[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05242744":3,"trial-entities:NCT05242744":99,"trial-summary:NCT05242744":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":58,"minimum_age":59,"maximum_age":24,"healthy_volunteers":24,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":87,"overall_officials":94,"references":97,"see_also_links":98},"NCT05242744","UPCC 08821","FTT PET\u002FCT in Metastatic Prostate Cancer","Evaluating in Vivo PARP-1 Expression With 18F-FluorThanatrace Positron Emission Tomography (PET\u002FCT) in Patients With Metastatic Prostate Cancer","RECRUITING","2027-07","2026-06","2026-06-26","2023-03-01","Abramson Cancer Center at Penn Medicine","OTHER",true,"Up to 30 men with metastatic prostate cancer will undergo up to 2 FTT PET\u002FCT scans to look at PARP activity in sites of known cancer. Subjects will undergo a baseline scan prior to starting new therapy and a second, optional, post-therapy scan 1-21 days after the start of treatment. Tissue from a clinical or research biopsy will be compared to imaging measures, if available.","Up to 30 evaluable patients with a histological diagnosis of prostate cancer with clinical evidence of metastatic disease who are being considered for new therapy or for a change in therapy with a PARP inhibitor, androgen deprivation therapy, and\u002For chemotherapy as part of their clinical care will be enrolled in this study. A pre-treatment 18F-FluorThanatrace (\\[18F\\]FTT) positron emission tomography\u002F computed tomography (PET\u002FCT) scan will be done prior to the start of a new therapy regimen. PET\u002FCT imaging will be used to evaluate PARP-1 expression in sites of prostate cancer using the investigational radiotracer \\[18F\\]FTT. This is an observational study in that \\[18F\\]FTT PET\u002FCT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the \\[18F\\]FTT PET\u002FCT results, treatment decisions will be made by the treating physicians based upon clinical criteria. After injection of \\[18F\\]FTT patients will undergo a skull base to mid-thigh scan, starting at approximately 60 minutes post injection. PET\u002FCT imaging sessions will include an injection of 12 mCi of \\[18F\\]FTT intravenously (approximate range for most studies is anticipated to be 8-12 mCi ). of \\[18F\\] FTT. Data will be collected to evaluate uptake of \\[18F\\]FTT in sites of prostate cancer, which will be compared with PARP-1 expression in tissue, when available. All evaluable patients may start new therapy following the \\[18F\\]FTT PET\u002FCT scan. It is expected that due to patient preference and time considerations, approximately 80% will also undergo a second (optional) scan that will be performed approximately 1-21 days after new therapy has started. The second scan is obtained to evaluate whether the initiation of a PARP inhibitor and\u002For androgen deprivation therapy and\u002For chemotherapy alters \\[18F\\] FTT uptake.",[19],"Prostate Cancer Metastatic",[21,22],"PET\u002FCT","PARP inhibitor","OBSERVATIONAL",null,[],{"count":27,"type":28},30,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"DRUG","[18F]FluorThanatrace","Investigational radiopharmaceutical used with Positron Emission Tomography (PET\u002FCT) imaging that may provide a non-invasive measurement of PARP-1 expression",[35],"Metastatic prostate cancer",[37],"[18F]FTT",[39],{"measure":40,"description":41,"timeFrame":42},"Measurement of effect size","To establish effect size of change in FTT uptake before and after systemic therapy in men with prostate cancer metastasis using \\[18F\\]FluorThanatrace (\\[18F\\]FTT)","21 days",[44,47,51,54],{"measure":45,"description":46,"timeFrame":42},"Evaluation of PARP expression","Evaluation of PARP-1 expression in prostate cancer using measures of uptake of \\[18F\\]FTT before and after PARPi and\u002For androgen deprivation therapy and\u002For chemotherapy",{"measure":48,"description":49,"timeFrame":50},"Correlation with PARP-1 IHC","Correlation of \\[18F\\]FTT uptake measures with PARP-1 IHC expression in the tissue specimen, when available","6 months",{"measure":52,"description":53,"timeFrame":50},"Correlation with PARP-1 autoradiography","Correlation of \\[18F\\]FTT uptake measures with PARP-1 \\[125I\\]KX1 autoradiography expression in the tissue specimen, when available",{"measure":55,"description":56,"timeFrame":57},"Predication of clinical response","Determination of whether baseline and\u002For pre-\u002Fpost-treatment changes in \\[18F\\]FTT uptake predict clinical response as measured by progression-free survival (PFS) and anatomic criteria on standard of care imaging","1 year","MALE","18 Years",{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"Inclusion Criteria:\n\n1. Participants will be ≥ 18 years of age\n2. Histologically proven prostate carcinoma\n3. Clinical evidence of metastatic disease with at least one lesion identified on standard of care imaging (CT, MRI, Bone Scan, FDG or other PET\u002FCT, Ultrasound)\n4. Considered a candidate for new therapy or change in therapy with PARP inhibitor therapy and\u002For androgen deprivation therapy (ADT) and\u002For chemotherapy with or without additional agents, either on a clinical trial or as part of clinical care.\n5. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":69,"status":8,"city":70,"state":71,"zip":72,"country":73,"contacts":74,"geoPoint":84},"University of Pennsylvania Hospital","Philadelphia","Pennsylvania","19104","United States",[75,81],{"name":76,"role":77,"phone":78,"phoneExt":79,"email":80},"Erin Schubert","CONTACT","215-573-6569","2155736569","erin.schubert@pennmedicine.upenn.edu",{"name":82,"role":83},"Neil Taunk, MD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},39.95238,-75.16362,[88,90],{"name":89,"role":77,"phone":78,"email":80},"Erin Schubert, BA",{"name":91,"role":77,"phone":92,"email":93},"Ashley Veronsky, BA","215-898-4346","ashley.veronsky@pennmedicine.upenn.edu",[95],{"name":82,"affiliation":96,"role":83},"University of Pennsylvania",[],[],{"nct_id":4,"conditions":100,"biomarkers":102},[101],"Prostate Carcinoma",[],{"nct_id":4,"found":15,"summary":104,"prompt_version":114},{"design":105,"status":106,"heading":107,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an observational study involving up to 30 men. It is not specified if it is blinded or what phase it is in.","completed","Observational Study of FTT PET\u002FCT in Metastatic Prostate Cancer","This observational study is looking at men with metastatic prostate cancer to see how a special imaging scan, called FTT PET\u002FCT, can measure PARP activity in their cancer. PARP is a protein that helps repair damaged DNA in cancer cells. You would receive an investigational radiopharmaceutical called [18F]FluorThanatrace, which helps the FTT PET\u002FCT scan show PARP activity. Up to 30 men will have at least one FTT PET\u002FCT scan before starting a new treatment, and some may have a second scan after starting treatment. The study aims to see how well the FTT PET\u002FCT scan measures PARP activity in the cancer. The current status of this study is unclear.","The primary endpoint measurement is taken at 21 days after starting treatment.",109,"You would undergo up to two FTT PET\u002FCT scans. The first scan is before starting new therapy, and the second, optional, scan is 1-21 days after starting treatment.","Not stated in the trial record.",[32],"v2"]