[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606866":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":70,"collaborators":73,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":10,"enrollmentInfo":87,"targetDuration":10,"studyType":90,"phases":10,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Ankara Etlik City Hospital","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Androgen Receptor Pathway Inhibitor Cohort",null,"Men with metastatic hormone-sensitive prostate cancer receiving androgen receptor pathway inhibitors (abiraterone acetate, apalutamide, enzalutamide, or darolutamide) in combination with standard androgen deprivation therapy. Participants will be assessed at baseline, 3 months, and 6 months for quality of life, cognitive function, fatigue, depression, sleep quality, clinical parameters, and treatment-related adverse events.",[13],"Drug: Androgen Receptor Pathway Inhibitors (ARPIs)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Androgen Receptor Pathway Inhibitors (ARPIs)","Men with metastatic hormone-sensitive prostate cancer will receive androgen receptor pathway inhibitors (abiraterone acetate, apalutamide, enzalutamide, or darolutamide) in addition to standard androgen deprivation therapy. The choice of ARPI will be determined by routine clinical practice. The study does not assign treatments; it observes patient outcomes under real-world conditions.",[9],[21,22,23,24],"Abiraterone acetate","Apalutamide","Enzalutamide","Darolutamide",[26],{"name":27,"affiliation":5,"role":28},"Galip Can Uyar, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","+905065963812","g.can_uyar@hotmail.com",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Enes Yeşilbaş, MD","+905321795590","yesilbas126@gmail.com",[39,55],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":10,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Etlik City Hospital Medical Oncology Department","RECRUITING","Ankara","Yenimahalle","06270","Turkey (Türkiye)",{"type":47,"coordinates":48},"Point",[49,50],32.85427,39.91987,{"lat":50,"lon":49},[53,54],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},{"facility":56,"status":41,"city":42,"state":57,"zip":10,"country":45,"countryCode":10,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Gazi University Medical Oncology Department","Çankaya",{"type":47,"coordinates":59},[49,50],{"lat":50,"lon":49},[62,66],{"name":63,"role":31,"phone":64,"phoneExt":10,"email":65},"Orhun Akdoğan, MD","+905375831594","orhunakdogan@gmail.com",{"name":67,"role":31,"phone":68,"phoneExt":10,"email":69},"Osman Sütcüoğlu, MD","+905376679724","sutcuogluo@gmail.com",{"type":28,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Galip Can Uyar","Medical Oncology Specialist",[74],{"name":75,"class":76},"Gazi University","OTHER","100606866","quality-of-life-functional-and-cognitive-outcomes-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-100606866",false,"NCT07181122","Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer","Prospective Observational Evaluation of Quality of Life, Functional Status, and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer Undergoing Androgen Receptor Pathway Inhibitor Therapy","PRO-MIND","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically or cytologically confirmed metastatic hormone-sensitive prostate cancer (mHSPC)\n* Planned initiation of androgen deprivation therapy (ADT) plus an androgen receptor pathway inhibitor (abiraterone, apalutamide, or enzalutamide) as part of routine clinical care\n* Ability to complete patient-reported outcome questionnaires (FACT-Cog, FACT-F, PHQ-9, PSQI)\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Prior systemic therapy for metastatic prostate cancer (except ≤3 months of ADT)\n* Known history of severe cognitive impairment that precludes completion of questionnaires\n* Concurrent active malignancy requiring systemic treatment\n* Inability to comply with study procedures or follow-up\n* Any condition judged by the investigator to compromise participation or data integrity","MALE","18 Years",{"count":88,"type":89},102,"ESTIMATED","OBSERVATIONAL","This prospective observational study will evaluate quality of life, functional status, and cognitive outcomes in men with metastatic hormone-sensitive prostate cancer (mHSPC) receiving androgen receptor pathway inhibitors (ARPIs) in addition to standard androgen deprivation therapy. ARPIs in this study include abiraterone acetate, apalutamide, enzalutamide, and darolutamide, depending on local availability. A total of 102 patients will be enrolled from two academic oncology centers in Türkiye.\n\nParticipants will be assessed at baseline, 3 months, and 6 months using validated Turkish versions of established questionnaires: Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Patient Health Questionnaire-9 (PHQ-9), and Pittsburgh Sleep Quality Index (PSQI). Clinical parameters, ECOG performance status, routine laboratory results, and treatment-related adverse events will also be recorded.\n\nThe primary outcomes are longitudinal changes in FACT-Cog and FACT-F scores. Secondary outcomes include changes in depression, sleep quality, laboratory results, and adverse events. This study will provide real-world evidence on how ARPI therapy affects cognitive health and quality of life in patients with mHSPC.",[93],"Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)",[95,96,97,98,22,23,24,99,100,101,102,103,104],"Prostate cancer","mHSPC","Androgen receptor pathway inhibitors","Abiraterone","Quality of life","Cognitive function","Fatigue","Depression","Sleep quality","Patient-reported outcomes","2026-04-26",{"date":107,"type":108},"2026-04-28","ACTUAL",{"date":110,"type":108},"2025-10-22",{"date":112,"type":89},"2026-09-15",{"name":5,"class":6},2]