[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07222436":3,"trial-entities:NCT07222436":86,"trial-summary:NCT07222436":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":46,"minimum_age":47,"maximum_age":23,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":57,"locations":60,"central_contacts":79,"overall_officials":81,"references":84,"see_also_links":85},"NCT07222436","HCC 25-054","Circulating Tumor DNA in High Risk Localized Prostate Cancer","RECRUITING","2027-09-30","2025-10","2025-10-29","2025-09-23","University of Pittsburgh","OTHER",true,"This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.","The Vogelstein lab has developed a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors. Plasma will be assayed for ctDNA using the SaferSeqS tumor-informed assay, employing DNA sequences derived from prostatectomy specimens. The abundance and molecular characteristics of ctDNA will be evaluated for a pilot group of 12-24 patients using an adaptive statistical design.",[18],"Prostate Cancer",[20,21],"prostatectomy","ctDNA","OBSERVATIONAL",null,[],{"count":26,"type":27},24,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"ctDNA detection","Detection of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.","Up to 2 years",[35,38,42,44],{"measure":36,"description":37,"timeFrame":33},"ctDNA abundance","Quantification of ctDNA by assay in blood collected prior to radical prostatectomy using the Vogelstein lab assay. This assay is a highly sensitive, tumor-informed method of detecting circulating free DNA (cfDNA) shed by solid tumors that has shown prognostic value for recurrence and predictive for benefit of adjuvant chemotherapy.",{"measure":39,"description":40,"timeFrame":41},"serum PSA recurrence","The detection of prostate-specific antigen (PSA) levels that rise after initial treatment for prostate cancer. This can indicate a regrowth of cancer cells or a biochemical recurrence, meaning that while the cancer may not be visible on imaging, it is still present in the body.","At 6 weeks post-operative",{"measure":39,"description":40,"timeFrame":43},"At 6 months post-operative",{"measure":39,"description":40,"timeFrame":45},"At 12 months post-operative","MALE","18 Years",false,{"inclusion":50,"exclusion":55,"raw_text":56},[51,52,53,54],"Localized prostate adenocarcinoma on active surveillance","Biochemically-recurrent prostate adenocarcinoma after definitive local therapy","Hormone-sensitive, metastatic prostate adenocarcinoma","Metastatic CRPC",[],"Inclusion Criteria:\n\n1. Must have histologically confirmed prostate cancer.\n2. Age ≥ 18 years.\n3. ECOG performance status of 0-1.\n4. Must have the ability to understand and the willingness to sign a written informed consent document.\n5. Willing to provide serial blood samples for the study.\n6. Willing to provide tumor tissue (prostatectomy for primary cohort; prostatectomy or biopsy for exploratory cohort) for correlative studies which will compare ctDNA to tumor specimens.\n7. Primary Cohort: High-risk localized prostate adenocarcinoma defined as one or more of the following:\n\n   o Clinical stage ≥ cT3a, Grade Group 4 or 5 (Gleason sum 8-10), and PSA ≥ 20\n\n   \\*Non-bulky pelvic lymphadenopathy and indeterminate findings on staging imaging (CT, bone scan, PSMA PET CT) are allowed if the surgeon believes RP is appropriate.\n8. Exploratory Cohort: Men with a diagnosis of prostate adenocarcinoma and one of the following:\n\n   * Localized prostate adenocarcinoma on active surveillance\n   * Biochemically-recurrent prostate adenocarcinoma after definitive local therapy\n   * Hormone-sensitive, metastatic prostate adenocarcinoma\n   * Metastatic CRPC\n\nExclusion Criteria:\n\n1. History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.\n2. Receiving androgen deprivation or other systemic therapy for prostate cancer.\n3. Medical condition or social situation that may preclude adherence to the protocol.\n\n   \\-",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":76},"UPMC Hillman Cancer Center","Pittsburgh","Pennsylvania","15232","United States",[68,73],{"name":69,"role":70,"phone":71,"email":72},"Brieanna Marino, MS","CONTACT","4126478258","rowlesbm@upmc.edu",{"name":74,"role":75},"Leonard J Appleman, MD","PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},40.44062,-79.99589,[80],{"name":69,"role":70,"phone":71,"email":72},[82],{"name":83,"affiliation":62,"role":75},"Leonard J Appleman, MD, PhD",[],[],{"nct_id":4,"conditions":87,"biomarkers":89},[88],"Prostate Carcinoma",[],{"nct_id":4,"found":14,"summary":91,"prompt_version":101},{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study, meaning participants will not receive an experimental treatment. It plans to enroll 24 participants.","completed","Circulating Tumor DNA in High-Risk Localized Prostate Cancer","This study is looking at a new way to detect prostate cancer cells in the blood of men with high-risk localized prostate cancer. Researchers will collect blood samples before surgery (prostatectomy) to see if they can find circulating tumor DNA (ctDNA). This ctDNA is genetic material shed by cancer cells into the bloodstream. The study aims to see how well this method works to find ctDNA over a period of up to two years. You might be able to join if you are a man aged 18 or older with confirmed prostate cancer, have a good performance status (meaning you can perform daily activities), and are willing to provide blood samples. The study is currently unclear on its recruitment status and plans to enroll 24 participants.","The primary endpoint, ctDNA detection, will be measured for up to 2 years.",126,"You would need to provide serial blood samples for the study.","Not stated in the trial record.",[],"v2"]