time of 18F-fluciclovine PET\u002FCT and prior to treatment as determined by participants primary oncologist",[13,14],"Drug: 18F-fluciclovine","Device: PET\u002FCT",[16,22],{"type":17,"name":9,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","18F-fluciclovine is a radiotracer targeting amino-acid transporters.Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance to make images of processes that are happening in the body",[9],[21],"Axumin",{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","PET\u002FCT","Positron emission tomography\u002Fcomputed tomography (PET\u002FCT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.",[9],null,[29],{"name":30,"affiliation":31,"role":32},"Heather Jacene, MD","Dana-Farber Cancer Institute","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":27,"email":37},"CONTACT","617-632-3767","hjacene@partners.org",[39,56],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Dana Farber Cancer Institute","RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-71.05977,42.35843,{"lat":51,"lon":50},[54,55],{"name":30,"role":35,"phone":36,"phoneExt":27,"email":37},{"name":30,"role":32,"phone":27,"phoneExt":27,"email":27},{"facility":57,"status":41,"city":42,"state":43,"zip":58,"country":45,"countryCode":46,"cosmosGeoPoint":59,"geoPoint":61,"contacts":62},"Brigham and Womens Hospital","02215",{"type":48,"coordinates":60},[50,51],{"lat":51,"lon":50},[63,65],{"name":64,"role":35,"phone":36,"phoneExt":27,"email":37},"Heather A Jacene, MD",{"name":64,"role":32,"phone":27,"phoneExt":27,"email":27},{"type":32,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":31,"oldNameTitle":27,"oldOrganization":27},"Heather A. Jacene, MD","Principal Investigator",[70],{"name":71,"class":72},"Blue Earth Diagnostics","INDUSTRY","100520913","phase-1-pilot-study-for-detection-of-psma-low-crpc-ne-tumors-with-fluciclovine-petct-100520913",false,"NCT06062745","Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET\u002FCT","A Pilot Study for Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer With 18F-fluciclovine PET\u002FCT Imaging","Inclusion Criteria:\n\n* Participants must have histologically confirmed prostate cancer that is metastatic and one of the following: CRPC with PSMA-low disease defined by whole-body SUVmean ≤ 10 determined by standard-of-care 68Ga-PSMA-11 PET\u002FCT imaging with at least 5 metastatic lesions OR NEPC pathology based on tumor biopsy. This may include morphology consistent with small cell carcinoma or mixed adenocarcinoma\u002FNE features and\u002For IHC staining for NE markers. Participants should have at least 5 metastatic lesions.\n* Must have either already had standard of care 68Ga-PSMA PET\u002FCT scan or be planned for 68Ga-PSMA PET\u002FCT scan before or after the planned 18F-fluciclovine-PET\u002FCT.\n* Age ≥18 years. Since no dosing or adverse event data are currently available on the use of 18F-fluciclovine in participants \\\u003C18 years of age, and most prostate cancer occurs in the adult population, children are excluded from this study but will be eligible for future pediatric trials.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)\n* Ability and willingness to comply with the study procedures.\n* The effects of 18F-fluciclovine on the developing human fetus are unknown. For this reason and because radiopharmaceuticals may be teratogenic, men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for 24 hours after the PET\u002FCT scan is completed.\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with other known malignancy requiring treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Contraindications for PET\u002FCT including:\n\n  * Severe claustrophobia\n* Any past or current condition that in the opinion of the study investigators would confound the results of the study or pose additional risk to the patient by their participation in the study.","MALE","18 Years",{"count":83,"type":84},30,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","This research study is studying a positron emission tomography (PET) agent called 18F-fluciclovine to evaluate how well 18F-fluciclovine-PET scans determine the extent of advanced prostate cancer that either has low prostate-specific membrane antigen (PSMA) expression or has neuroendocrine features.\n\nThe name of the study interventions are:\n\n* 18F-fluciclovine-PET\u002FCT scan\n* Two research blood collections",[90,91,92],"Advanced Prostate Cancer","Metastatic Prostate Cancer","Metastatic Prostate Neuroendocrine Carcinoma",[90,91,92,94],"PSMA-Low Castration Resistant Prostate Cancer","2025-11-04",{"date":97,"type":98},"2025-11-05","ACTUAL",{"date":100,"type":98},"2024-02-01",{"date":102,"type":84},"2028-09-01",{"name":5,"class":6},2]