[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614343":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":32,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":18,"overallStatus":77,"whyStopped":18,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"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",[33,49],{"facility":34,"status":18,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Desai Sethi Urology Institute","Miami","Florida","33136","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-80.19366,25.77427,{"lat":44,"lon":43},[47],{"name":48,"role":22,"phone":18,"phoneExt":18,"email":18},"Thomas Masterson",{"facility":50,"status":18,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":53,"contacts":54},"Sylvester Comprehensive Cancer Center",{"type":41,"coordinates":52},[43,44],{"lat":44,"lon":43},[55],{"name":48,"role":22,"phone":18,"phoneExt":18,"email":18},{"type":22,"investigatorFullName":48,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Assistant Professor of Clinical Urology","100614343","phase-4-testosterone-replacement-therapy-in-hypogonadal-patients-with-prostate-cancer-under-active-surveillance-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":68,"type":69},35,"ESTIMATED","INTERVENTIONAL",[72],"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.",[75,76],"Prostate Cancer","Hypogonadism, Male","NOT_YET_RECRUITING","2026-02-20",{"date":80,"type":81},"2026-02-23","ACTUAL",{"date":83,"type":69},"2026-05-31",{"date":85,"type":69},"2032-05-31",{"name":5,"class":6},2]