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Life sciences · Observational Study
ClinicalTrials.gov · October 8, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07181122). This is a study registration, not published results. Lead sponsor: Ankara Etlik City Hospital. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 230 participants (ACTUAL). Conditions: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Interventions: DRUG: Androgen Receptor Pathway Inhibitors (ARPIs). Primary outcome measures: Change From Baseline in Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Total Score , Baseline, 3 months, and 6 months after treatment initiation; Change From Baseline in Functional Assessment of Cancer Therapy - Fatigue (FACT-F) Score , Baseline, 3 months, and 6 months after treatment initiation. Brief summary: 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. Participants 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. The 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.