[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504580":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":48,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Oncology Institute of Southern Switzerland","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm treated with lifestyle intervention","EXPERIMENTAL","Patients with prostate cancer will receive a lifestyle intervention on diet and physical activity.",[13],"Behavioral: Lifestyle intervention",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Lifestyle intervention","12-week lifestyle intervention including adherence to a personalized balanced dietary regimen (low total fat, low saturated fat, high ω3 fatty acids, optimized protein content, low simple sugars) combined with regular physical activity (including physiotherapy sessions and self-training).",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Ursula Vogl, MD","CONTACT","+41 91 811 84 63","ursula.vogl@eoc.ch",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Luigi Tortola, PhD","+41 91 811 96 68","luigi.tortola@eoc.ch",[32],{"facility":33,"status":34,"city":35,"state":20,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Oncology Institute of Southern Switzerland (IOSI)","RECRUITING","Bellinzona","6500","Switzerland","CH",{"type":40,"coordinates":41},"Point",[42,43],9.01703,46.19278,{"lat":43,"lon":42},[46,47],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100504580","lifestyle-intervention-in-patients-with-metastatic-prostate-cancer-100504580",false,"NCT05850182","Lifestyle Intervention in Patients With Metastatic Prostate Cancer","A Pilot Study to Investigate the Effects of Lifestyle Intervention on Physical Activity and Diet in Patients With Metastatic Prostate Cancer Receiving Novel Hormonal Agents: the ACTIDIET-PRO Study","ACTIDIET-PRO","Inclusion Criteria:\n\n* Written informed consent according to ICH\u002FGCP regulations before registration.\n* Age ≥ 18 years\n* Histology of adenocarcinoma of the prostate\n* Patients with PCa receiving ADT alone or ADT+NHT (abiraterone, enzalutamide, apalutamide or darolutamide)\n* Rising PSA (two consecutively rising PSA levels \\> 25% above nadir at least three weeks apart), with no evidence of clinical or radiographic progression on instrumental evaluation\n* PSA doubling time \\> 8 weeks\n* Continuation of ongoing systemic treatment is deemed feasible by treating physician\n\nExclusion Criteria:\n\n* Ongoing treatment with docetaxel, cabazitaxel, radionuclides or investigational treatments\n* Evidence of clinical progression or progression of disease on imaging\n* Bone metastases excluding the safety of physical exercise\n* Prior confirmed severe osteoporosis or other diseases affecting the bone with history of fractures\n* Clinically significant cardiovascular disease (i.e. myocardial infarction within 6 months before screening; uncontrolled angina within 3 months before screening; congestive heart failure New York Heart Association class 3 or 4; history of clinically significant arrhythmias; uncontrolled hypertension indicated by systolic blood pressure \\> 170 mm Hg or diastolic blood pressure \\> 105 mm Hg at screening)\n* Clinically significant chronic obstructive pulmonary disease\n* Any concurrent disease or comorbid condition that interferes with the ability of the patient to participate in the study","MALE","18 Years",{"count":61,"type":62},30,"ESTIMATED","INTERVENTIONAL",[65],"NA","The proposed pilot study aims at determining the feasibility of a lifestyle intervention including adherence to a personalised dietary regimen combined with regular physical activity in patients newly diagnosed with prostate cancer under androgen deprivation therapy.",[68],"Prostate Cancer","2025-11-14",{"date":71,"type":72},"2025-11-18","ACTUAL",{"date":74,"type":72},"2023-11-27",{"date":76,"type":62},"2026-12-31",{"name":5,"class":6},1]