[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05011383":3,"trial-entities:NCT05011383":312,"trial-summary:NCT05011383":319},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":49,"eligibility_criteria":50,"std_ages":76,"locations":79,"central_contacts":302,"overall_officials":308,"references":310,"see_also_links":311},"NCT05011383","SPLP-003-20F","High Dose Testosterone for ATM, CDK12 or CHEK2 Altered Prostate Cancers","High-dose Testosterone in Men With Metastatic Castration-resistant Prostate Cancer and ATM or CDK12 Deficiency","RECRUITING","2027-08-31","2026-07","2026-07-23","2021-08-31","VA Office of Research and Development","FED",true,"This study will determine whether the presence of DNA repair deficiency in the form of alterations in the genes ATM, CDK12 or CHEK2 predicts for a high likelihood of responding to the use of intermittent high dose testosterone. This therapy may result in responses in tumors which are genetically unstable because of DNA repair deficiency and this is a prospective study to test that hypothesis","This is an unblinded, three cohort phase II study evaluating the efficacy of high dose testosterone (BAT) for patients with mCRPC and inactivating mutations in ATM, CDK12 or CHEK2. Patients will receive BAT until disease progression or intolerance, whichever occurs first. Throughout the study, safety and tolerability will be assessed by frequent recording of adverse events, vital signs and safety laboratory assessments. Progression will be evaluated with bone scan, CT of the abdomen\u002Fpelvis and PSA as per PCWG3 criteria.",[19],"Metastatic Prostate Cancer",[21],"Prostatic Neoplasms","INTERVENTIONAL","TREATMENT",[25],"PHASE2",{"count":27,"type":28},51,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":38},"DRUG","High dose testosterone","High dose testosterone is administered subcutaneously once monthly until progression or toxicity",[35,36,37],"ATM","CDK12","CHEK2",[39],"Bipolar androgen therapy",[41],{"measure":42,"description":43,"timeFrame":44},"PSA response","PSA response as measured by a 50% decline from baseline maintained for 12 weeks","12 weeks",[],"MALE","18 Years",null,false,{"inclusion":51,"exclusion":64,"raw_text":75},[52,53,54,55,56,57,58,59,60,61,62,63],"Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information","Histologically or cytologically confirmed adenocarcinoma of the prostate","Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue\u002Fantagonist therapy","Castration resistant prostate cancer as defined by serum testosterone \\\u003C 50 ng\u002Fml and one of the following:","PSA level of at least 2 ng\u002Fml that has risen on at least 2 successive occasions at least 1 week apart.","Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)","Progression of metastatic bone disease on bone scan with \\> 2 new lesions","Presence of metastatic disease on bone or CT scan","Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.).","Asymptomatic or minimal cancer related symptoms","Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C 2","Presence of inactivating mutations in ATM, CDK12 or CHEK2 as determined by a CLIA level assay for DNA sequencing.",[65,66,67,68,69,70,71,72,73,74],"Currently receiving active therapy for other neoplastic disorders will not be eligible.","Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendrocrine differentiation without morphologic evidence is not exclusionary)","Known parenchymal brain metastasis","Liver metastases","Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \\> 2.5 x ULN or total bilirubin \\> ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia).","Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \\\u003C35 % at baseline","Patients with pain attributable to their prostate cancer and requiring the use of opioids.","Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll.","Presence of dementia, psychiatric illness, and\u002For social situations limiting compliance with study requirements or understanding and\u002For giving of informed consent.","Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained.","Inclusion Criteria:\n\n* Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy must be maintained on effective GnRH analogue\u002Fantagonist therapy\n* Castration resistant prostate cancer as defined by serum testosterone \\\u003C 50 ng\u002Fml and one of the following:\n\n  * PSA level of at least 2 ng\u002Fml that has risen on at least 2 successive occasions at least 1 week apart.\n  * Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)\n  * Progression of metastatic bone disease on bone scan with \\> 2 new lesions\n* Presence of metastatic disease on bone or CT scan\n* Patients must have progressed on 1 next-generation AR-signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide, darolutamide, etc.).\n* Asymptomatic or minimal cancer related symptoms\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\\u003C 2\n* Presence of inactivating mutations in ATM, CDK12 or CHEK2 as determined by a CLIA level assay for DNA sequencing.\n\nExclusion Criteria:\n\n* Currently receiving active therapy for other neoplastic disorders will not be eligible.\n* Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical evidence of neuroendrocrine differentiation without morphologic evidence is not exclusionary)\n* Known parenchymal brain metastasis\n* Liver metastases\n* Active or symptomatic viral hepatitis or chronic liver disease AST or ALT \\> 2.5 x ULN or total bilirubin \\> ULN (unless Gilbert's syndrome is the etiology of hyperbilirubinemia).\n* Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \\\u003C35 % at baseline\n* Patients with pain attributable to their prostate cancer and requiring the use of opioids.\n* Tumor causing urinary outlet obstruction that requires catheterization for voiding. Patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll.\n* Presence of dementia, psychiatric illness, and\u002For social situations limiting compliance with study requirements or understanding and\u002For giving of informed consent.\n* Any condition(s), medical or otherwise, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained.",[77,78],"ADULT","OLDER_ADULT",[80,95,108,121,133,146,158,171,183,197,209,222,235,248,259,273,289],{"facility":81,"status":8,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":92},"Rocky Mountain Regional VA Medical Center, Aurora, CO","Aurora","Colorado","80045","United States",[87],{"name":88,"role":89,"phone":90,"email":91},"Daniel Bowles, MD","CONTACT","720-723-6498","Daniel.Bowles@va.gov",{"lat":93,"lon":94},39.72943,-104.83192,{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":85,"contacts":100,"geoPoint":105},"VA Connecticut Healthcare System West Haven Campus, West Haven, CT","West Haven","Connecticut","06516-2770",[101],{"name":102,"role":89,"phone":103,"email":104},"Herta Chao, MD","203-937-3421","Herta.Chao@va.gov",{"lat":106,"lon":107},41.27065,-72.94705,{"facility":109,"status":8,"city":110,"state":111,"zip":112,"country":85,"contacts":113,"geoPoint":118},"North Florida\u002FSouth Georgia Veterans Health System, Gainesville, FL","Gainesville","Florida","32608",[114],{"name":115,"role":89,"phone":116,"email":117},"Jess D Delaune, MD","352-988-7504","Jess.Delaune@va.gov",{"lat":119,"lon":120},29.65163,-82.32483,{"facility":122,"status":8,"city":123,"state":111,"zip":124,"country":85,"contacts":125,"geoPoint":130},"Orlando VA Medical Center, Orlando, FL","Orlando","32803",[126],{"name":127,"role":89,"phone":128,"email":129},"Priya K Gopalan, MD","407-631-2389","Priya.Gopalan@va.gov",{"lat":131,"lon":132},28.53834,-81.37924,{"facility":134,"status":8,"city":135,"state":136,"zip":137,"country":85,"contacts":138,"geoPoint":143},"Atlanta VA Medical and Rehab Center, Decatur, GA","Decatur","Georgia","30033",[139],{"name":140,"role":89,"phone":141,"email":142},"Maria Ribeiro, MD","404-728-7680","Maria.Ribeiro@va.gov",{"lat":144,"lon":145},33.77483,-84.29631,{"facility":147,"status":8,"city":148,"state":149,"zip":150,"country":85,"contacts":151,"geoPoint":155},"Robley Rex VA Medical Center, Louisville, KY","Louisville","Kentucky","40206-1433",[152],{"name":153,"role":89,"phone":154},"Fred Hendler, MD","502-287-3515",{"lat":156,"lon":157},38.25424,-85.75941,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":85,"contacts":163,"geoPoint":168},"Kansas City VA Medical Center, Kansas City, MO","Kansas City","Missouri","64128",[164],{"name":165,"role":89,"phone":166,"email":167},"Linda Verkruyse, MD","817-681-7115","Linda.Verkruyse@va.gov",{"lat":169,"lon":170},39.09973,-94.57857,{"facility":172,"status":8,"city":173,"state":161,"zip":174,"country":85,"contacts":175,"geoPoint":180},"St. Louis VA Medical Center John Cochran Division, St. Louis, MO","St Louis","63106",[176],{"name":177,"role":89,"phone":178,"email":179},"Eric Knoche, MD","314-289-6305","Eric.Knoche@va.gov",{"lat":181,"lon":182},38.62727,-90.19789,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":85,"contacts":188,"geoPoint":194},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705",[189],{"name":190,"role":89,"phone":191,"phoneExt":192,"email":193},"Rhonda Bitting, MD","919-286-0411","17-5441","Rhonda.Bitting@va.gov",{"lat":195,"lon":196},35.99403,-78.89862,{"facility":198,"status":8,"city":199,"state":186,"zip":200,"country":85,"contacts":201,"geoPoint":206},"Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC","Salisbury","28144",[202],{"name":203,"role":89,"phone":204,"phoneExt":205},"Michael Goodman, MD","704-638-9000","15038",{"lat":207,"lon":208},35.67097,-80.47423,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":85,"contacts":214,"geoPoint":219},"VA Portland Health Care System, Portland, OR","Portland","Oregon","97239",[215],{"name":216,"role":89,"phone":217,"email":218},"Julie Graff, MD","503-220-8262","Julie.Graff@va.gov",{"lat":220,"lon":221},45.52345,-122.67621,{"facility":223,"status":8,"city":224,"state":225,"zip":226,"country":85,"contacts":227,"geoPoint":232},"Ralph H. Johnson VA Medical Center, Charleston, SC","Charleston","South Carolina","29401-5799",[228],{"name":229,"role":89,"phone":230,"email":231},"Steven Savage, MD","843-792-4531","Stephen.Savage@va.gov",{"lat":233,"lon":234},32.77632,-79.93275,{"facility":236,"status":8,"city":237,"state":238,"zip":239,"country":85,"contacts":240,"geoPoint":245},"Memphis VA Medical Center, Memphis, TN","Memphis","Tennessee","38104-2127",[241],{"name":242,"role":89,"phone":243,"phoneExt":244},"Alva Weir, MD","901-523-8990","6853",{"lat":246,"lon":247},35.14953,-90.04898,{"facility":249,"status":8,"city":250,"state":238,"zip":251,"country":85,"contacts":252,"geoPoint":256},"Tennessee Valley Healthcare System Nashville Campus, Nashville, TN","Nashville","37212-2637",[253],{"name":254,"role":89,"phone":255},"Sally York, MD","615-873-6979",{"lat":257,"lon":258},36.16589,-86.78444,{"facility":260,"status":261,"city":262,"state":263,"zip":264,"country":85,"contacts":265,"geoPoint":270},"Michael E. DeBakey VA Medical Center, Houston, TX","NOT_YET_RECRUITING","Houston","Texas","77030",[266],{"name":267,"role":89,"phone":268,"email":269},"Anita Sabichi, MD","713-798-3750","Anita.Sabichi@va.gov",{"lat":271,"lon":272},29.76328,-95.36327,{"facility":274,"status":8,"city":275,"state":276,"zip":277,"country":85,"contacts":278,"geoPoint":286},"VA Puget Sound Health Care System Seattle Division, Seattle, WA","Seattle","Washington","98108-1532",[279,283],{"name":280,"role":89,"phone":281,"email":282},"Robert B Montgomery, MD","(206) 277-6878","Robert.Montgomery@va.gov",{"name":284,"role":285},"Robert B. Montgomery, MD","PRINCIPAL_INVESTIGATOR",{"lat":287,"lon":288},47.60621,-122.33207,{"facility":290,"status":8,"city":291,"state":292,"zip":293,"country":85,"contacts":294,"geoPoint":299},"William S. Middleton Memorial Veterans Hospital, Madison, WI","Madison","Wisconsin","53705-2254",[295],{"name":296,"role":89,"phone":297,"email":298},"David Kosoff, MD","608-256-1901","David.Kosoff@va.gov",{"lat":300,"lon":301},43.07305,-89.40123,[303,304],{"name":280,"role":89,"phone":281,"email":282},{"name":305,"role":89,"phone":306,"email":307},"Elahe Mostaghel, MD","(206) 762-1010","emostagh@fhcrc.org",[309],{"name":284,"affiliation":274,"role":285},[],[],{"nct_id":4,"conditions":313,"biomarkers":315},[314],"Prostate Carcinoma",[316,317,318],"ATM Gene","CDK12 Gene","Serine\u002FThreonine-Protein Kinase Chk2",{"nct_id":4,"found":15,"summary":320,"prompt_version":330},{"design":321,"status":322,"heading":323,"summary":324,"follow_up":325,"word_count":326,"commitments":327,"compensation":328,"drugs_mentioned":329},"This is an unblinded, three-group study (meaning you and your doctors will know you are receiving the treatment) that will include 51 participants.","completed","High Dose Testosterone for Prostate Cancer with Specific Gene Changes","This study is testing high dose testosterone for men with metastatic prostate cancer (cancer that has spread). Researchers want to see if this treatment works well for men whose tumors have specific changes in their ATM, CDK12, or CHEK2 genes. These gene changes are related to how cells repair DNA. You would receive high dose testosterone as a shot under your skin once a month. The study will measure if your PSA (prostate-specific antigen) levels respond to the treatment after 12 weeks. The study is currently unclear on its recruitment status and plans to enroll 51 participants.","Not specified.",97,"You would receive high dose testosterone shots once a month until your disease gets worse or you experience side effects. You would also have frequent safety checks, including recording side effects, vital signs, and blood tests.","Not stated in the trial record.",[32],"v2"]