[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443430":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":53,"centralContacts":57,"locations":62,"responsibleParty":81,"collaborators":83,"id":87,"slug":38,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":38,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":38,"enrollmentInfo":95,"targetDuration":38,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":38,"overallStatus":65,"whyStopped":38,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group I (education exercise packet, FitBit)","ACTIVE_COMPARATOR","Patients receive general education exercise packet with instruction to exercise regularly for up to 150 minutes weekly. Patients also wear a FitBit daily over 16 weeks.",[13,14,15,16],"Behavioral: Educational Intervention","Device: FitBit","Other: Quality-of-Life Assessment","Other: Questionnaire Administration",{"label":18,"type":19,"description":20,"interventionNames":21},"Group II (exercise program FitBit)","EXPERIMENTAL","Patients participate in supervised and self-directed exercise sessions over 60 minutes BIW for up to 16 weeks. Patients also wear a FitBit daily over 16 weeks.",[22,14,15,16],"Behavioral: Exercise Intervention",[24,34,39,44,50],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Educational Intervention","Receive general education exercise packet",[9],[30,31,32,33],"Education for Intervention","Intervention by Education","Intervention through Education","Intervention, Educational",{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Exercise Intervention","Participate in supervised and self-directed exercise sessions",[18],null,{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":38},"DEVICE","FitBit","Wear FitBit for activity tracking",[9,18],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Quality-of-Life Assessment","Ancillary studies",[9,18],[49],"Quality of Life Assessment",{"type":6,"name":51,"description":46,"armGroupLabels":52,"otherNames":38},"Questionnaire Administration",[9,18],[54],{"name":55,"affiliation":5,"role":56},"Christopher J Logothetis","PRINCIPAL_INVESTIGATOR",[58],{"name":55,"role":59,"phone":60,"phoneExt":38,"email":61},"CONTACT","7135637210","clogothe@mdanderson.org",[63],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States",{"type":71,"coordinates":72},"Point",[73,74],-95.36327,29.76328,{"lat":74,"lon":73},[77,80],{"name":78,"role":59,"phone":79,"phoneExt":38,"email":38},"Christopher J. Logothetis","713-792-2830",{"name":78,"role":56,"phone":38,"phoneExt":38,"email":38},{"type":82,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[84],{"name":85,"class":86},"National Cancer Institute (NCI)","NIH","100443430",false,"NCT05054296","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Risk Factor Modification Program and Continuous Fitbit Monitoring","Modifying Metabolic Syndrome and Cardiovascular Risk for Prostate Cancer Patients on ADT Using a Supervised Exercise Program and Continuous Fitbit Monitoring","Inclusion Criteria:\n\n* Willing and able to provide written informed consent\n* Histologically or cytologically confirmed adenocarcinoma of the prostate\n* Presence of metastatic disease documented on imaging studies (bone scan, computed tomography \\[CT\\] and\u002For magnetic resonance imaging \\[MRI\\]) or biochemical recurrence\u002Frefractoriness following local therapy (prostatectomy or radiation)\n* Stable or improving disease activity as demonstrated by stable or improving PSA over at least 2 months\n* On gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or status post-surgical castration for at least 3 months\n* Combination ADT with abiraterone or enzalutamide is permitted\n* Anticipation to remain hypogonadal for at least 6 months subsequently\n* Asymptomatic bone metastasis is permissible (exercise will be modified and patients monitored)\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Patients must be able to finish a maximal exercise stress test which will be assessed by cardiopulmonary exercise testing using a standardized protocol \\^70 supervised by a cardiologist\n* Hemoglobin \\>= 9.0 g\u002FdL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Platelet count \\>=75,000\u002FuL independent of transfusion and\u002For growth factors within 3 months prior to enrollment\n* Access to a smart phone with android or iPhone OS (iOS) operating systems\n* Able to speak and comprehend English\n\nExclusion Criteria:\n\n* Current use of any other systemic therapy for prostate cancer with the exception of gonadotrophin releasing hormone (GnRH) agonists\u002Fantagonists, abiraterone, enzalutamide, bisphosphonates or RANK-ligand inhibitors (for bone metastases) which are allowed\n* Any underlying comorbid medical or psychiatric condition, which in the opinion of the Investigator, will make participation in our exercise intervention hazardous or obscure the interpretation of adverse events\n* Inability to walk 400 meters or undertake upper and lower limb exercise, and resistance training in the previous 3 months\n* Chemotherapy treatment within 28 days of study enrollment\n* Symptomatic bone metastasis\n* Any investigational pharmaceutical products\n* Radiation therapy or surgical intervention for prior bone metastasis\n* Clinically significant active malignancy other than prostate cancer\n* Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\\>= 450 m\u002Fsec)\n* Clinically significant heart disease that may impact safety of independent or supervised exercise including preexisting coronary artery disease, myocardial infarction or arterial thrombotic events in the past 6 months, severe or unstable angina, history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de pointes), New York Heart Association Class III-IV heart disease or cardiac ejection fraction measurement of \\\u003C 40% at baseline\n* Untreated symptomatic spinal cord compressions\n* Prisoners or subjects who are involuntarily incarcerated\n* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness","MALE","18 Years",{"count":96,"type":97},200,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","This phase II trial studies how well an exercise program and continuous Fitbit monitoring work for managing metabolic syndrome and cardiovascular disease risk in patients with prostate cancer that has spread to other places in the body (metastatic) or has come back (recurrent) and does not response to treatment (refractory) and are receiving androgen deprivation therapy. Balancing treatment efficacy, drug side effects, and competing comorbidities with prostate cancer is essential. This trial is being done to learn if an exercise program can help to improve metabolic syndrome and cardiovascular (heart) fitness in prostate cancer patients who are receiving androgen deprivation therapy.",[103,104,105,106,107],"Biochemically Recurrent Prostate Carcinoma","Metastatic Prostate Adenocarcinoma","Stage IV Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","2023-03-28",{"date":110,"type":111},"2023-03-29","ACTUAL",{"date":113,"type":111},"2020-03-23",{"date":115,"type":97},"2027-02-02",{"name":5,"class":6},1]