[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614343":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":32,"responsibleParty":55,"collaborators":18,"id":57,"slug":18,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":18,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":18,"overallStatus":75,"whyStopped":18,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Miami","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Testosterone cypionate","EXPERIMENTAL","Participants will self-inject 100mg of testosterone cypionate once per week for 12 months",[13],"Drug: Testosterone cypionate",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Thomas Masterson, MD","PRINCIPAL_INVESTIGATOR",[24,28],{"name":21,"role":25,"phone":26,"phoneExt":18,"email":27},"CONTACT","305-243-6260","TMasterson@med.miami.edu",{"name":29,"role":25,"phone":30,"phoneExt":18,"email":31},"Laura Angulo Llanos","305-243-4850","lxa2084@med.miami.edu",[33,48],{"facility":34,"status":18,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Desai Sethi Urology Institute","Miami","Florida","33136","United States",{"type":40,"coordinates":41},"Point",[42,43],-80.19366,25.77427,{"lat":43,"lon":42},[46],{"name":47,"role":22,"phone":18,"phoneExt":18,"email":18},"Thomas Masterson",{"facility":49,"status":18,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":50,"geoPoint":52,"contacts":53},"Sylvester Comprehensive Cancer Center",{"type":40,"coordinates":51},[42,43],{"lat":43,"lon":42},[54],{"name":47,"role":22,"phone":18,"phoneExt":18,"email":18},{"type":22,"investigatorFullName":47,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Assistant Professor of Clinical Urology","100614343",false,"NCT07278362","Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance","Safety of Intramuscular Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance","Inclusion Criteria:\n\n* Males aged ≥ 18 years old\n* Newly diagnosed with low-risk prostate cancer initially confirmed by fusion guided prostate biopsy (transrectal or trans perineal) by multiparametric MRI, and had a second confirmatory biopsy within the last 12 months\n* Males diagnosed with low-risk prostate cancer undergoing active surveillance\n* Two confirmatory testosterone levels \\\u003C300 ng\u002FdL (taken before 10am), with at least 24 hours and no more than 90 days between the two tests\n* Symptoms of low testosterone (Aging Male's Symptoms Score \\>27)\n* Able to obtain Testosterone medication through insurance or out-of-pocket\n* Willing and able to provide written informed consent and able to comply with study requirements\n\nExclusion Criteria:\n\n* Males \\\u003C18 years old\n* History of Testosterone Replacement Therapy (TRT) within the past year.\n* Current use of TRT\n* Diagnosis of Gleason score 7 (Grade Group 2) prostate cancer or higher on diagnostic or confirmatory biopsy\n* PSA \\>10 ng\u002FmL at baseline\n* Hematocrit \\> 51% at baseline\n* T3 or T4 disease\n* Uncontrolled cardiovascular disease and sleep apnea\n* History of breast cancer\n* Any other condition or situation which, in the opinion of the investigator, could impact patient safety, prevent successful data collection, or reduce the likelihood of successful study participation\n* Unable or unwilling to obtain Testosterone medication through insurance or out-of-pocket\n* Unable or unwilling to provide informed consent or comply with study requirements","MALE","18 Years",{"count":66,"type":67},35,"ESTIMATED","INTERVENTIONAL",[70],"PHASE4","The purpose of this study is evaluate the safety of testosterone replacement therapy in men with newly diagnosed low-risk prostate cancer and hypogonadism on active surveillance.",[73,74],"Prostate Cancer","Hypogonadism, Male","NOT_YET_RECRUITING","2026-02-20",{"date":78,"type":79},"2026-02-23","ACTUAL",{"date":81,"type":67},"2026-05-31",{"date":83,"type":67},"2032-05-31",{"name":5,"class":6},2]